<856> NEAR-INFRARED SPECTROSCOPY |
4. VALIDATION AND VERIFICATION |
USP43–NF38
|
7161 |
24-Apr-2020 |
1-May-2020 |
NA
|
NA
|
In 4.1 Validation/4.1.1 Accuracy/Validation criteria/Criteria 1: Change Suitable agreement between SEP to: Suitable agreement between the standard error of prediction (SEP) |
<1042> CELL BANKING PRACTICES FOR RECOMBINANT BIOLOGICS |
5. CELL BANK CHARACTERIZATION |
USPNF Online
|
Online |
31-Mar-2023 |
1-May-2023 |
NA
|
NA
|
In Table 4: Change In vitro assayd,e + + +f to: In vitro assayd,e + −f + |
<800> HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS |
5. FACILITIES AND ENGINEERING CONTROLS/5.3 Compounding |
First Supplement to USP39–NF34
|
7721 |
27-May-2016 |
1-Jun-2016 |
USP40–NF35
|
USP40–NF35
|
First bullet in second paragraph: Change • Be externally vented through high-efficiency particulate air (HEPA) filtration to: • Be externally vented |
<800> HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS |
5. FACILITIES AND ENGINEERING CONTROLS/5.4 Containment Supplemental Engineering Controls |
First Supplement to USP40–NF35
|
Online |
17-Nov-2017 |
1-Dec-2017 |
USP42–NF37
|
Second Supplement to USP41–NF36
|
Line 5 of paragraph 1: Change containment reduction. to: contamination reduction. |
<855> NEPHELOMETRY AND TURBIDIMETRY |
5. FORMAZIN TURBIDITY STANDARDS |
USP42–NF37
|
7059 |
26-Apr-2019 |
1-May-2019 |
NA
|
NA
|
In paragraph 1: Change IUPAC Compendium of Chemical Technology, to: IUPAC Compendium of Chemical Terminology, |
<382> ELASTOMERIC COMPONENT FUNCTIONAL SUITABILITY IN PARENTERAL PRODUCT PACKAGING/DELIVERY SYSTEMS |
5. NEEDLE AND SPIKE ACCESS FUNCTIONAL SUITABILITY TESTS |
Second Supplement to USP43–NF38
|
Online |
18-Dec-2020 |
1-Jan-2021 |
NA
|
NA
|
In paragraph 4 of 5.1 Fragmentation/Cartridge systems/Procedure A: Change graticlule to: graticule |
<1207> STERILE PRODUCT PACKAGING−INTEGRITY EVALUATION |
5. PRODUCT–PACKAGE QUALITY REQUIREMENTS AND THE MAXIMUM ALLOWABLE LEAKAGE LIMIT/5.1 Sterility and Product Formulation Content must be Preserved; Gas Headspace Content Preservation is not Required |
First Supplement to USP39–NF34
|
7764 |
18-Nov-2016 |
1-Dec-2016 |
USP41–NF36
|
Second Supplement to USP40–NF35
|
Line 3 of paragraph 5: Change ultra-cold storage (<80°) to: ultra-cold storage (≤−80°) |
<1092> THE DISSOLUTION PROCEDURE: DEVELOPMENT AND VALIDATION |
6. ACCEPTANCE CRITERIA |
Second Supplement to USP43–NF38
|
Online |
20-Nov-2020 |
1-Dec-2020 |
NA
|
NA
|
In Row 1 of Table 5 and Table 6: Align Times with Acceptance Criteria |
<1661> EVALUATION OF PLASTIC PACKAGING SYSTEMS AND THEIR MATERIALS OF CONSTRUCTION WITH RESPECT TO THEIR USER SAFETY IMPACT |
6. APPLICABILITY AND APPLICATION OF <661.1> |
First Supplement to USP43–NF38
|
Online |
30-Oct-2020 |
1-Nov-2020 |
NA
|
NA
|
In 6.2 Application/6.2.5 Unaddressed Materials: Change physiochemical to: physicochemical |
<1430.5> ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA—SMALL ANGLE X-RAY SCATTERING AND SMALL ANGLE NEUTRON SCATTERING |
6. EXPERIMENTAL CONSIDERATIONS |
Second Supplement to USP42–NF37
|
Online |
22-Nov-2019 |
1-Dec-2019 |
NA
|
NA
|
In 6.2 Resolution/6.2.1 Size resolution: Change qmin < π/dmax π/dmax to: qmin < π/dmax |
GENERAL NOTICES TO USP-NF
|
6. TESTING PRACTICES AND PROCEDURES/6.50. Preparation of Solutions
|
First Supplement to USP37–NF32
|
6291 |
25-Jul-2014 |
1-Aug-2014 |
USP38–NF33
|
USP38–NF33
|
Line 6 of 6.50.20. Solutions: Change An expression such as “(1 in 10)” means that 1 part by volume of a liquid shall be diluted with a sufficient quantity of the diluent or solvent to make the volume of the finished solution 10 parts by volume. An expression such as “(20:5:2… Read More
Line 6 of 6.50.20. Solutions: Change An expression such as “(1 in 10)” means that 1 part by volume of a liquid shall be diluted with a sufficient quantity of the diluent or solvent to make the volume of the finished solution 10 parts by volume. An expression such as “(20:5:2)” means that the respective numbers of parts, by volume, of the designated liquids shall be mixed, unless otherwise indicated. to: An expression such as “(1 in 10)” means that 1 part by volume of a liquid shall be diluted with, or 1 part by weight of a solid shall be dissolved in, a sufficient quantity of the diluent or solvent to make the volume of the finished solution 10 parts by volume. An expression such as “(20:5:2)” means that the respective numbers of parts, by volume, of the designated liquids shall be mixed, unless otherwise indicated.
|
<800> HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS |
7. PERSONAL PROTECTIVE EQUIPMENT |
First Supplement to USP40–NF35
|
Online |
17-Nov-2017 |
1-Dec-2017 |
USP42–NF37
|
Second Supplement to USP41–NF36
|
Line 2 of paragraph 2: Change antineoplastic HDs. to: injectable antineoplastic HDs. |
BUFFER SOLUTIONS |
4. Standard Buffer Solutions/4.1 Preparation |
Second Supplement to USP36–NF31
|
6244 |
22-Nov-2013 |
1-Dec-2013 |
USP38–NF33
|
Second Supplement to USP37–NF32
|
Line 1 of 4. Boric Acid and Potassium Chloride 0.2 M: Change 12.73 g/L of boric acid to: 12.37 g/L of boric acid |
FLUOCINONIDE TOPICAL SOLUTION |
Alcohol content |
USP36–NF31
|
3618 |
22-Nov-2013 |
1-Dec-2013 |
USP38–NF33
|
Second Supplement to USP37–NF32
|
Line 1 of Standard solution: Change Dilute 20.0 mL of USP Alcohol to: Dilute 20.0 mL of alcohol |
<208> ANTI-FACTOR XA AND ANTI-FACTOR IIA ASSAYS FOR UNFRACTIONATED AND LOW MOLECULAR WEIGHT HEPARINS |
Anti-Factor Xa and Anti-Factor IIa Assays for Low Molecular Weight Heparins |
USP43–NF38
|
6611 |
31-Jul-2020 |
1-Aug-2020 |
NA
|
NA
|
Change Anti-Factor Xa Activity for Low Molecular Weight Heparin to: The following procedure is used where specified in the individual monographs. This assay can be performed manually in plastic tubes utilizing heated block stations or water bath.… Read More
Change Anti-Factor Xa Activity for Low Molecular Weight Heparin to: The following procedure is used where specified in the individual monographs. This assay can be performed manually in plastic tubes utilizing heated block stations or water bath. Microtiter plate equipment with a reader and automated coagulometer can improve reproducibility and throughput. Acetic acid solution (stopping solution) is used for manual and microtiter plate assay. Automated coagulometers measure initial kinetic rate, and because of that, stopping of the reaction is not needed. Anti-Factor Xa Activity for Low Molecular Weight Heparin
|
PRILOCAINE AND EPINEPHRINE INJECTION |
Assay for epinephrine |
USP35–NF30
|
4411 |
28-Sep-2012 |
1-Oct-2012 |
USP37–NF32
|
First Supplement to USP36–NF31
|
Line 7 of Procedure: Change
183.21/333.30
to:
183.20/333.29
AND Line 8 of Procedure: Change
183.21 and 333.30
to:
183.20 and 333.29 |
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE ACETATE OPHTHALMIC SUSPENSION |
Assay for hydrocortisone acetate |
USP41–NF36
|
2904 |
26-Oct-2018 |
1-Nov-2018 |
USP43–NF38
|
Second Supplement to USP41–NF36
|
Line 1: Change Proceed with Ophthalmic Suspension as directed in the Assay under Hydrocortisone Acetate Injectable Suspension. to: Standard preparation—Prepare as directed for Assay for… Read More
Line 1: Change Proceed with Ophthalmic Suspension as directed in the Assay under Hydrocortisone Acetate Injectable Suspension. to: Standard preparation—Prepare as directed for Assay for Steroids <351>, Standard Preparation, using USP Hydrocortisone Acetate RS. Assay preparation—Transfer to a separator an accurately measured volume of Ophthalmic Suspension, equivalent to about 50 mg of hydrocortisone acetate, and dilute with water to about 15 mL. Extract with four 25-mL portions of chloroform, filtering each portion through chloroform-washed cotton into a 250-mL volumetric flask. Add chloroform to volume, and mix. Pipet 10 mL of this solution into a 100-mL volumetric flask, add chloroform to volume, and mix. Pipet 10 mL of the resulting solution into a glass-stoppered, 50-mL conical flask, evaporate the chloroform on a steam bath just to dryness, cool, and dissolve the residue in 20.0 mL of alcohol. Procedure—Proceed as directed for Assay for Steroids <351>, Procedure. Calculate the quantity, in mg, of hydrocortisone acetate (C23H32O6) in each mL of Ophthalmic Suspension taken by the formula: 5(C/V)(AU/AS) in which V is the volume, in mL, of Ophthalmic Suspension taken; and the other terms are defined therein.
|
LIDOCAINE HYDROCHLORIDE AND DEXTROSE INJECTION |
Assay for lidocaine hydrochloride |
USPNF Online
|
Online |
24-Feb-2023 |
1-Mar-2023 |
NA
|
NA
|
Change Proceed with Injection as directed in the Assay for lidocaine hydrochloride under Lidocaine and Epinephrine Injection. to: Proceed with Injection as directed in the Assay for lidocaine hydrochloride under Lidocaine… Read More
Change Proceed with Injection as directed in the Assay for lidocaine hydrochloride under Lidocaine and Epinephrine Injection. to: Proceed with Injection as directed in the Assay for lidocaine hydrochloride under Lidocaine Hydrochloride and Epinephrine Injection.
|
POTASSIUM CHLORIDE, POTASSIUM BICARBONATE, AND POTASSIUM CITRATE EFFERVESCENT TABLETS FOR ORAL SOLUTION |
Assay for potassium |
USP36–NF31
|
4843 |
31-May-2013 |
1-Jun-2013 |
USP37–NF32
|
USP37–NF32
|
Line 2: Change Potassium stock solution
and Standard preparations— to: Standard stock solution
and Standard solutions— AND Line 1 of Procedure: Change for Procedure in the Assay under Potassium Chloride Oral Solution. … Read More
Line 2: Change Potassium stock solution
and Standard preparations— to: Standard stock solution
and Standard solutions— AND Line 1 of Procedure: Change for Procedure in the Assay under Potassium Chloride Oral Solution. to: for Instrumental conditions and Analysis in the Assay under Potassium Chloride Oral Solution, except use Assay preparation instead of Sample solution.
|
POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE FOR EFFERVESCENT ORAL SOLUTION |
Assay for potassium |
USP36–NF31
|
4834 |
31-May-2013 |
1-Jun-2013 |
USP37–NF32
|
USP37–NF32
|
Line 2: Change Potassium stock solution
and Standard preparations— to: Standard stock solution
and Standard solutions— AND Line 1 of Procedure: Change for Procedure in the Assay under Potassium Chloride Oral Solution. to… Read More
Line 2: Change Potassium stock solution
and Standard preparations— to: Standard stock solution
and Standard solutions— AND Line 1 of Procedure: Change for Procedure in the Assay under Potassium Chloride Oral Solution. to: for Instrumental conditions and Analysis in the Assay under Potassium Chloride Oral Solution, except use Assay preparation instead of Sample solution.
|
POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION |
Assay for potassium |
USP36–NF31
|
4834 |
31-May-2013 |
1-Jun-2013 |
USP37–NF32
|
USP37–NF32
|
Line 2: Change Potassium stock solution
and Standard preparations— to: Standard stock solution
and Standard solutions— AND Line 1 of Procedure: Change for Procedure in the Assay under Potassium Chloride Oral Solution. to… Read More
Line 2: Change Potassium stock solution
and Standard preparations— to: Standard stock solution
and Standard solutions— AND Line 1 of Procedure: Change for Procedure in the Assay under Potassium Chloride Oral Solution. to: for Instrumental conditions and Analysis in the Assay under Potassium Chloride Oral Solution, except use Assay preparation instead of Sample solution.
|
RIFAMPIN, ISONIAZID, PYRAZINAMIDE, AND ETHAMBUTOL HYDROCHLORIDE TABLETS |
Assay for rifampin, isoniazid, and pyrazinamide |
USP36–NF31
|
5047 |
27-Sep-2013 |
1-Oct-2013 |
USP38–NF33
|
First Supplement to USP37–NF32
|
Line 12 of Procedure: Change the Standard preparation and the Assay preparation, respectively. to: the Assay preparation and the Standard preparation, respectively. |
Compound Undecylenic Acid Ointment |
Assay for zinc undecylenate |
USP35–NF30
|
4978 |
30-Nov-2012 |
1-Dec-2012 |
USP37–NF32
|
Second Supplement to USP36–NF31
|
Line 17 of Procedure: Change AU, AH, and AL to: AU, AS1, and AS2 |
COMPOUND UNDECYLENIC ACID OINTMENT |
Assay for zinc undecylenate |
USP36–NF31
|
5516 |
27-Sep-2013 |
1-Oct-2013 |
USP38–NF33
|
First Supplement to USP37–NF32
|
Line 15 of Procedure: Change 431.94 is the molecular weight of zinc undecylenate; to: Mr is the molecular weight of zinc undecylenate, 431.94; AND Line 16 of Procedure: Change 65.39 is the atomic weight of zinc; to: Ar… Read More
Line 15 of Procedure: Change 431.94 is the molecular weight of zinc undecylenate; to: Mr is the molecular weight of zinc undecylenate, 431.94; AND Line 16 of Procedure: Change 65.39 is the atomic weight of zinc; to: Ar is the atomic weight of zinc, 65.39; AND Line 19 of Procedure: Change CH and CL are the concentrations, in µg per mL, to: Cs1 and Cs2 are the concentrations, in µg per mL,
|
MINOCYCLINE FOR INJECTION |
Assay |
USP36–NF31
|
4375 |
31-May-2013 |
1-Jun-2013 |
USP37–NF32
|
USP37–NF32
|
Line 2: Change Mobile phase, Standard preparation, Resolution solution, and Chromatographic system—Proceed as directed in the Assay under Minocycline Hydrochloride. to: Mobile phase—Prepare a mixture of 0.2 M ammonium oxalate, 0.01 M edetate… Read More
Line 2: Change Mobile phase, Standard preparation, Resolution solution, and Chromatographic system—Proceed as directed in the Assay under Minocycline Hydrochloride. to: Mobile phase—Prepare a mixture of 0.2 M ammonium oxalate, 0.01 M edetate disodium, dimethylformamide, and tetrahydrofuran (600:180:120:80). Adjust with ammonium hydroxide to a pH of 7.2, and pass through a filter of 0.5-µm or finer porosity. Make adjustments if necessary (see System Suitability under Chromatography <621>). Standard preparation—Dissolve an accurately weighed quantity of USP Minocycline Hydrochloride RS in water to obtain a solution having a known concentration of about 500 µg of minocycline (C23H27N3O7) per mL. Use this solution within 3 hours. Resolution solution—Transfer 10 mg of USP Minocycline Hydrochloride RS to a 25-mL volumetric flask, add 20 mL of 0.2 M ammonium oxalate, and swirl to dissolve. Heat on a water bath at 60° for 180 minutes, and allow to cool. Dilute with water to volume, and mix. Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 280-nm detector and a 4.6-mm × 25-cm column that contains 5-µm packing L1, and is maintained at a constant temperature of about 40°. The flow rate is about 1.5 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the capacity factor, k´, is not less than 5.0 and not more than 11.5; the tailing factor for the analyte peak is not less than 0.9 and not more than 2.0; and the relative standard deviation for replicate injections is not more than 2.0%. Chromatograph the Resolution solution, and record the peak responses as directed for Procedure: the relative retention times are about 0.7 for epiminocycline and 1.0 for minocycline; and the resolution, R, between epiminocycline and minocycline is not less than 4.6. AND Line 1 of Procedure: Change Proceed as directed for Procedure in the Assay under Minocycline Hydrochloride. to: Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.
|
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ORAL SOLUTION |
Assay |
USP43–NF38
|
1438 |
26-Jun-2020 |
1-Jul-2020 |
NA
|
NA
|
In Procedure: Change (694.83/676.83)(25)CA(rU/rS) in which 694.83 and 676.83 are the molecular weights of atropine sulfate monohydrate and anhydrous atropine sulfate,… Read More
In Procedure: Change (694.83/676.83)(25)CA(rU/rS) in which 694.83 and 676.83 are the molecular weights of atropine sulfate monohydrate and anhydrous atropine sulfate, respectively; to: (694.84/676.82)(25)CA(rU/rS) in which 694.84 and 676.82 are the molecular weights of atropine sulfate monohydrate and anhydrous atropine sulfate, respectively;
|
CUPRIC SULFATE INJECTION |
Assay |
USP41–NF36
|
1112 |
30-Nov-2018 |
1-Dec-2018 |
USP43–NF38
|
USP42–NF37
|
Line 8 of Assay preparation: Change to bring the total sodium content of this flask to 13.5 mg. to: to bring the total sodium chloride content of this flask to 13.5 mg. |
VERAPAMIL HYDROCHLORIDE ORAL SUSPENSION |
Assay |
USP36–NF31
|
5558 |
31-May-2013 |
1-Jun-2013 |
USP37–NF32
|
USP37–NF32
|
Line 2 of Mobile phase: Change 0.01 M to: 0.01 N AND Line 7 of Assay preparation: Change 10-mL to: 100-mL |
ISOSORBIDE DINITRATE EXTENDED-RELEASE TABLETS |
Assay |
USP40–NF35
|
4710 |
29-Sep-2017 |
1-Oct-2017 |
USP42–NF37
|
First Supplement to USP41–NF36
|
Change Buffer solution, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Diluted Isosorbide Dinitrate. to: Buffer solution—Dissolve 15.4 g of ammonium… Read More
Change Buffer solution, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Diluted Isosorbide Dinitrate. to: Buffer solution—Dissolve 15.4 g of ammonium acetate in water, add 11.5 mL of glacial acetic acid, dilute with water to 1000 mL, and mix to obtain a solution having a pH of about 4.7. Mobile phase—Mix 350 mL of water, 100 mL of Buffer solution, and 550 mL of methanol. Cool to room temperature, dilute with water to 1000 mL, mix, degas, and filter. Make adjustments if necessary (see System Suitability under Chromatography <621>). Internal standard solution—Transfer a quantity of diluted nitroglycerin to a suitable volumetric flask, add about 60% of the flask volume of methanol, sonicate for 5 minutes, and shake for 30 minutes. Dilute with methanol to volume to obtain a solution having a concentration of about 3 mg of nitroglycerin per mL, and mix. Allow any undissolved material to settle, filter, and store the filtrate in an airtight container. Standard preparation—Transfer about 125 mg of recently mixed USP Diluted Isosorbide Dinitrate RS, accurately weighed, to a 50-mL volumetric flask, add about 30 mL of Mobile phase, shake for 30 minutes, dilute with Mobile phase to volume, and mix. Pipet 10 mL of the resulting solution into a 25-mL volumetric flask, and add 4.0 mL of Internal standard solution and 4 mL of dilute Buffer solution (1 in 10). Cool to room temperature, dilute with Mobile phase to volume, and mix to obtain a solution having a known concentration of about 0.25 mg of isosorbide dinitrate per mL, based on the quantity of USP Diluted Isosorbide Dinitrate RS weighed and the labeled content of isosorbide dinitrate. Pass a portion of this solution through a 0.45-µm filter. AND Change Procedure—Proceed as directed for Procedure in the Assay under Diluted Isosorbide Dinitrate. to: Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 220-nm detector and a 4-mm × 25-cm column that contains packing L1. The flow rate is about 1 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the resolution, R, between isosorbide dinitrate and nitroglycerin is not less than 2.0; and the relative standard deviation for replicate injections determined from the peak response ratios is not more than 2%. [NOTE—The relative retention times are about 0.75 for isosorbide dinitrate and 1.0 for nitroglycerin. The relative retention times for isosorbide mononitrates, if present, are about 0.38.] Procedure—Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.
|
MINOCYCLINE HYDROCHLORIDE ORAL SUSPENSION |
Assay |
USP36–NF31
|
4376 |
31-May-2013 |
1-Jun-2013 |
USP37–NF32
|
USP37–NF32
|
Line 2: Change Mobile phase and Chromatographic system—Proceed as directed in the Assay under Minocycline Hydrochloride. to: Mobile phase—Prepare a mixture of 0.2 M ammonium oxalate, 0.01 M edetate disodium, dimethylformamide, and tetrahydrofuran (600:180… Read More
Line 2: Change Mobile phase and Chromatographic system—Proceed as directed in the Assay under Minocycline Hydrochloride. to: Mobile phase—Prepare a mixture of 0.2 M ammonium oxalate, 0.01 M edetate disodium, dimethylformamide, and tetrahydrofuran (600:180:120:80). Adjust with ammonium hydroxide to a pH of 7.2, and pass through a filter of 0.5-µm or finer pore size. Make adjustments if necessary (see System Suitability under Chromatography <621>). Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 280-nm detector and a 4.6-mm × 25-cm column that contains 5-µm packing L1, and is maintained at a constant temperature of about 40°. The flow rate is about 1.5 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the capacity factor, k´, is not less than 5.0 and not more than 11.5; the tailing factor for the analyte peak is not less than 0.9 and not more than 2.0; and the relative standard deviation for replicate injections is not more than 2.0%. Chromatograph the Resolution solution, and record the peak responses as directed for Procedure: the relative retention times are about 0.7 for epiminocycline and 1.0 for minocycline; and the resolution, R, between epiminocycline and minocycline is not less than 4.6. AND Line 1 of Procedure: Change Proceed as directed for Procedure in the Assay under Minocycline Hydrochloride. to: Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.
|
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLETS |
Assay |
USP43–NF38
|
1439 |
26-Jun-2020 |
1-Jul-2020 |
NA
|
NA
|
In Procedure: Change 694.83/676.83)(250)CA(rU/rS) in which 694.83 and 676.83 are the molecular weights of atropine sulfate monohydrate and anhydrous atropine sulfate,… Read More
In Procedure: Change 694.83/676.83)(250)CA(rU/rS) in which 694.83 and 676.83 are the molecular weights of atropine sulfate monohydrate and anhydrous atropine sulfate, respectively; to: (694.84/676.82)(250)CA(rU/rS) in which 694.84 and 676.82 are the molecular weights of atropine sulfate monohydrate and anhydrous atropine sulfate, respectively;
|
POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES |
Assay |
USP36–NF31
|
4838 |
31-May-2013 |
1-Jun-2013 |
USP37–NF32
|
USP37–NF32
|
Line 2: Change Potassium stock solution
and Standard preparations— to: Standard stock solution
and Standard solutions— AND Line 1 of Procedure: Change for Procedure in the Assay under Potassium Chloride Oral Solution. … Read More
Line 2: Change Potassium stock solution
and Standard preparations— to: Standard stock solution
and Standard solutions— AND Line 1 of Procedure: Change for Procedure in the Assay under Potassium Chloride Oral Solution. to: for Instrumental conditions and Analysis in the Assay under Potassium Chloride Oral Solution, except use Assay preparation instead of Sample solution.
|
DIAZEPAM INJECTION |
Assay |
USP39–NF34
|
3445 |
27-May-2016 |
1-Jun-2016 |
USP40–NF35
|
USP40–NF35
|
Line 7 of Procedure: 50C / V(RU / RS) to: 50(C / V)(RU / RS) |
RISPERIDONE TABLETS |
Assay |
USP38–NF33
|
5195 |
29-Jan-2016 |
1-Feb-2016 |
USP40–NF35
|
Second Supplement to USP39–NF34
|
Line 4 of Procedure: Change Calculate the quantity, in mg, of risperidone to: Calculate the percentage of the labeled amount of risperidone |
CAPTOPRIL ORAL SOLUTION |
Assay |
USP35–NF30
|
2477 |
31-Jan-2013 |
1-Feb-2013 |
USP37–NF32
|
Second Supplement to USP36–NF31
|
Line 1 of Mobile phase: Change Prepare a filtered and degassed mixture of methanol and water (11:9) containing 0.5 mL of phosphoric acid.
to: Methanol and water (55:45) containing 0.5 mL/L of phosphoric acid. Filter, and degas. |
ATROPINE SULFATE TABLETS |
Assay |
USP35–NF30
|
2272 |
29-Mar-2013 |
1-Apr-2013 |
USP37–NF32
|
USP37–NF32
|
Line 9 of Procedure: Change RU and RS are as defined therein. to: RU and RS are the peak area ratios of atropine to homatropine. |
MINOCYCLINE HYDROCHLORIDE TABLETS |
Assay |
USP36–NF31
|
4378 |
31-May-2013 |
1-Jun-2013 |
USP37–NF32
|
USP37–NF32
|
Line 2: Change Mobile phase, Standard preparation, Resolution solution, and Chromatographic system—Proceed as directed in the Assay under Minocycline Hydrochloride. to: Mobile phase—Prepare a mixture of 0.2 M ammonium oxalate, 0.01 M… Read More
Line 2: Change Mobile phase, Standard preparation, Resolution solution, and Chromatographic system—Proceed as directed in the Assay under Minocycline Hydrochloride. to: Mobile phase—Prepare a mixture of 0.2 M ammonium oxalate, 0.01 M edetate disodium, dimethylformamide, and tetrahydrofuran (600:180:120:80). Adjust with ammonium hydroxide to a pH of 7.2, and pass through a filter of 0.5-µm or finer pore size. Make adjustments if necessary (see System Suitability under Chromatography <621>). Standard preparation—Dissolve an accurately weighed quantity of USP Minocycline Hydrochloride RS in water to obtain a solution having a known concentration of about 500 µg of minocycline (C23H27N3O7) per mL. Use this solution within 3 hours. Resolution solution—Transfer 10 mg of USP Minocycline Hydrochloride RS to a 25-mL volumetric flask, add 20 mL of 0.2 M ammonium oxalate, and swirl to dissolve. Heat on a water bath at 60° for 180 minutes, and allow to cool. Dilute with water to volume, and mix. Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 280-nm detector and a 4.6-mm × 25-cm column that contains 5-µm packing L1, and is maintained at a constant temperature of about 40°. The flow rate is about 1.5 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the capacity factor, k´, is not less than 5.0 and not more than 11.5; the tailing factor for the analyte peak is not less than 0.9 and not more than 2.0; and the relative standard deviation for replicate injections is not more than 2.0%. Chromatograph the Resolution solution, and record the peak responses as directed for Procedure: the relative retention times are about 0.7 for epiminocycline and 1.0 for minocycline; and the resolution, R, between epiminocycline and minocycline is not less than 4.6. AND Line 1 of Procedure: Change Proceed as directed for Procedure in the Assay under Minocycline Hydrochloride. to: Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.
|
GRANISETRON HYDROCHLORIDE INJECTION |
Assay |
USP36–NF31
|
3772 |
22-Nov-2013 |
1-Dec-2013 |
USP38–NF33
|
Second Supplement to USP37–NF32
|
Line 10 of Procedure: Change 100(312.41 / 348.87)(C/L)(rU / rS)
to: 100(312.41 / 348.87)(C/CU)(rU / rS)
AND Line of 14 of Procedure: Change L is… Read More
Line 10 of Procedure: Change 100(312.41 / 348.87)(C/L)(rU / rS)
to: 100(312.41 / 348.87)(C/CU)(rU / rS)
AND Line of 14 of Procedure: Change L is as defined above; to: CU is the nominal concentration, in mg per mL, of granisetron in the Assay preparation;
|
THEOPHYLLINE TABLETS |
Assay |
USP43–NF38
|
4328 |
28-Aug-2020 |
1-Sep-2020 |
NA
|
NA
|
Change Mobile phase, Internal standard solution, and Standard preparation—Prepare as directed in the Assay under Theophylline. to: Buffer solution—Transfer 2.72 g of sodium acetate trihydrate to a 2000-mL… Read More
Change Mobile phase, Internal standard solution, and Standard preparation—Prepare as directed in the Assay under Theophylline. to: Buffer solution—Transfer 2.72 g of sodium acetate trihydrate to a 2000-mL volumetric flask, add about 200 mL of water, and shake until dissolution is complete. Add 10.0 mL of glacial acetic acid, dilute with water to volume, and mix. Mobile phase—Transfer 70.0 mL of acetonitrile to a 1000-mL volumetric flask, dilute with Buffer solution to volume, and mix. Degas, and filter before using. Make adjustments if necessary (see System Suitability under Chromatography <621>). Internal standard solution—Transfer about 50 mg of theobromine, accurately weighed, to a 100-mL volumetric flask, dissolve in 10.0 mL of 6 N ammonium hydroxide, dilute with Mobile phase to volume, and mix. Standard preparation—Dissolve an accurately weighed quantity of USP Theophylline RS in Mobile phase, and dilute quantitatively, and stepwise if necessary, with Mobile phase to obtain a solution having a known concentration of about 1 mg per mL. Transfer 10.0 mL of this solution to a 100-mL volumetric flask, add 20.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix to obtain a solution having a known concentration of about 0.1 mg of USP Theophylline RS per mL. AND Change Chromatographic system—Proceed as directed in the Assay under Theophylline. to: (see Chromatography <621>)—The liquid chromatograph is equipped with a 280-nm detector and a 4-mm × 30-cm column that contains packing L1. The flow rate is about 1.0 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the resolution, R, between the theophylline and theobromine peaks is not less than 2.0, the tailing factor for the theophylline peak is not more than 2.0, and the relative standard deviation for replicate injections is not more than 1.5%. AND Change Procedure—Proceed as directed for Procedure in the Assay under Theophylline. to: Procedure—Separately inject equal volumes (between 10 µL and 25 µL) of the Standard preparation and the Assay preparation into the chromatograph, and measure the peak responses for the major peaks. The retention time of theophylline relative to that of theobromine is about 1.6.
|
FLUPHENAZINE DECANOATE INJECTION |
Assay |
USP36–NF31
|
3639 |
26-Jul-2013 |
1-Aug-2013 |
USP38–NF33
|
First Supplement to USP37–NF32
|
Line 11 of Standard preparation: Delete (1:5)
AND Line 8 of Assay preparation: Delete (1:5) |
ISOSORBIDE DINITRATE SUBLINGUAL TABLETS |
Assay |
USP41–NF36
|
2272 |
27-Apr-2018 |
1-May-2018 |
USP42–NF37
|
Second Supplement to USP41–NF36
|
Change Buffer solution, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Diluted Isosorbide Dinitrate. to: Buffer… Read More
Change Buffer solution, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Diluted Isosorbide Dinitrate. to: Buffer solution—Dissolve 15.4 g of ammonium acetate in water, add 11.5 mL of glacial acetic acid, dilute with water to 1000 mL, and mix to obtain a solution having a pH of about 4.7. Mobile phase—Mix 350 mL of water, 100 mL of Buffer solution, and 550 mL of methanol. Cool to room temperature, dilute with water to 1000 mL, mix, degas, and filter. Make adjustments if necessary (see System Suitability under Chromatography <621>). Internal standard solution—Transfer a quantity of diluted nitroglycerin to a suitable volumetric flask, add about 60% of the flask volume of methanol, sonicate for 5 minutes, and shake for 30 minutes. Dilute with methanol to volume to obtain a solution having a concentration of about 3 mg of nitroglycerin per mL, and mix. Allow any undissolved material to settle, filter, and store the filtrate in an airtight container. Standard preparation—Transfer about 125 mg of recently mixed USP Diluted Isosorbide Dinitrate RS, accurately weighed, to a 50-mL volumetric flask, add about 30 mL of Mobile phase, shake for 30 minutes, dilute with Mobile phase to volume, and mix. Pipet 10 mL of the resulting solution into a 25-mL volumetric flask, and add 4.0 mL of Internal standard solution and 4 mL of dilute Buffer solution (1 in 10). Cool to room temperature, dilute with Mobile phase to volume, and mix to obtain a solution having a known concentration of about 0.25 mg of isosorbide dinitrate per mL, based on the quantity of USP Diluted Isosorbide Dinitrate RS weighed and the labeled content of isosorbide dinitrate. Pass a portion of this solution through a 0.45-µm filter. AND Add Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 220-nm detector and a 4-mm × 25-cm column that contains packing L1. The flow rate is about 1 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the resolution, R, between isosorbide dinitrate and nitroglycerin is not less than 2.0; and the relative standard deviation for replicate injections determined from the peak response ratios is not more than 2%. [Note—The relative retention times are about 0.75 for isosorbide dinitrate and 1.0 for nitroglycerin. The relative retention times for isosorbide mononitrates, if present, are about 0.38.] AND Line 1 of Procedure: Change Proceed as directed for Procedure in the Assay under Diluted Isosorbide Dinitrate. to: Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.
|
POTASSIUM CHLORIDE FOR ORAL SOLUTION |
Assay |
USP36–NF31
|
4840 |
31-May-2013 |
1-Jun-2013 |
USP37–NF32
|
USP37–NF32
|
Line 2: Change Potassium stock solution
and Standard preparations— to: Standard stock solution
and Standard solutions— AND Line 1 of Procedure: Change for Procedure in the Assay under Potassium Chloride Oral Solution. to… Read More
Line 2: Change Potassium stock solution
and Standard preparations— to: Standard stock solution
and Standard solutions— AND Line 1 of Procedure: Change for Procedure in the Assay under Potassium Chloride Oral Solution. to: for Instrumental conditions and Analysis in the Assay under Potassium Chloride Oral Solution, except use Assay preparation 1 or Assay preparation 2 instead of Sample solution.
|
MOXIFLOXACIN OPHTHALMIC SOLUTION |
Assay |
USP36–NF31
|
4414 |
31-May-2013 |
1-Jun-2013 |
USP37–NF32
|
USP37–NF32
|
Line 4 of Resolution solution: Change 0.1 mg per mg and 0.001 mg per mg, to: 0.1 mg per mL and 0.001 mg per mL, |
CARTEOLOL HYDROCHLORIDE OPHTHALMIC SOLUTION |
Assay |
USP43–NF38
|
789 |
28-Aug-2020 |
1-Sep-2020 |
NA
|
NA
|
Change pH 6.0 buffer, Mobile phase, Diluent, Standard preparation, Resolution solution, and Chromatographic system—Proceed as directed in the Assay under Carteolol Hydrochloride. to: … Read More
Change pH 6.0 buffer, Mobile phase, Diluent, Standard preparation, Resolution solution, and Chromatographic system—Proceed as directed in the Assay under Carteolol Hydrochloride. to: Buffer, Mobile phase, Standard stock solution, Standard solution, System suitability stock solution, System suitability solution, Chromatographic system, and System suitability— Proceed as directed in the Assay under Carteolol Hydrochloride. AND Add Diluent—Prepare a mixture of Buffer and methanol (1:1). AND In all instances in Procedure: Change Standard preparation to: Standard solution
|
FUROSEMIDE TABLETS |
Assay |
USP43–NF38
|
2056 |
31-Jul-2020 |
1-Aug-2020 |
NA
|
NA
|
Change: Mobile phase, Diluting solution, System suitability solution, and Chromatographic system—Prepare as directed in the test for Related compounds under Furosemide. to: Mobile phase—Prepare a… Read More
Change: Mobile phase, Diluting solution, System suitability solution, and Chromatographic system—Prepare as directed in the test for Related compounds under Furosemide. to: Mobile phase—Prepare a filtered and degassed mixture of water, tetrahydrofuran, and glacial acetic acid (70:30:1). Make adjustments if necessary (see System Suitability under Chromatography <621>). Diluting solution—Dilute 22 mL of glacial acetic acid with a mixture of acetonitrile and water (50:50) to 1000 mL, and mix. System suitability solution—Dissolve suitable quantities of USP Furosemide RS and USP Furosemide Related Compound A RS in Diluting solution to obtain a solution containing about 20 µg per mL and 12 µg per mL, respectively. Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a detector capable of recording at both 254 nm and 272 nm and a 4.6-mm x 25-cm column that contains packing L1. [NOTE—The 2,4-dichloro-5-sulfamoylbenzoic acid impurity does not respond at 272 nm and the 2,4-bis(furfurylamino)-5-sulfamoylbenzoic acid impurity has a very intense absorbance at 254 nm.] The flow rate is about 1.0 mL per minute. Chromatograph the System suitability solution, and record the peak responses as directed for Procedure: the resolution, R, between furosemide and furosemide related compound A is not less than 2.5; and the relative standard deviation determined from furosemide is not more than 2.0%. [NOTE—The response for furosemide is at 254 nm.]
|
DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION |
Assay |
USPNF Online
|
Online |
25-Aug-2023 |
1-Sep-2023 |
NA
|
NA
|
In Chromatographic system and Procedure: Change C is the concentration, in mg per mL, of USP Dextromethorphan Hydrobromide RS, on the anhydrous basis, in the Standard preparation; to: C is the concentration, in mg per mL… Read More
In Chromatographic system and Procedure: Change C is the concentration, in mg per mL, of USP Dextromethorphan Hydrobromide RS, on the anhydrous basis, in the Standard preparation; to: C is the concentration, in mg per mL, of USP Dextromethorphan Hydrobromide RS in the Standard preparation;
|
CEFTAZIDIME FOR INJECTION |
Assay |
USP36–NF31
|
2887 |
31-Jan-2014 |
1-Feb-2014 |
USP38–NF33
|
Second Supplement to USP37–NF32
|
Line 6 of Procedure:
Change 250,000[C/W (100 −
m −
s)](rU / rS)
to: 25,000{C/[W (100 − m −
s)]}(rU / rS) |
POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS |
Assay |
USP36–NF31
|
4841 |
31-May-2013 |
1-Jun-2013 |
USP37–NF32
|
USP37–NF32
|
Line 5: Change Potassium stock solution
and Standard preparations— to: Standard stock solution
and Standard solutions— Line 1 of Procedure: Change in the Assay under Potassium Chloride Oral Solution. to: for Instrumental… Read More
Line 5: Change Potassium stock solution
and Standard preparations— to: Standard stock solution
and Standard solutions— Line 1 of Procedure: Change in the Assay under Potassium Chloride Oral Solution. to: for Instrumental conditions and Analysis in the Assay under Potassium Chloride Oral Solution, except use Assay preparation 1 or Assay preparation 2 instead of Sample solution.
|
ISOSORBIDE DINITRATE TABLETS |
Assay |
USP41–NF36
|
2270 |
27-Apr-2018 |
1-May-2018 |
USP42–NF37
|
Second Supplement to USP41–NF36
|
Change Buffer solution, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Diluted Isosorbide Dinitrate. to: Buffer… Read More
Change Buffer solution, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Diluted Isosorbide Dinitrate. to: Buffer solution—Dissolve 15.4 g of ammonium acetate in water, add 11.5 mL of glacial acetic acid, dilute with water to 1000 mL, and mix to obtain a solution having a pH of about 4.7. Mobile phase—Mix 350 mL of water, 100 mL of Buffer solution, and 550 mL of methanol. Cool to room temperature, dilute with water to 1000 mL, mix, degas, and filter. Make adjustments if necessary (see System Suitability under Chromatography <621>). Internal standard solution—Transfer a quantity of diluted nitroglycerin to a suitable volumetric flask, add about 60% of the flask volume of methanol, sonicate for 5 minutes, and shake for 30 minutes. Dilute with methanol to volume to obtain a solution having a concentration of about 3 mg of nitroglycerin per mL, and mix. Allow any undissolved material to settle, filter, and store the filtrate in an airtight container. Standard preparation—Transfer about 125 mg of recently mixed USP Diluted Isosorbide Dinitrate RS, accurately weighed, to a 50-mL volumetric flask, add about 30 mL of Mobile phase, shake for 30 minutes, dilute with Mobile phase to volume, and mix. Pipet 10 mL of the resulting solution into a 25-mL volumetric flask, and add 4.0 mL of Internal standard solution and 4 mL of dilute Buffer solution (1 in 10). Cool to room temperature, dilute with Mobile phase to volume, and mix to obtain a solution having a known concentration of about 0.25 mg of isosorbide dinitrate per mL, based on the quantity of USP Diluted Isosorbide Dinitrate RS weighed and the labeled content of isosorbide dinitrate. Pass a portion of this solution through a 0.45-µm filter. AND Add Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 220-nm detector and a 4-mm × 25-cm column that contains packing L1. The flow rate is about 1 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the resolution, R, between isosorbide dinitrate and nitroglycerin is not less than 2.0; and the relative standard deviation for replicate injections determined from the peak response ratios is not more than 2%. [Note—The relative retention times are about 0.75 for isosorbide dinitrate and 1.0 for nitroglycerin. The relative retention times for isosorbide mononitrates, if present, are about 0.38.] AND Line 1 of Procedure: Change Proceed as directed for Procedure in the Assay under Diluted Isosorbide Dinitrate. to: Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.
|
ONDANSETRON INJECTION |
Assay |
Second Supplement to USP36–NF31
|
Online |
28-Mar-2014 |
1-Apr-2014 |
USP38–NF33
|
USP38–NF33
|
Line 7 of Procedure: Change (293.36 / 329.82)(25C / V)(rU / rS) to: (293.36 / 329.83)(25C / V)(rU / rS)
AND Line 8 of Procedure: Change 329.82 to: 329.83 |