AZITHROMYCIN |
CHEMICAL INFORMATION |
USPNF Online
|
Online |
25-Aug-2023 |
1-Sep-2023 |
NA
|
NA
|
Change 748.98 to: 749.00 AND Change 767.00 to: 767.01 AND Change 785.02 to: 785.03 |
TRIMETHOBENZAMIDE HYDROCHLORIDE |
CHEMICAL INFORMATION |
USPNF Online
|
Online |
28-Jul-2023 |
1-Aug-2023 |
NA
|
NA
|
Change N-[p-[2-(Dimethylamino)ethoxy]benzyl]-3,4,5-trimethoxy benzamide monohydrochloride to: N-[4-[2-(Dimethylamino)ethoxy]benzyl]-3,4,5-trimethoxybenzamide monohydrochloride |
ATRACURIUM BESYLATE |
CHEMICAL INFORMATION |
USPNF Online
|
Online |
27-May-2022 |
1-Jun-2022 |
NA
|
NA
|
Change 2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimeth oxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate, pentamethylene ester to: 2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate,… Read More
Change 2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimeth oxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate, pentamethylene ester to: 2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate, pentamethylene ester
|
MESO-ZEAXANTHIN |
CHEMICAL INFORMATION |
USPNF Online
|
Online |
27-Jan-2023 |
1-Jun-2023 |
NA
|
NA
|
Change (3R,3′S-meso)-Zeaxanthin to: (3R,3′S)-Zeaxanthin |
POLYETHYLENE GLYCOL STANDARDS WITH MOLECULAR WEIGHTS OF 1000, 2000, 3000, 4000, AND 6000 DALTONS (G/MOL) |
CHEMICAL INFORMATION |
USPNF Online
|
Online |
27-Jan-2023 |
1-Feb-2023 |
NA
|
NA
|
Change CAS RN®: 25332-68-3. to: CAS RN®: 25322-68-3. |
IVERMECTIN |
CHEMICAL INFORMATION |
USPNF Online
|
Online |
24-Jun-2022 |
1-Jul-2022 |
NA
|
NA
|
Change C48H74O14(Component H2B1a) 875.09 C47H72O14(Component H2B1b) 861.07 Component H2B1a: Avermectin… Read More
Change C48H74O14(Component H2B1a) 875.09 C47H72O14(Component H2B1b) 861.07 Component H2B1a: Avermectin A1a, 5-O-demethyl-22,23-dihydro-. (2aE,4E,8E)-(5′S,6S,6′R,7S,11R,13R,15S,17aR,20R,20aR,20bS)-6′-(S)-sec-Butyl-3′,4′,5′,6,6′,7,10,11,14,15,17a,20,20a,20b-tetradecahydro-20,20b-dihydroxy[11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2′-[2H]pyran]-7-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside CAS RN®: 70161-11-4. Component H2B1b: Avermectin A1a, 5-O-demethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)-. (2aE,4E,8E)-(5′S,6S,6′R,7S,11R,13R,15S,17aR,20R,20aR,20bS)-3′,4′,5′,6,6′,7,10,11,-oxospiro[11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2′[2H]pyran]-7-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside CAS RN®: 70209-81-3; UNII: 0W28CYI3TU. to: C48H74O14(Component H2B1a) 875.11 C47H72O14(Component H2B1b) 861.08 Component H2B1a: Avermectin A1a, 5-O-demethyl-22,23-dihydro-. (2aE,4E,8E)-(5’S,6S,6’R,7S,11R,13R,15S,17aR,20R,20aR,20bS)-6’-(S)-sec-Butyl-3’,4’,5’,6,6’,7,10,11,14,15,17a,20,20a,20b-tetradecahydro-20,20b-dihydroxy-5’,6,8,19-tetramethyl-17-oxospiro [11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2’-[2H]pyran]-7-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside CAS RN®: 71827-03-7; UNII: 91Y2202OUW. Component H2B1b: Avermectin A1a, 5-O-demethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)-. (2aE,4E,8E)-(5’S,6S,6’R,7S,11R,13R,15S,17aR,20R,20aR,20bS)-3’,4’,5’,6,6’,7,10,11,14,15,17a,20,20a,20b-Tetradecahydro-20,20b-dihydroxy-6’-isopropyl-5’,6,8,19-tetramethyl-17-oxospiro [11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2’-[2H]pyran]-7-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside CAS RN®: 70209-81-3; UNII: 0W28CYI3TU.
|
ROCURONIUM BROMIDE |
CHEMICAL INFORMATION |
USPNF Online
|
Online |
18-Nov-2022 |
1-Dec-2022 |
NA
|
USPNF 2023 Issue 3
|
Change 609.68 to: 609.69 |
RIFABUTIN |
CHEMICAL INFORMATION |
USPNF Online
|
Online |
27-May-2022 |
1-Jun-2022 |
NA
|
NA
|
Change 847.00 to: 847.02 AND Change (9S,12E,14S,15R,16S,17R,18R,19R,20S,21S,22E,24Z)-6,16,18,20-Tetrahydroxy-1′-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethylspiro[9,4-(epoxypentadeca[1,11,13]… Read More
Change 847.00 to: 847.02 AND Change (9S,12E,14S,15R,16S,17R,18R,19R,20S,21S,22E,24Z)-6,16,18,20-Tetrahydroxy-1′-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethylspiro[9,4-(epoxypentadeca[1,11,13]trienimino)-2H-furo[2′,3′:7,8]naphth[1,2-d]imidazole-2,4′-piperidine]-5,10,26-(3H,9H)-trione-16-acetate to: (9S,12E,14S,15R,16S,17R,18R,19R,20S,21S,22E,24Z)-6,18,20-Trihydroxy-1’-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethyl-5,10,26-trioxo-3,5,9,10-tetrahydrospiro[9,4-(epoxypentadeca[1,11,13]trienimino)-2H-furo[2’,3’:7,8]naphtho[1,2-d]imidazole-2,4’-piperidin]-16-yl acetate
|
SITAGLIPTIN PHOSPHATE |
CHEMICAL INFORMATION |
USPNF Online
|
Online |
28-Oct-2022 |
1-Nov-2022 |
NA
|
NA
|
Change 523.32 to: 523.33 AND Change (3R)-3-Amino-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl-4-(2,4,5-trifluorophenyl)butan-1-one phosphate monohydrate to: (3R)-3-Amino-1-[3-(trifluoromethyl)-… Read More
Change 523.32 to: 523.33 AND Change (3R)-3-Amino-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl-4-(2,4,5-trifluorophenyl)butan-1-one phosphate monohydrate to: (3R)-3-Amino-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-4-(2,4,5-trifluorophenyl)butan-1-one phosphate monohydrate
|
Methyl Acetate |
CHEMICAL INFORMATION |
USPNF Online
|
Online |
27-Jan-2023 |
1-Feb-2023 |
NA
|
NA
|
Change CAS RN®: 74-20-9. to: CAS RN®: 79-20-9. |
BISOPROLOL FUMARATE |
CHEMICAL INFORMATION |
USPNF Online
|
Online |
28-Apr-2023 |
1-May-2023 |
NA
|
NA
|
Change (±)-1-[[α-(2-Isoproproxyethoxy)-p-tolyl]oxy]-3-(isopropyl amino)-2-propanol fumarate (2:1) (salt) to: (±)-1-[[α-(2-Isoproproxyethoxy)-p-tolyl]oxy]-3-(isopropylamino)-2-propanol fumarate (2:1) (salt) |
METHYLNALTREXONE BROMIDE |
CHEMICAL INFORMATION |
USPNF Online
|
Online |
23-Feb-2024 |
1-Mar-2024 |
NA
|
NA
|
Correct the chemical structure |
AMMONIUM GLYCYRRHIZATE |
CHEMICAL INFORMATION |
USPNF Online
|
Online |
24-Jun-2022 |
1-Jul-2022 |
NA
|
NA
|
Change 840.08 to: 839.97 |
CALCIUM LACTATE |
CHEMICAL INFORMATION |
USPNF Online
|
Online |
31-Mar-2023 |
1-Apr-2023 |
NA
|
NA
|
Change Calcium lactate (1:2) hydrate to: Calcium lactate hydrate AND Change Calcium lactate (1:2) pentahydrate to: Calcium lactate pentahydrate |
CRANBERRY FRUIT DRY JUICE |
COMPOSITION |
USPNF Online
|
Online |
25-Aug-2023 |
1-Sep-2023 |
NA
|
NA
|
In Content of Proanthocyanidins/Standard stock solution: Change USP Procyanidin A2 RS to: USP Procyanidin A2 RS AND In Content of Proanthocyanidins/Analysis: Change Use the absorbance recorded for Standard… Read More
In Content of Proanthocyanidins/Standard stock solution: Change USP Procyanidin A2 RS to: USP Procyanidin A2 RS AND In Content of Proanthocyanidins/Analysis: Change Use the absorbance recorded for Standard solutions 1–5 to obtain a calibration curve (absorbance vs. concentration, in µg/mL, of procyanidin A2) and perform a linear regression analysis. Determine the concentration (C), in µg/mL, of total proanthocyanidins as procyanidin A2 in the Sample solution. to: Use the absorbance recorded for Standard solutions 1–5 to obtain a calibration curve (absorbance vs. concentration, in µg/mL, of procyanidin A2) and perform a linear regression analysis. Determine the concentration (C), in µg/mL, of total proanthocyanidins as procyanidin A2 in the Sample solution. AND In Content of Proanthocyanidins/Analysis: Change C = concentration of the Sample solution as procyanidin A2 from the regression line (µg/mL) to: C = concentration of the Sample solution as procyanidin A2 from the regression line (µg/mL) AND In Content of Proanthocyanidins/Acceptance criteria: Change procyanidin A2 to: procyanidin A2
|
POWDERED FORSKOHLII EXTRACT |
COMPOSITION/Content of Forskolin |
USPNF Online
|
Online |
29-Jul-2022 |
1-Aug-2022 |
NA
|
NA
|
In Chromatographic system: Change Column: 4.6-mm × 25-cm; 5-µm, 100 Å to: Column: 4.6-mm × 25-cm; 5-µm, 100 Å; packing L1 |
FORSKOHLII |
COMPOSITION/Content of Forskolin |
USPNF Online
|
Online |
29-Jul-2022 |
1-Aug-2022 |
NA
|
NA
|
In Chromatographic system: Change Column: 4.6-mm × 25-cm; 5-µm, 100 Å to: Column: 4.6-mm × 25-cm; 5-µm, 100 Å; packing L1 |
POWDERED FORSKOHLII |
COMPOSITION/Content of Forskolin |
USPNF Online
|
Online |
29-Jul-2022 |
1-Aug-2022 |
NA
|
NA
|
In Chromatographic system: Change Column: 4.6-mm × 25-cm; 5-µm, 100 Å to: Column: 4.6-mm × 25-cm; 5-µm, 100 Å; packing L1 |
ROSEMARY |
COMPOSITION/Content of Phenolic Diterpenes |
USPNF Online
|
Online |
28-Apr-2023 |
1-May-2023 |
NA
|
NA
|
In Sample solution: Change Before injection, pass through a membrane filter of 0.45-µL or finer pore size, to: Before injection, pass through a membrane filter of 0.45-µm or finer pore size, |
POWDERED ROSEMARY |
COMPOSITION/Content of Phenolic Diterpenes |
USPNF Online
|
Online |
28-Apr-2023 |
1-May-2023 |
NA
|
NA
|
In Sample solution: Change Before injection, pass through a membrane filter of 0.45-µL or finer pore size, to: Before injection, pass through a membrane filter of 0.45-µm or finer pore size, |
ROSEMARY LEAF DRY AQUEOUS EXTRACT |
COMPOSITION/Content of Rosmarinic Acid |
USPNF Online
|
Online |
28-Apr-2023 |
1-May-2023 |
NA
|
NA
|
In Standard solution B: Change Before injection, pass through a membrane filter of 0.45-µL or finer pore size, to: Before injection, pass through a membrane filter of 0.45-µm or finer pore size, AND In Sample solution: Change … Read More
In Standard solution B: Change Before injection, pass through a membrane filter of 0.45-µL or finer pore size, to: Before injection, pass through a membrane filter of 0.45-µm or finer pore size, AND In Sample solution: Change Before injection, pass through a membrane filter of 0.45-µL or finer pore size, to: Before injection, pass through a membrane filter of 0.45-µm or finer pore size,
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AZTEC MARIGOLD ZEAXANTHIN EXTRACT |
COMPOSITION/Procedure 4: Stereoisomeric Composition |
USPNF Online
|
Online |
27-Jan-2023 |
1-Feb-2023 |
NA
|
NA
|
In System suitability/Suitability requirements/Resolution: Change (3R,3′S meso)-zeaxanthin to: (3R,3′S)-zeaxanthin AND In Analysis: Change (3R,3′S … Read More
In System suitability/Suitability requirements/Resolution: Change (3R,3′S meso)-zeaxanthin to: (3R,3′S)-zeaxanthin AND In Analysis: Change (3R,3′S meso)-zeaxanthin to: (3R,3′S)-zeaxanthin AND In Acceptance criteria: Change (3R,3′S meso)-Zeaxanthin to: (3R,3′S)-Zeaxanthin
|
MESO-ZEAXANTHIN PREPARATION |
COMPOSITION/Stereoisomeric Composition |
USPNF Online
|
Online |
27-Jan-2023 |
1-Feb-2023 |
NA
|
NA
|
In System suitability: Change [Note—The approximate relative retention times for (3S,3′S)-zeaxanthin, (3R,3′S-meso)-zeaxanthin, (3R,3′R)-zeaxanthin, and (3R,3′R,6′R)-lutein are 0.94… Read More
In System suitability: Change [Note—The approximate relative retention times for (3S,3′S)-zeaxanthin, (3R,3′S-meso)-zeaxanthin, (3R,3′R)-zeaxanthin, and (3R,3′R,6′R)-lutein are 0.94, 1.00, 1.06, and 1.11, respectively.] to: [Note—The approximate relative retention times for (3S,3′S)-zeaxanthin, (3R,3′S)-zeaxanthin, (3R,3′R)-zeaxanthin, and (3R,3′R,6′R)-lutein are 0.94, 1.00, 1.06, and 1.11, respectively.] AND In System suitability/Suitability requirements/Resolution: Change (3R,3′S-meso)-zeaxanthin to: (3R,3′S)-zeaxanthin AND In Analysis: Change (3R,3′S-meso)-zeaxanthin to: (3R,3′S)-zeaxanthin AND In Acceptance criteria: Change (3R,3′S-meso)-Zeaxanthin to: (3R,3′S)-Zeaxanthin
|
MESO-ZEAXANTHIN |
COMPOSITION/Stereoisomeric Composition |
USPNF Online
|
Online |
27-Jan-2023 |
1-Jun-2023 |
NA
|
NA
|
In System suitability: Change [Note—The approximate relative retention times for (3S,3′S)-zeaxanthin, (3R,3′S-meso)-zeaxanthin, (3R,3′R)-zeaxanthin, and (3R,3′R,6′R)-lutein are 0.94… Read More
In System suitability: Change [Note—The approximate relative retention times for (3S,3′S)-zeaxanthin, (3R,3′S-meso)-zeaxanthin, (3R,3′R)-zeaxanthin, and (3R,3′R,6′R)-lutein are 0.94, 1.00, 1.06, and 1.11, respectively.] to: [Note—The approximate relative retention times for (3S,3′S)-zeaxanthin, (3R,3′S)-zeaxanthin, (3R,3′R)-zeaxanthin, and (3R,3′R,6′R)-lutein are 0.94, 1.00, 1.06, and 1.11, respectively.] AND In System suitability/Suitability requirements/Resolution: Change (3R,3′S-meso)-zeaxanthin to: (3R,3′S)-zeaxanthin AND In Analysis: Change (3R,3′S-meso)-zeaxanthin to: (3R,3′S)-zeaxanthin AND In Acceptance criteria: Change (3R,3′S-meso)-Zeaxanthin to: (3R,3′S)-Zeaxanthin
|
BLACK CUMIN SEED THYMOQUINONE OIL |
DEFINITION |
USPNF Online
|
Online |
25-Aug-2023 |
1-Sep-2023 |
NA
|
NA
|
Change carvacol to: carvacrol |
LIDOCAINE, RACEPINEPHRINE AND TETRACAINE HYDROCHLORIDES COMPOUNDED TOPICAL GEL |
DEFINITION |
USPNF Online
|
Online |
29-Mar-2024 |
1-Apr-2024 |
NA
|
NA
|
Change Prepare Lidocaine, Racepinephrine, and Tetracaine Hydrochlorides Compounded Topical Gel containing 40 mg/mL of lidocaine hydrochloride, 1 mg/mL of racepinephrine hydrochloride, and 10 mg/mL of tetracaine hydrochloride as follows (see Pharmaceutical… Read More
Change Prepare Lidocaine, Racepinephrine, and Tetracaine Hydrochlorides Compounded Topical Gel containing 40 mg/mL of lidocaine hydrochloride, 1 mg/mL of racepinephrine hydrochloride, and 10 mg/mL of tetracaine hydrochloride as follows (see Pharmaceutical Compounding—Sterile Preparations <797>). to: Prepare Lidocaine, Racepinephrine, and Tetracaine Hydrochlorides Compounded Topical Gel containing 40 mg/mL of lidocaine hydrochloride, 1 mg/mL of racepinephrine hydrochloride, and 10 mg/mL of tetracaine hydrochloride as follows (see Pharmaceutical Compounding—Nonsterile Preparations <795>).
|
CRANBERRY FRUIT DRY JUICE |
DEFINITION |
USPNF Online
|
Online |
25-Aug-2023 |
1-Sep-2023 |
NA
|
NA
|
Change procyanidin A2 to: procyanidin A2 |
IRINOTECAN HYDROCHLORIDE INJECTION |
DEFINITION |
USPNF Online
|
Online |
26-Aug-2022 |
1-Sep-2022 |
NA
|
NA
|
Change NTL 90.0% and NMT 110.0% to: NLT 90.0% and NMT 110.0% |
ANETHOLE |
DEFINITION |
USPNF Online
|
Online |
28-Oct-2022 |
1-Nov-2022 |
NA
|
NA
|
Change (E)-1-methyl-4-(1-propenyl) benzene to: (E)-1-methoxy-4-(1-propenyl) benzene |
<659> PACKAGING AND STORAGE REQUIREMENTS |
GENERAL DEFINITIONS/Packaging Definitions |
Second Supplement to USP43–NF38
|
Online |
26-Mar-2021 |
1-Dec-2025 |
NA
|
NA
|
In Light-resistant container: Change 〈661.2〉, Functionality, Spectral Transmission Requirements for Light-Resistant Components and Systems. to: 〈661.2〉, Functionality Test Method, Spectral Transmission Requirements for Light-… Read More
In Light-resistant container: Change 〈661.2〉, Functionality, Spectral Transmission Requirements for Light-Resistant Components and Systems. to: 〈661.2〉, Functionality Test Method, Spectral Transmission Requirements for Light-Resistant Components and Systems.
|
<430> PARTICLE SIZE ANALYSIS BY DYNAMIC LIGHT SCATTERING |
GLOSSARY |
USPNF Online
|
Online |
27-Oct-2023 |
1-May-2024 |
NA
|
NA
|
In Average particle diameter: Change expressed in nanometers. to: expressed in meters. AND In Viscosity: Change in millipascal-seconds (mPa・s). to: in pascal-seconds (Pa・s). |
OCTOCRYLENE |
IDENTIFICATION |
USPNF Online
|
Online |
25-Aug-2023 |
1-Sep-2023 |
NA
|
NA
|
In A./Acceptance criteria: Change NMT 3.0%, calculated on the as-is basis to: Absorptivities, calculated on the as-is basis, do not differ by more than 3.0%. |
AMOXICILLIN ORAL SUSPENSION |
IDENTIFICATION |
USPNF Online
|
Online |
26-Jan-2024 |
1-Feb-2024 |
NA
|
NA
|
Change Shake a portion of Oral Suspension with a mixture of acetone and 0.1 N hydrochloric acid (4:1) to obtain a solution containing about 1 mg of amoxicillin per mL. The solution responds to the Identification test under Amoxicillin Capsules.… Read More
Change Shake a portion of Oral Suspension with a mixture of acetone and 0.1 N hydrochloric acid (4:1) to obtain a solution containing about 1 mg of amoxicillin per mL. The solution responds to the Identification test under Amoxicillin Capsules. to: Prepare a test solution by shaking a portion of Oral Suspension with a mixture of acetone and 0.1 N hydrochloric acid (4:1) to obtain a solution containing about 1 mg of amoxicillin per mL. Prepare a Standard solution of USP Amoxicillin RS in 0.1 N hydrochloric acid containing 1 mg per mL. Use within 10 minutes after preparation. Apply separately 5 µL of each solution on a thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture (see Chromatography 〈621〉). Place the plate in a suitable chromatographic chamber, and develop the chromatogram in a solvent system consisting of a mixture of methanol, chloroform, water, and pyridine (90:80:30:10). When the solvent front has moved about three-fourths of the length of the plate, remove the plate from the chamber, and dry with warm air for 10 minutes. Locate the spots on the plate by spraying lightly with a solution of ninhydrin in alcohol containing 3 mg per mL, and dry at 110° for 15 minutes: the RF value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.
|
AMANTADINE HYDROCHLORIDE |
IDENTIFICATION |
USPNF Online
|
Online |
25-Aug-2023 |
1-Sep-2023 |
NA
|
NA
|
In A.: Change Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197A, 197K, and 197S to: Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197A, 197K, or 197S Procedure for… Read More
In A.: Change Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197A, 197K, and 197S to: Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197A, 197K, or 197S Procedure for 197S
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CALCIUM L-5-METHYLTETRAHYDROFOLATE |
IDENTIFICATION |
USPNF Online
|
Online |
28-Oct-2022 |
1-Nov-2022 |
NA
|
NA
|
In A. Spectroscopic Identification Tests <197>, Infrared Spectroscopy: 197K: Change USP Calcium DL-5-Methyltetrahydrofolate RS to: USP Calcium D,L-5-Methyltetrahydrofolate RS |
DICYCLOMINE HYDROCHLORIDE |
IDENTIFICATION |
USPNF Online
|
Online |
26-Jan-2024 |
1-Feb-2024 |
NA
|
NA
|
In B. Identification Tests—General 〈191〉, Chemical Identification Tests, Chloride: Change Meets the requirements when tested as specified in test B. to: Meets the requirements of the test for amine… Read More
In B. Identification Tests—General 〈191〉, Chemical Identification Tests, Chloride: Change Meets the requirements when tested as specified in test B. to: Meets the requirements of the test for amine hydrochlorides
|
POLYETHYLENE GLYCOL 12 CETOSTEARYL ETHER |
IDENTIFICATION |
USPNF Online
|
Online |
28-Apr-2023 |
1-Aug-2023 |
NA
|
NA
|
Change: B. Test for Hydroxyl Group: to: B. Hydroxyl Value: AND In D./Analysis: Change Dissolve or disperse the Sample in alcohol. to: Dissolve or disperse the … Read More
Change: B. Test for Hydroxyl Group: to: B. Hydroxyl Value: AND In D./Analysis: Change Dissolve or disperse the Sample in alcohol. to: Dissolve or disperse the Sample in 5 mL alcohol.
|
AMOXICILLIN BOLUSES |
IDENTIFICATION |
USPNF Online
|
Online |
17-Nov-2023 |
1-Dec-2023 |
NA
|
NA
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Change Application volume, Developing solvent system, Procedure—Proceed as directed for the Identification test under Amoxicillin Tablets. to: Application volume—5 µL. Developing solvent system… Read More
Change Application volume, Developing solvent system, Procedure—Proceed as directed for the Identification test under Amoxicillin Tablets. to: Application volume—5 µL. Developing solvent system—a mixture of methanol, chloroform, water, and pyridine (90:80:30:10). Procedure—Proceed as directed in Thin-Layer Chromatographic Identification Test <201>. Dry the plate with the aid of a current of warm air for 10 minutes. Locate the spots on the plate by spraying lightly with a solution of ninhydrin in alcohol containing 3 mg per mL, and dry at 110° for 15 minutes.
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DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES |
IDENTIFICATION |
USPNF Online
|
Online |
28-Apr-2023 |
1-May-2023 |
NA
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NA
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Change A. The UV-Vis spectrum of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. to: A. The UV spectrum of the major peak of the Sample solution… Read More
Change A. The UV-Vis spectrum of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. to: A. The UV spectrum of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
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AMOXICILLIN INTRAMAMMARY INFUSION |
IDENTIFICATION |
USPNF Online
|
Online |
17-Nov-2023 |
1-Dec-2023 |
NA
|
NA
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Change The solution obtained responds to the Identification test under Amoxicillin Capsules. to: Prepare a Standard solution of USP Amoxicillin RS in 0.1 N hydrochloric acid containing 4 mg per mL. Use within 10 minutes after preparation.… Read More
Change The solution obtained responds to the Identification test under Amoxicillin Capsules. to: Prepare a Standard solution of USP Amoxicillin RS in 0.1 N hydrochloric acid containing 4 mg per mL. Use within 10 minutes after preparation. Apply separately 5 µL of each solution on a thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture (see Chromatography <621>). Place the plate in a suitable chromatographic chamber, and develop the chromatogram in a solvent system consisting of a mixture of methanol, chloroform, water, and pyridine (90:80:30:10). When the solvent front has moved about three-fourths of the length of the plate, remove the plate from the chamber, and dry with warm air for 10 minutes. Locate the spots on the plate by spraying lightly with a solution of ninhydrin in alcohol containing 3 mg per mL, and dry at 110° for 15 minutes: the RF value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.
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THEOPHYLLINE CAPSULES |
IDENTIFICATION |
USPNF Online
|
Online |
26-Jan-2024 |
1-Feb-2024 |
NA
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NA
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Change A: The contents of the Capsules respond to Identification tests A and B under Theophylline Tablets. B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds… Read More
Change A: The contents of the Capsules respond to Identification tests A and B under Theophylline Tablets. B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay. to: A: Triturate a quantity of the contents of Capsules, equivalent to about 500 mg of theophylline, with 10-mL and 5-mL portions of solvent hexane, and discard the solvent hexane. Triturate the residue with two 10-mL portions of a mixture of equal volumes of 6 N ammonium hydroxide and water, and filter each time. Evaporate the combined filtrates to about 5 mL, neutralize, if necessary, with 6 N acetic acid, using litmus, and then cool to about 15°, with stirring. Collect the precipitate on a filter, wash it with cold water, and dry at 105° for 2 hours: the theophylline so obtained melts between 270° and 274° (see Melting Range or Temperature 〈741〉, Procedures, Procedure for Class I). Retain the remaining portion of the theophylline for use in Identification test B. B: The IR absorption spectrum of a potassium bromide dispersion of the residue obtained in Identification test A exhibits maxima only at the same wavenumbers as that of a potassium bromide dispersion of USP Theophylline RS. C: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
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PENICILLIN G BENZATHINE INJECTABLE SUSPENSION |
IDENTIFICATION |
USPNF Online
|
Online |
18-Nov-2022 |
1-Dec-2022 |
NA
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NA
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Change It responds to the Identification test under Penicillin G Benzathine Oral Suspension. to: Mix a portion of it with methanol to obtain a solution containing about 3000 Penicillin G Units per mL. Apply 20 µL of this test solution and… Read More
Change It responds to the Identification test under Penicillin G Benzathine Oral Suspension. to: Mix a portion of it with methanol to obtain a solution containing about 3000 Penicillin G Units per mL. Apply 20 µL of this test solution and 20 µL of a Standard solution of USP Penicillin G Benzathine RS in methanol containing 2.5 mg per mL to a suitable thin-layer chromatographic plate (see Chromatography 〈621〉) coated with a 0.25-mm layer of chromatographic silica gel, and allow the spots to dry. Using an unlined developing chamber, develop the chromatogram in a solvent system consisting of a mixture of methanol, acetonitrile, and ammonium hydroxide (70:30:3) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, and allow to air-dry. Spray the plate uniformly with a spray reagent prepared as follows. Dissolve 20 g of tartaric acid and 1.7 g of bismuth subnitrate in 80 mL of water. Add 2.5 mL of this solution, 2.5 mL of potassium iodide solution (4 in 10), and 10 g of tartaric acid to 50 mL of water, and mix. Examine the chromatograms: the principal spot obtained from the test solution corresponds in RF value to that obtained from the Standard solution.
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PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE INJECTABLE SUSPENSION |
IDENTIFICATION |
USPNF Online
|
Online |
18-Nov-2022 |
1-Dec-2022 |
NA
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NA
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In Test A: Change It responds to the Identification test under Penicillin G Benzathine Oral Suspension: the spot obtained from the test solution, corresponding in RF value to that obtained from the Standard solution, is… Read More
In Test A: Change It responds to the Identification test under Penicillin G Benzathine Oral Suspension: the spot obtained from the test solution, corresponding in RF value to that obtained from the Standard solution, is completely resolved from a second spot, produced by penicillin G procaine. to: Mix a portion of it with methanol to obtain a solution containing about 3000 Penicillin G Units per mL. Apply 20 µL of this test solution and 20 µL of a Standard solution of USP Penicillin G Benzathine RS in methanol containing 2.5 mg per mL to a suitable thin-layer chromatographic plate (see Chromatography 〈621〉) coated with a 0.25-mm layer of chromatographic silica gel, and allow the spots to dry. Using an unlined developing chamber, develop the chromatogram in a solvent system consisting of a mixture of methanol, acetonitrile, and ammonium hydroxide (70:30:3) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, and allow to air-dry. Spray the plate uniformly with a spray reagent prepared as follows. Dissolve 20 g of tartaric acid and 1.7 g of bismuth subnitrate in 80 mL of water. Add 2.5 mL of this solution, 2.5 mL of potassium iodide solution (4 in 10), and 10 g of tartaric acid to 50 mL of water, and mix. Examine the chromatograms: the principal spot obtained from the test solution corresponds in RF value to that obtained from the Standard solution. The spot obtained from the test solution, corresponding in RF value to that obtained from the Standard solution, is completely resolved from a second spot, produced by penicillin G procaine.
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CRANBERRY FRUIT DRY JUICE |
IDENTIFICATION |
USPNF Online
|
Online |
25-Aug-2023 |
1-Sep-2023 |
NA
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NA
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In A./Standard solution B: Change USP Procyanidin A2 RS to: USP Procyanidin A2 RS AND In A./System suitability/Suitability requirements/Derivatization reagent B/White light… Read More
In A./Standard solution B: Change USP Procyanidin A2 RS to: USP Procyanidin A2 RS AND In A./System suitability/Suitability requirements/Derivatization reagent B/White light: Change Standard solution B exhibits two brown bands in the upper-half section corresponding to procyanidin A2 and epicatechin. Standard solution C exhibits two brown bands in the upper-half section corresponding in RF and color to procyanidin A2 and epicatechin in Standard solution B. Standard solution C also exhibits a series of faint or indistinct brown bands of differing intensities below procyanidin A2 in the lower-half section. to: Standard solution B exhibits two brown bands in the upper-half section corresponding to procyanidin A2 and epicatechin. Standard solution C exhibits two brown bands in the upper-half section corresponding in RF and color to procyanidin A2 and epicatechin in Standard solution B. Standard solution C also exhibits a series of faint or indistinct brown bands of differing intensities below procyanidin A2 in the lower-half section. AND In A./Acceptance criteria/Derivatization reagent B/White light: Change The Sample solution exhibits two faint brown bands corresponding in RF to procyanidin A2 and epicatechin in Standard solution B. The Sample solution also exhibits a series of faint or indistinct brown bands of differing intensities in the lower-half section, corresponding to the same bands in Standard solution C. No bands corresponding in RF to epigallocatechin-3-O-gallate, procyanidin B2, or procyanidin B1 appear below procyanidin A2. to: The Sample solution exhibits two faint brown bands corresponding in RF to procyanidin A2 and epicatechin in Standard solution B. The Sample solution also exhibits a series of faint or indistinct brown bands of differing intensities in the lower-half section, corresponding to the same bands in Standard solution C. No bands corresponding in RF to epigallocatechin-3-O-gallate, procyanidin B2, or procyanidin B1 appear below procyanidin A2. AND In C./Acceptance criteria/Profile at 520 nm: Change cyanidin-3-O-arabinose, to: cyanidin-3-O-arabinoside, AND In C./Acceptance criteria/Profile at 520 nm: Change peonidin-3-O-arabinose to: peonidin-3-O-arabinoside
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AMOXICILLIN FOR INJECTABLE SUSPENSION |
Identification |
USPNF Online
|
Online |
27-Oct-2023 |
1-Nov-2023 |
NA
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NA
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Change Prepare a test solution containing the equivalent of 4 mg of amoxicillin per mL by adding 0.1 N hydrochloric acid to Amoxicillin for Injectable Suspension. Allow the solution to stand for 5 minutes before use: the solution responds to the Identification… Read More
Change Prepare a test solution containing the equivalent of 4 mg of amoxicillin per mL by adding 0.1 N hydrochloric acid to Amoxicillin for Injectable Suspension. Allow the solution to stand for 5 minutes before use: the solution responds to the Identification test under Amoxicillin Capsules. to: Prepare a test solution containing the equivalent of 4 mg of amoxicillin per mL by adding 0.1 N hydrochloric acid to Amoxicillin for Injectable Suspension. Allow the solution to stand for 5 minutes before use. Prepare a Standard solution of USP Amoxicillin RS in 0.1 N hydrochloric acid containing 4 mg per mL. Use within 10 minutes after preparation. Apply separately 5 µL of each solution on a thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture (see Chromatography <621>). Place the plate in a suitable chromatographic chamber, and develop the chromatogram in a solvent system consisting of a mixture of methanol, chloroform, water, and pyridine (90:80:30:10). When the solvent front has moved about three-fourths of the length of the plate, remove the plate from the chamber, and dry with warm air for 10 minutes. Locate the spots on the plate by spraying lightly with a solution of ninhydrin in alcohol containing 3 mg per mL, and dry at 110° for 15 minutes: the RF value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.
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MOMETASONE FUROATE TOPICAL SOLUTION |
IDENTIFICATION |
USPNF Online
|
Online |
18-Nov-2022 |
1-Dec-2022 |
NA
|
NA
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In test A: Change The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, both relative to the internal standard, as obtained in the Assay. to: The retention time of the major… Read More
In test A: Change The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, both relative to the internal standard, as obtained in the Assay. to: The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
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ENSULIZOLE |
IDENTIFICATION |
USPNF Online
|
Online |
29-Mar-2024 |
1-Apr-2024 |
NA
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NA
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In B.: Change The retention time of the major peak of the Sample solution exhibits maxima and minima at the same wavelengths as those of the Standard solution, as obtained in the Assay. to: The retention time of the major… Read More
In B.: Change The retention time of the major peak of the Sample solution exhibits maxima and minima at the same wavelengths as those of the Standard solution, as obtained in the Assay. to: The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
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CALCIUM ASCORBATE |
IDENTIFICATION/A. |
USPNF Online
|
Online |
26-May-2023 |
1-Aug-2023 |
NA
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NA
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Change Characteristic emission lines for calcium at 184.0, 315.9, and 317.9 nm from the Sample solution correspond to those from the Standard solution, as obtained in the Assay. to: Characteristic emission lines for calcium at 184.0,… Read More
Change Characteristic emission lines for calcium at 184.0, 315.9, and 317.9 nm from the Sample solution correspond to those from the Standard solution, as obtained in the Assay. to: Characteristic emission lines for calcium at 184.0, 315.9, and 317.9 nm from the Sample solution correspond to those from the Standard solution, as obtained in the Content of Calcium.
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METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER |
IDENTIFICATION/A. |
USPNF Online
|
Online |
30-Jun-2023 |
1-Jul-2023 |
NA
|
NA
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Change USP Methacrylic Acid and Ethyl Acrylate Copolymer (1:1) RS to: USP Methacrylic Acid and Ethyl Acrylate Copolymer (1:1) RS (USP Methacrylic Acid Copolymer Type C RS) |
ACARBOSE TABLETS |
IDENTIFICATION/B. |
USPNF Online
|
Online |
28-Apr-2023 |
1-May-2023 |
NA
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NA
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Change The spectrum obtained from the Sample solution shows IR maxima in the regions of 3500–3200, 2950–2890, 1653–1633, and 1070–1000 cm–1. to: The spectrum obtained from the sample preparation shows IR maxima in the regions of 3500–3200… Read More
Change The spectrum obtained from the Sample solution shows IR maxima in the regions of 3500–3200, 2950–2890, 1653–1633, and 1070–1000 cm–1. to: The spectrum obtained from the sample preparation shows IR maxima in the regions of 3500–3200, 2950–2890, 1653–1633, and 1070–1000 cm–1.
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