Errata - English

PDF CSV May 15, 2022 through May 15, 2024 All Errata for USP–NF How to use

Monograph Title	Section	Source Publication Sort descending	Page Number	Errata Post Date	Errata Official Date	Target Errata Print Publication	Target Online Fix Publication	Description
CANDESARTAN CILEXETIL	ASSAY/Procedure	USP36–NF31	2774	31-Jan-2014	1-Feb-2014	USP38–NF33	Second Supplement to USP37–NF32	Line 1 of Analysis: Change Titrate with 8 mL of 0.1 N to: Titrate with 0.1 N
AMITRIPTYLINE HYDROCHLORIDE TABLETS	IDENTIFICATION/A.	USP36–NF31	2464	31-May-2013	1-Jun-2013	USP37–NF32	USP37–NF32	Line 2: Change Sample solution: Nominally 0.01 mg/mL of amitriptyline hydrochloride in methanol from a suitable amount of finely powdered Tablets. Filter a portion of the solution, and use the filtrate for analysis. to: Sample stock solution: Nominally 0.1 mg/mL of… Read More AMITRIPTYLINE HYDROCHLORIDE TABLETS Line 2: Change Sample solution: Nominally 0.01 mg/mL of amitriptyline hydrochloride in methanol from a suitable amount of finely powdered Tablets. Filter a portion of the solution, and use the filtrate for analysis. to: Sample stock solution: Nominally 0.1 mg/mL of amitriptyline hydrochloride in methanol from a suitable amount of finely powdered Tablets. Filter a portion of the solution, and use the filtrate. Sample solution: Nominally 0.01 mg/mL of amitriptyline hydrochloride from Sample stock solution in methanol
POWDERED STINGING NETTLE	COMPOSITION/Content of Total Amino Acids	USP36–NF31	1606	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 1 of Reagent solution: Change Solution containing 1.00 g of ninhydrin, 1.50 g of hydrindantin, to: Solution containing 1.00 g of ninhydrin, 150 mg of hydrindantin,
STEARYL ALCOHOL	SPECIFIC TESTS/Fats and Fixed Oils, Hydroxyl Value <401>	USP36–NF31	2252	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 14 of Analysis: Change [(V_S − V_B) × N × F]/W to: [(V_B − V_S) × N × M_r]/W AND Line 15 of Analysis: Change… Read More STEARYL ALCOHOL Line 14 of Analysis: Change [(V_S − V_B) × N × F]/W to: [(V_B − V_S) × N × M_r]/W AND Line 15 of Analysis: Change V_S = volume of 1 N sodium hydroxide consumed by the sample (mL) V_B = volume of 1 N sodium hydroxide consumed by the blank test (mL) to: V_B = volume of 1 N sodium hydroxide consumed by the blank test (mL) V_S = volume of 1 N sodium hydroxide consumed by the sample (mL) AND Line 21 of Analysis: Change F = molecular weight of potassium hydroxide, 56.11 to: M_r = molecular weight of potassium hydroxide, 56.11
BOSWELLIA SERRATA EXTRACT	COMPOSITION/Content of Keto-Derivatives of β-Boswellic Acids/System suitability/Suitability requirements	USP36–NF31	1367	22-Nov-2013	1-Dec-2013	USP38–NF33	Second Supplement to USP37–NF32	Line 1 of Tailing factor: Change 11-keto-β-boswellic acid peak to: 3-acetyl-11-keto-β-boswellic acid peak
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)](r_U / r_S) to: 25,000{C/[W (100 − m − s)]}(r_U / r_S)
FOSPHENYTOIN SODIUM	USP Reference standards <11>	USP36–NF31	3679	31-May-2013	1-Jun-2013	USP37–NF32	USP37–NF32	Line 6: Change C₁₄H₁₅NO₂ to: C₁₄H₁₃NO₂
POWDERED STINGING NETTLE EXTRACT	COMPOSITION/Content of Total Amino Acids	USP36–NF31	1608	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 1 of Reagent solution: Change Solution containing 1.00 g of ninhydrin, 1.50 g of hydrindantin, to: Solution containing 1.00 g of ninhydrin, 150 mg of hydrindantin,
BUTABARBITAL SODIUM TABLETS	Identification, Infrared Absorption <197K>	USP36–NF31	2716	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 5 of Test specimen: Change Proceed as directed for Column Partition Chromatography under Chromatography <621>, packing the chromatographic tube as follows. to: Pack a chromatographic tube as follows.
ALMOND OIL	SPECIFIC TESTS/Sterol Composition	USP36–NF31	1877	22-Nov-2013	1-Dec-2013	USP38–NF33	Second Supplement to USP37–NF32	Row 9 of Table 2: Change Δ7-Stigmastenol ≥3.0% to: Δ7-Stigmastenol ≤3.0%
CLARITHROMYCIN	ASSAY/Procedure/System suitability	USP36–NF31	3016	31-Jan-2014	1-Feb-2014	USP38–NF33	Second Supplement to USP37–NF32	Line 1 of Samples: Change Standard solution 2 and Standard solution 4 to: Standard solution 1, Standard solution 2, and Standard solution 4 AND Line 13 of Suitability requirements: Change Relative standard deviation: NMT 1.… Read More CLARITHROMYCIN Line 1 of Samples: Change Standard solution 2 and Standard solution 4 to: Standard solution 1, Standard solution 2, and Standard solution 4 AND Line 13 of Suitability requirements: Change Relative standard deviation: NMT 1.5%, Standard solution 2 to: Relative standard deviation: NMT 1.5%, Standard solution 1
FOSPHENYTOIN SODIUM INJECTION	USP Reference standards <11>	USP36–NF31	3680	31-May-2013	1-Jun-2013	USP37–NF32	USP37–NF32	Line 6: Change C₁₄H₁₅NO₂ to: C₁₄H₁₃NO₂
GLYCERYL DISTEARATE	ASSAY/Procedure/Chromatographic system	USP36–NF31	2029	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 1 of Column temperature: Change Column temperature: 40° to: Temperatures Detector: 40° Column: 40°
CAFFEINE CITRATE INJECTION	Assay	USP36–NF31	2732	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 3 of Chromatographic system: Change 150-cm column to: 15-cm column
POLYETHYLENE GLYCOL MONOMETHYL ETHER	IMPURITIES/Limit of 2-Methoxyethanol	USP36–NF31	2142	22-Nov-2013	1-Dec-2013	USP38–NF33	Second Supplement to USP37–NF32	Line 11 of Calibration: Change On the two Calibration plots, to: On the Calibration plot,
DICLOFENAC SODIUM DELAYED-RELEASE TABLETS	IMPURITIES/Organic Impurities/Procedure	USP36–NF31	3221	31-Jan-2014	1-Feb-2014	USP38–NF33	Second Supplement to USP37–NF32	Line 22 of Analysis: Change r_S = peak response for each impurity from the Standard solution to: r_S = peak response of diclofenac related compound A from the Standard solution
FOSPHENYTOIN SODIUM INJECTION	Assay	USP36–NF31	3680	31-May-2013	1-Jun-2013	USP37–NF32	USP37–NF32	Line 1 of Assay preparation: Change Transfer an accurately measured volume of the Injection, equivalent to about 300 mg of fosphenytoin, to: Transfer an accurately measured volume of the Injection, equivalent to about 300 mg of fosphenytoin sodium,
SODIUM HYDROXIDE	ASSAY/Procedure	USP36–NF31	2203	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 11 of Analysis: Change = volume of Titrant consumed by the Sample to the first endpoint (mL) to: = volume of Titrant consumed by the Sample to the second endpoint (mL)
<232> ELEMENTAL IMPURITIES—LIMITS	DRUG PRODUCTS/Options for Demonstrating Compliance	USP36–NF31	151	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 17 of Summation Option: Change the manufacturer must validate to: the manufacturer must ensure
CAFFEINE CITRATE ORAL SOLUTION	Assay	USP36–NF31	2733	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 3 of Chromatographic system: Change 150-cm column to: 15-cm column
FERRIC AMMONIUM CITRATE	Mercury	USP36–NF31	2469	22-Nov-2013	1-Dec-2013	USP38–NF33	Second Supplement to USP37–NF32	Line 5 of Standard solutions: Change 2.5, 5.0, 10.0, and 35.0 µg to: 2.5, 5.0, 10.0, and 35.0 ng
DILTIAZEM HYDROCHLORIDE	IMPURITIES/Organic Impurities	USP36–NF31	3258	31-Jan-2014	1-Feb-2014	USP38–NF33	Second Supplement to USP37–NF32	Line 21 of Analysis: Change r_S = response of each impurity peak from the Standard solution to: r_S = peak response of desacetyl diltiazem from the Standard solution
MINOCYCLINE HYDROCHLORIDE CAPSULES	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 MINOCYCLINE HYDROCHLORIDE CAPSULES 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.
AMOXICILLIN	IMPURITIES/Organic Impurities/Procedure	USP36–NF31	2477	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 2 of Acceptance criteria: Change [Note—The reporting limit is 0.03% of the amoxicillin peak from the Standard solution. ] to: [Note—The reporting limit is 0.03 times the amoxicillin peak from the Standard solution. ]
<232> ELEMENTAL IMPURITIES—LIMITS	ANALYTICAL TESTING	USP36–NF31	151	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 2: Change If, by validated processes and supply-chain control, to: If, by process monitoring and supply-chain control,
CARISOPRODOL, ASPIRIN, AND CODEINE PHOSPHATE TABLETS	USP Reference standards <11>	USP36–NF31	2813	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 2 of USP Codeine N-Oxide RS: Change C₁₈H₂₁O₄ to: C₁₈H₂₁NO₄
APROTININ	Limit of des-Ala-aprotinin and des-Ala-des-Gly-aprotinin	USP36–NF31	2522	22-Nov-2013	1-Dec-2013	USP38–NF33	Second Supplement to USP37–NF32	Change the subsection head Capillary zone electrophoresis system (see Capillary Electrophoresis under Biotechnology-Derived Articles—Test <1047>)— to: Capillary zone electrophoresis system—
FENTANYL	IMPURITIES/Organic Impurities/Acceptance criteria	USP36–NF31	3554	31-Jan-2014	1-Feb-2014	USP38–NF33	Second Supplement to USP37–NF32	Footnote f of Table 2: Change N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]acetanilide hydrochloride, or acetyl fentanyl. to: N-(1-Phenethylpiperidin-4-yl)-N-phenylacetamide.
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 MINOCYCLINE FOR INJECTION 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.
BETAMETHASONE SODIUM PHOSPHATE	Identification/B. Thin-Layer Chromatographic Identification Test <201>	USP36–NF31	2645	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 1 of Test solution: Change 1 mg per mL. to: 1 mg per mL in methanol.
ACETYLTRIBUTYL CITRATE	IDENTIFICATION/B.	USP36–NF31	1869	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 2: Change USP Acetyltriethyl Citrate RS to: USP Acetyltributyl Citrate RS
CLAVULANATE POTASSIUM	IMPURITIES/Organic Impurities/Procedure 3: Limit of Aliphatic Amines	USP36–NF31	3022	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	In the definition list in Analysis: Change C_U = nominal concentration of Clavulanate Potassium in the Standard solution to: C_U = nominal concentration of Clavulanate Potassium in the Sample solution
CARVEDILOL	IMPURITIES/Organic Impurities, Procedure 3: Carvedilol Related Compound F	USP36–NF31	2822	22-Nov-2013	1-Dec-2013	USP38–NF33	Second Supplement to USP37–NF32	Line 2 of Sample solution: Change Use about 1.9 mL of Diluent per mg of the Carvedilol, and sonicate briefly to facilitate dissolution. to: Initially add Diluent to fill about 80% of the total volume. Sonicate briefly to facilitate dissolution. Cool, and dilute with… Read More CARVEDILOL Line 2 of Sample solution: Change Use about 1.9 mL of Diluent per mg of the Carvedilol, and sonicate briefly to facilitate dissolution. to: Initially add Diluent to fill about 80% of the total volume. Sonicate briefly to facilitate dissolution. Cool, and dilute with Diluent to volume.
RIBOFLAVIN 5′-PHOSPHATE SODIUM	IMPURITIES/Free Riboflavin and Riboflavin Diphosphates	USP36–NF31	5037	31-Jan-2014	1-Feb-2014	USP38–NF33	Second Supplement to USP37–NF32	Line 1 of Emission wavelength: Change 530 nm to: 530 nm (monochromator-based detector) or 470 nm (filtered-type detector)
Metronidazole	ASSAY	USP36–NF31	4352	30-Nov-2012	1-Dec-2012	USP37–NF32	Second Supplement to USP36–NF31	Line 8 of Chromatogaphic system: Add new subsection after Injection volume: Run time: Twice the retention time of metronidazole
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 MINOCYCLINE HYDROCHLORIDE ORAL SUSPENSION 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.
CALCIUM CARBONATE	IMPURITIES	USP36–NF31	2747	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Line 1 of Acceptance criteria in Limit of Fluoride: Change 50 ppm to: NMT 50 ppm AND Line 1 of Acceptance criteria in Mercury, Method IIa <261>: Change 0.5 ppm to: NMT 0.5 ppm
DILUTED ALCOHOL	ADDITIONAL REQUIREMENTS	USP36–NF31	1874	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Delete USP Reference Standards <11> section
DROSPIRENONE	IMPURITIES/Organic Impurities/Procedure 2	USP36–NF31	3349	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	In footnote b of Table 4: Change 5β,17β-Dihydroxy-6β,7β:15β,16β-dimethylene-17α-pregnan-21-carboxylic acid, γ-lactone. to: 5β,17-Dihydroxy-6β,7β:15β,16β-dimethylene-3-oxo-17α-pregnan-21-carboxylic acid, γ-lactone.
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
RISPERIDONE TABLETS	Dissolution <711>	USP36–NF31	5065	31-Jan-2014	1-Feb-2014	USP38–NF33	Second Supplement to USP37–NF32	Line 4 of Chromatographic system: Change Chromatograph the Standard solution and the Test solution as directed for Procedure: to: Chromatograph the Standard solution as directed for Procedure:
<1079> GOOD STORAGE AND DISTRIBUTION PRACTICES FOR DRUG PRODUCTS	QUALITY MANAGEMENT SYSTEM/Storage Management System/Receiving and Transferring Drug Products	USP36–NF31	693	29-Mar-2013	1-Apr-2013	USP37–NF32	USP37–NF32	Line 1 of footnote 1: Change JP Edmond, to: JP Emond,
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 MINOCYCLINE HYDROCHLORIDE TABLETS 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.
CEFDINIR CAPSULES	IMPURITIES/Organic Impurities/Table 2	USP36–NF31	2850	26-Jul-2013	1-Aug-2013	USP38–NF33	First Supplement to USP37–NF32	Row 16 of Column 1: Change Cefdinir impurity 2^e to: Cefdinir impurity 2^f AND Row 21 of Column 1: Change Cefdinir impurity 3^e to: Cefdinir impurity 3^f
BEHENOYL POLYOXYLGLYCERIDES	IMPURITIES/Limit of Free Glycerol/Titrimetric system	USP36–NF31	1892	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 1 of Mode: Change Direct titration to: Residual titration
ESOMEPRAZOLE MAGNESIUM	SPECIFIC TESTS/Color of Solution	USP36–NF31	3464	27-Sep-2013	1-Oct-2013	USP38–NF33	First Supplement to USP37–NF32	Line 1 of Sample solution: Change 20 mg/mL of Esomeprazole Magnesium in methanol to: 20 mg/mL of Esomeprazole Magnesium in methanol, filtered
GADOTERIDOL INJECTION	Bacterial endotoxins <85>	USP36–NF31	3701	22-Nov-2013	1-Dec-2013	USP38–NF33	Second Supplement to USP37–NF32	Line 2: Change gadoteridol. to: Gadoteridol Injection.
TIZANIDINE TABLETS	IMPURITIES/Organic Impurities/Procedure	USP36–NF31	5408	31-Jan-2014	1-Feb-2014	USP38–NF33	Second Supplement to USP37–NF32	Line 9 of Sample solution: Change 45-µm or finer pore size to: 0.45-µm or finer pore size
POWDERED BLACK PEPPER EXTRACT	DEFINITION	USP36–NF31	1365	29-Mar-2013	1-Apr-2013	USP37–NF32	USP37–NF32	Line 5: Change It contains NLT 90.0% and NMT 110.0% of the labeled amount of piperine. to: It contains NLT 90.0% and NMT 110.0% of the labeled amount of piperine, calculated on the dried basis.
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,