Errata - English

PDF CSV October 18, 2023 through October 18, 2025 All Errata for USP–NF How to use

Monograph Title	Section	Source Publication	Page Number	Errata Post Date Sort ascending	Errata Official Date	Target Errata Print Publication	Target Online Fix Publication	Description
BROMPHENIRAMINE MALEATE	SPECIFIC TESTS/Optical Rotation, Specific Rotation <781>	USP38–NF33	2475	25-Sep-2015	1-Oct-2015	USP40–NF35	First Supplement to USP39–NF34	Line 1: Delete Specific Rotation AND Line 1 of Sample: Change 100 mg/mL in water to: 100 mg/mL in water at 20°
CALCIUM LACTATE TABLETS	ASSAY/Procedure	USP38–NF33	2553	25-Sep-2015	1-Oct-2015	USP40–NF35	First Supplement to USP39–NF34	Line 3 of Analysis: Change While stirring, add 30 mL of Titrant from a 50-mL buret. to: While stirring, add 15 mL of Titrant from a 50-mL buret.
CHLOROXYLENOL	IMPURITIES/Limit of Tetrachloroethylene	USP38–NF33	2774	25-Sep-2015	1-Oct-2015	USP40–NF35	First Supplement to USP39–NF34	Row 3 of Column 1 of Table 2: Change 210 to: 70 Row 3 of Column 2 of Table 2: Change 0 to: 35
ETHOTOIN	Related compounds/Procedure	USP38–NF33	3415	25-Sep-2015	1-Oct-2015	USP40–NF35	First Supplement to USP39–NF34	Line 11:Change weight, in mg, on the anhydrous basis, of the portion of Ethotoin taken; to: weight, in mg, of the portion of Ethotoin taken;
HYDROXYZINE PAMOATE ORAL SUSPENSION	ADDITIONAL REQUIREMENTS/USP Reference Standards <11>	USP38–NF33	3817	25-Sep-2015	1-Oct-2015	USP40–NF35	First Supplement to USP39–NF34	Delete USP Hydroxyzine Hydrochloride RS
IPRATROPIUM BROMIDE	DEFINITION	USP38–NF33	3932	25-Sep-2015	1-Oct-2015	USP40–NF35	First Supplement to USP39–NF34	Line 2: Change (C₂₀H₃₀BrNO₃ · H₂O) to: (C₂₀H₃₀BrNO₃)
IPRATROPIUM BROMIDE	ASSAY/Procedure	USP38–NF33	3932	25-Sep-2015	1-Oct-2015	USP40–NF35	First Supplement to USP39–NF34	Line 4 of Analysis: Change (C₂₀H₃₀BrNO₃ · H₂O) to: (C₂₀H₃₀BrNO₃)
METHOHEXITAL	CHEMICAL INFORMATION	USP38–NF33	4316	25-Sep-2015	1-Oct-2015	USP40–NF35	First Supplement to USP39–NF34	Line 5: Change [18652-93-2] to: [151-83-7]
NALOXONE HYDROCHLORIDE	IMPURITIES/Noroxymorphone Hydrochloride [(−)-4,5α-Epoxy-3,14-Dihydroxymorphinan-6-one-hydrochloride] and Other Impurities/Chromatographic system	USP38–NF33	4486	25-Sep-2015	1-Oct-2015	USP40–NF35	First Supplement to USP39–NF34	Add Application volume: 5 µL
NOREPINEPHRINE BITARTRATE	CHEMICAL INFORMATION	USP38–NF33	4582	25-Sep-2015	1-Oct-2015	USP40–NF35	First Supplement to USP39–NF34	Line 6: Change [69815-49-2]. to: [108341-18-0].
OXAZEPAM	SPECIFIC TESTS/pH <791>	USP38–NF33	4683	25-Sep-2015	1-Oct-2015	USP40–NF35	First Supplement to USP39–NF34	Line 1: Change Sample solution: 20 mg/mL to: Sample: A suspension of 1 g of Oxazepam in 50 mL water
RIBAVIRIN TABLETS	IMPURITIES/Organic Impurities, Procedure 1	USP38–NF33	5162	25-Sep-2015	1-Oct-2015	USP40–NF35	First Supplement to USP39–NF34	Footnote e of Table 2: Change 1-β-D-Ribofuranosyl-1H-1,2,4-triazole-3-carboxamide. to: 1-β-D-Ribofuranosyl-1H-1,2,4-triazole-5-carboxamide.
RIVASTIGMINE	ADDITIONAL REQUIREMENTS/USP Reference Standards <11>	USP38–NF33	5212	25-Sep-2015	1-Oct-2015	USP40–NF35	First Supplement to USP39–NF34	Line 2 of USP Rivastigmine Related Compound B RS: Change Nor impurity; (S)-3-[1-(Dimethylamino)ethyl]phenyl dimethylcarbamate. to: Nor impurity (racemic mixture); (RS)‐3‐[1‐(Dimethylamino)ethyl]phenyl dimethylcarbamate.
RIVASTIGMINE	IMPURITIES/Organic Impurities	USP38–NF33	5212	25-Sep-2015	1-Oct-2015	USP40–NF35	First Supplement to USP39–NF34	Row 3 of Column 1 of Table 1: Change Nor impurity (rivastigmine related compound B) to: Nor impurity^a AND Add footnote a: ^a(S)‐3‐[1‐(Dimethylamino)ethyl]phenyl dimethylcarbamate (racemic mixture is rivastigmine related compound B).
RIVASTIGMINE TARTRATE	ADDITIONAL REQUIREMENTS/USP Reference Standards <11>	USP38–NF33	5213	25-Sep-2015	1-Oct-2015	USP40–NF35	First Supplement to USP39–NF34	Line 2 of USP Rivastigmine Related Compound B RS: Change N,N-Dimethylcarbamic acid-3-[1-(dimethylamino)ethyl]phenyl ester. to: (RS)‐3‐[1‐(Dimethylamino)ethyl]phenyl dimethylcarbamate.
RIVASTIGMINE TARTRATE	IMPURITIES/Organic Impurities/Procedure 1	USP38–NF33	5213	25-Sep-2015	1-Oct-2015	USP40–NF35	First Supplement to USP39–NF34	Footnote c of Impurity Table 1: Change (S)-3-[1-(Dimethylamino)ethyl]phenyl dimethylcarbamate (rivastigmine related compound B). to: (S)‐3‐[1‐(Dimethylamino)ethyl]phenyl dimethylcarbamate (racemic mixture is rivastigmine related compound B).
RIVASTIGMINE TARTRATE CAPSULES	ADDITIONAL REQUIREMENTS/USP Reference Standards <11>	USP38–NF33	5215	25-Sep-2015	1-Oct-2015	USP40–NF35	First Supplement to USP39–NF34	Line 2 of USP Rivastigmine Related Compound B RS: Change N,N-Dimethylcarbamic acid-3-[1-(dimethylamino)ethyl]phenyl ester. to: (RS)‐3‐[1‐(Dimethylamino)ethyl]phenyl dimethylcarbamate.
ROPIVACAINE HYDROCHLORIDE	ADDITIONAL REQUIREMENTS/USP Reference Standards <11>	USP38–NF33	5225	25-Sep-2015	1-Oct-2015	USP40–NF35	First Supplement to USP39–NF34	Line 2 of USP Ropivacaine Related Compound B RS: Change (R)-ropivacaine hydrochloride monohydrate; (R)-(−)-1-propylpiperidine-2-carboxylic acid (2,6-dimethylphenyl)-amide hydrochloride monohydrate. to: (R)-Ropivacaine hydrochloride monohydrate; (R)-(+)-1-… Read More ROPIVACAINE HYDROCHLORIDE Line 2 of USP Ropivacaine Related Compound B RS: Change (R)-ropivacaine hydrochloride monohydrate; (R)-(−)-1-propylpiperidine-2-carboxylic acid (2,6-dimethylphenyl)-amide hydrochloride monohydrate. to: (R)-Ropivacaine hydrochloride monohydrate; (R)-(+)-1-propylpiperidine-2-carboxylic acid (2,6-dimethylphenyl)-amide hydrochloride monohydrate.
ROPIVACAINE HYDROCHLORIDE INJECTION	USP Reference standards <11>	USP38–NF33	5227	25-Sep-2015	1-Oct-2015	USP40–NF35	First Supplement to USP39–NF34	Line 2 of USP Ropivacaine Related Compound B RS: Change (R)-ropivacaine hydrochloride monohydrate; (R)-(−)-1-propylpiperidine-2-carboxylic acid (2,6-dimethylphenyl)-amide hydrochloride monohydrate. to: (R)-Ropivacaine hydrochloride monohydrate; (R)-(+)-1-… Read More ROPIVACAINE HYDROCHLORIDE INJECTION Line 2 of USP Ropivacaine Related Compound B RS: Change (R)-ropivacaine hydrochloride monohydrate; (R)-(−)-1-propylpiperidine-2-carboxylic acid (2,6-dimethylphenyl)-amide hydrochloride monohydrate. to: (R)-Ropivacaine hydrochloride monohydrate; (R)-(+)-1-propylpiperidine-2-carboxylic acid (2,6-dimethylphenyl)-amide hydrochloride monohydrate.
VALGANCICLOVIR HYDROCHLORIDE	Assay	USP38–NF33	5729	25-Sep-2015	1-Oct-2015	USP40–NF35	First Supplement to USP39–NF34	Line 4 of Procedure: Change Calculate the percentage, on the anhydrous and solvent-free basis, of C₁₄H₂₂N₆O₅ · HCl to: Calculate the percentage of valganciclovir hydrochloride (C₁₄H₂₂N₆O₅ · HCl… Read More VALGANCICLOVIR HYDROCHLORIDE Line 4 of Procedure: Change Calculate the percentage, on the anhydrous and solvent-free basis, of C₁₄H₂₂N₆O₅ · HCl to: Calculate the percentage of valganciclovir hydrochloride (C₁₄H₂₂N₆O₅ · HCl) AND Line 8 of Procedure: Change 100[(r_U / W_U)(C_F )(100) /(100 − S_U)] to: 100[(r_U/W_U)(C_F)(100)] AND Line 12 of Procedure: Change C_F is the correction factor; and S_U is the total percent of solvent and water in the test sample. to: and C_F is the correction factor. AND Line 16 of Procedure: Change (W_S / R_S)[(100 − S_S) /100] to: (W_S/R_S)/100 AND Line 18 of Procedure: Change R_S is the area response (sum of two peaks for valganciclovir diastereomers) obtained from the Standard preparation; and S_S is the total percent of solvent and water in USP Valganciclovir Hydrochloride RS. to: and R_S is the area response (sum of two peaks for valganciclovir diastereomers) obtained from the Standard preparation.
SODIUM STEARYL FUMARATE	SPECIFIC TESTS/Fats and Oils, Saponification Value <401>	USP38–NF33	6877	25-Sep-2015	1-Oct-2015	USP40–NF35	First Supplement to USP39–NF34	Line 6 of Analysis: Change Rinse the condenser with two 10-mL portions of 70% alcohol, add phenolphthalein TS, to: Rinse the condenser with 10 mL of 70% alcohol, followed by three 10-mL portions of water, collecting the rinsings in the flask. Cool, rinse the sides of the flask… Read More SODIUM STEARYL FUMARATE Line 6 of Analysis: Change Rinse the condenser with two 10-mL portions of 70% alcohol, add phenolphthalein TS, to: Rinse the condenser with 10 mL of 70% alcohol, followed by three 10-mL portions of water, collecting the rinsings in the flask. Cool, rinse the sides of the flask with two 10-mL portions of 70% alcohol, add phenolphthalein TS,
CHLORPHENIRAMINE MALEATE	SPECIFIC TESTS/Optical Rotation, Specific Rotation <781>	Second Supplement to USP38–NF33	Online	25-Sep-2015	1-Oct-2015	USP40–NF35	First Supplement to USP39–NF34	Line 1: Delete Specific Rotation
AMOXICILLIN TABLETS FOR ORAL SUSPENSION	ASSAY/Procedure	USP38–NF33	2225	31-Jul-2015	1-Aug-2015	USP40–NF35	First Supplement to USP39–NF34	Line 6 of Analysis: Change Result = (r_U/r_S) × (C_S/C_U) × P × (1/F) ×100 to: Result = (r_U/r_S) × (C_S/C_U) × P × F… Read More AMOXICILLIN TABLETS FOR ORAL SUSPENSION Line 6 of Analysis: Change Result = (r_U/r_S) × (C_S/C_U) × P × (1/F) ×100 to: Result = (r_U/r_S) × (C_S/C_U) × P × F × 100
ESTRADIOL AND NORETHINDRONE ACETATE TABLETS	IMPURITIES/Organic Impurities/Procedure/System suitability	USP38–NF33	3385	31-Jul-2015	1-Aug-2015	USP40–NF35	First Supplement to USP39–NF34	Line 2 of the Note: Change 1.0, 1.4, and 3.0, to: 1.0, 1.1, and 1.7,
METHOTREXATE	IMPURITIES/Organic Impurities/Procedure 1: Related Compounds	USP38–NF33	4318	31-Jul-2015	1-Aug-2015	USP40–NF35	First Supplement to USP39–NF34	Line 15 of Analysis: Change methotrexate related compound E free acid to: methotrexate related compound E free base AND Line 8 of the second variable definition list for Analysis: Change methotrexate related compound E free acid to: methotrexate related… Read More METHOTREXATE Line 15 of Analysis: Change methotrexate related compound E free acid to: methotrexate related compound E free base AND Line 8 of the second variable definition list for Analysis: Change methotrexate related compound E free acid to: methotrexate related compound E free base AND Row 5 of Column 1 of Impurity Table 1: Change Methotrexate related compound E free acid^c to: Methotrexate related compound E free base^c
METOLAZONE TABLETS	ASSAY/Procedure	USP38–NF33	4368	31-Jul-2015	1-Aug-2015	USP40–NF35	First Supplement to USP39–NF34	Change the subsection Standard solution: 5 µg/mL of USP Metolazone RS in methanol to: Standard stock solution: 0.25 mg/mL of USP Metolazone RS in methanol Standard solution: 5 µg/mL of USP Metolazone RS in Mobile phase from Standard stock solution … Read More METOLAZONE TABLETS Change the subsection Standard solution: 5 µg/mL of USP Metolazone RS in methanol to: Standard stock solution: 0.25 mg/mL of USP Metolazone RS in methanol Standard solution: 5 µg/mL of USP Metolazone RS in Mobile phase from Standard stock solution AND Line 2 of Sample solution: Change of metolazone from the Sample stock solution in methanol to: of metolazone in Mobile phase from the Sample stock solution
OXAPROZIN TABLETS	IMPURITIES/Organic Impurities/System suitability/Suitability requirements	USP38–NF33	4681	31-Jul-2015	1-Aug-2015	USP40–NF35	First Supplement to USP39–NF34	Delete the subsection Signal-to-noise ratio: NLT 3000
TETRACAINE HYDROCHLORIDE INJECTION	Identification	USP38–NF33	5507	31-Jul-2015	1-Aug-2015	USP40–NF35	First Supplement to USP39–NF34	Line 1 of A: Change It responds to Identification test B under Tetracaine Hydrochloride. to: Dissolve 100 mg in 10 mL of water, and add 1 mL of potassium thiocyanate solution (1 in 4): a crystalline precipitate is formed. Recrystallize the precipitate from… Read More TETRACAINE HYDROCHLORIDE INJECTION Line 1 of A: Change It responds to Identification test B under Tetracaine Hydrochloride. to: Dissolve 100 mg in 10 mL of water, and add 1 mL of potassium thiocyanate solution (1 in 4): a crystalline precipitate is formed. Recrystallize the precipitate from water, and dry at 80° for 2 hours: it melts between 130° and 132°.
TETRACAINE HYDROCHLORIDE FOR INJECTION	Identification	USP38–NF33	5508	31-Jul-2015	1-Aug-2015	USP40–NF35	First Supplement to USP39–NF34	Line 1 of B: Change It responds to Identification test B under Tetracaine Hydrochloride. to: Dissolve 100 mg in 10 mL of water, and add 1 mL of potassium thiocyanate solution (1 in 4): a crystalline precipitate is formed. Recrystallize the precipitate from… Read More TETRACAINE HYDROCHLORIDE FOR INJECTION Line 1 of B: Change It responds to Identification test B under Tetracaine Hydrochloride. to: Dissolve 100 mg in 10 mL of water, and add 1 mL of potassium thiocyanate solution (1 in 4): a crystalline precipitate is formed. Recrystallize the precipitate from water, and dry at 80° for 2 hours: it melts between 130° and 132°.
TETRACAINE HYDROCHLORIDE FOR INJECTION	Chromatographic purity	USP38–NF33	5508	31-Jul-2015	1-Aug-2015	USP40–NF35	First Supplement to USP39–NF34	Line 1: Change Dissolve an accurately weighed quantity of Tetracaine Hydrochloride for Injection in water to obtain a test solution containing 50 mg per mL, and proceed as directed in the test for Chromatographic purity under Tetracaine, beginning with “Prepare a Standard… Read More TETRACAINE HYDROCHLORIDE FOR INJECTION Line 1: Change Dissolve an accurately weighed quantity of Tetracaine Hydrochloride for Injection in water to obtain a test solution containing 50 mg per mL, and proceed as directed in the test for Chromatographic purity under Tetracaine, beginning with “Prepare a Standard solution.” to: Dissolve an accurately weighed quantity of Tetracaine Hydrochloride for Injection in water to obtain a test solution containing 50 mg per mL. Prepare a Standard solution of 4-(butylamino) benzoic acid in methanol containing 0.2 mg per mL. Apply separate 5-µL portions of the test solution and the Standard solution to a suitable thin-layer chromatographic plate (see Chromatography <621>) coated with a 0.25-mm layer of chromatographic silica gel mixture. Develop the plate in a suitable chromatographic chamber containing a solvent system consisting of a mixture of chloroform, methanol, and isopropylamine (98:7:2) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, and dry in a current of warm air. Examine the plate under short-wavelength UV light: any spot obtained from the test solution, other than the principal spot, is not more intense than the principal spot obtained from the Standard solution (0.4%), and the sum of the intensities of any such spots is not greater than 0.8%.
TETRACAINE HYDROCHLORIDE IN DEXTROSE INJECTION	Identification	USP38–NF33	5509	31-Jul-2015	1-Aug-2015	USP40–NF35	First Supplement to USP39–NF34	Line 1 of B: Change It responds to Identification test C under Tetracaine Hydrochloride. to: A solution of 100 mg in 5 mL of water meets the requirements of the tests for Chloride <191>.
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER	DEFINITION	USP38–NF33	6753	31-Jul-2015	1-Aug-2015	USP40–NF35	First Supplement to USP39–NF34	Line 4: Change Methacrylic acid units in Methacrylic Acid and Ethyl Acrylate Copolymer are NLT 46.0% and NMT 50.6%, calculated on the dried basis. to: Methacrylic acid units in Methacrylic Acid and Ethyl Acrylate Copolymer, previously dried, are NLT 46.0% and NMT 50.6%.
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER	ASSAY/Procedure	USP38–NF33	6753	31-Jul-2015	1-Aug-2015	USP40–NF35	First Supplement to USP39–NF34	Line 1 of Acceptance criteria: Delete on the dried basis
METHACRYLIC ACID AND METHYL METHACRYLATE COPOLYMER	DEFINITION	USP38–NF33	6755	31-Jul-2015	1-Aug-2015	USP40–NF35	First Supplement to USP39–NF34	Methacrylic acid units in Methacrylic Acid and Methyl Methacrylate Copolymer are NLT 27.6% and NMT 50.6%, calculated on the dried basis. to: Methacrylic acid units in Methacrylic Acid and Methyl Methacrylate Copolymer, previously dried, are NLT 27.6% and NMT 50.6%.
METHACRYLIC ACID AND METHYL METHACRYLATE COPOLYMER	ASSAY/Procedure	USP38–NF33	6755	31-Jul-2015	1-Aug-2015	USP40–NF35	First Supplement to USP39–NF34	Line 3 of Acceptance criteria: Delete on the dried basis AND Line 5 of Acceptance criteria: Delete on the dried basis
PURIFIED STEARIC ACID	ASSAY/Procedure/System suitability/Suitability requirements	USP38–NF33	6919	31-Jul-2015	1-Aug-2015	USP40–NF35	First Supplement to USP39–NF34	Line 2 of Relative standard deviation: Change six replicate injections of Sample solution; to: six replicate injections;
ALMOTRIPTAN MALATE	IMPURITIES/Limit of Almotriptan Related Compound D and Almotriptan N-Dimer	First Supplement to USP38–NF33	7325	31-Jul-2015	1-Aug-2015	USP40–NF35	First Supplement to USP39–NF34	Line 1of Internal standard solution: Change 4-hydroxy-phenylpiperidine to: 4-hydroxy-4-phenylpiperidine
DOXAZOSIN MESYLATE	IMPURITIES/Organic Impurities/Analysis	First Supplement to USP38–NF33	7387	31-Jul-2015	1-Aug-2015	USP40–NF35	First Supplement to USP39–NF34	Line 3 of the variable definition list: Change r_S = peak response of each impurity from the Standard solution to: r_S= peak response of each impurity or doxazosin mesylate (for calculating unspecified impurities) from the Standard solution… Read More DOXAZOSIN MESYLATE Line 3 of the variable definition list: Change r_S = peak response of each impurity from the Standard solution to: r_S= peak response of each impurity or doxazosin mesylate (for calculating unspecified impurities) from the Standard solution AND Line 5 of the variable definition list: Change C_S = concentration of USP Doxazosin Mesylate RS in the Standard solution (mg/mL) to: C_S= concentration of the corresponding USP Doxazosin Related Compound RS or USP Doxazosin Mesylate RS (for calculating unspecified impurities) in the Standard solution (mg/mL)
STEARIC ACID	ASSAY/Procedure/System suitability/Suitability requirements	Harmonization (Official May 01, 2015)	Online	31-Jul-2015	1-Aug-2015	USP40–NF35	First Supplement to USP39–NF34	Line 3 of Relative standard deviation: Change peaks (from six replicate injections of Sample solution); to: peaks, from six replicate injections;
<1056> BIOTECHNOLOGY-DERIVED ARTICLES -- POLYACRYLAMIDE GEL ELECTROPHORESIS	INTRODUCTION	Harmonization (Official December 01, 2015)	Online	31-Jul-2015	1-Aug-2015	USP40–NF35	First Supplement to USP39–NF34	A paragraph before the Introduction was deleted: This chapter provides guidance and procedures used for characterization of biotechnology-derived articles by polyacrylamide gel electrophoresis. Portions of the chapter that are not harmonized with the other two pharmacopeias are marked by… Read More <1056> BIOTECHNOLOGY-DERIVED ARTICLES -- POLYACRYLAMIDE GEL ELECTROPHORESIS A paragraph before the Introduction was deleted: This chapter provides guidance and procedures used for characterization of biotechnology-derived articles by polyacrylamide gel electrophoresis. Portions of the chapter that are not harmonized with the other two pharmacopeias are marked by the symbol ♦. This chapter is harmonized with the corresponding chapter in JP and EP. Other characterization tests, also harmonized, are shown in Biotechnology-Derived Articles—Amino Acid Analysis <1052>, Biotechnology-Derived Articles—Capillary Electrophoresis <1053>, Biotechnology-Derived Articles—Isoelectric Focusing <1054>, Biotechnology-Derived Articles—Peptide Mapping <1055>, and Biotechnology-Derived Articles—Total Protein Assay <1057>.
<1047> GENE THERAPY PRODUCTS	REGULATIONS AND STANDARDS	USP38–NF33	883	29-May-2015	1-Jun-2015	USP39–NF34	USP39–NF34	Line 8: Delete and, in particular, www.fda.gov/cber/publications.htm
<1047> GENE THERAPY PRODUCTS	APPENDIX	USP38–NF33	883	29-May-2015	1-Jun-2015	USP39–NF34	USP39–NF34	Line 8 of National and International Regulatory Documents: Delete (http://www4.od.nih.gov/oba/guidelines.html)
<1197> GOOD DISTRIBUTION PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS	SECTION 2: QUALITY, ORGANIZATION, AND DOCUMENTATION/2.8 Contract Activities	USP38–NF33	1396	29-May-2015	1-Jun-2015	USP39–NF34	USP39–NF34	Footnote 2: Change http://whqlibdoc.who.int/trs/WHO_TRS_917_annex2.pdf (Accessed June 30, 2011) to: … Read More <1197> GOOD DISTRIBUTION PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS Footnote 2: Change http://whqlibdoc.who.int/trs/WHO_TRS_917_annex2.pdf (Accessed June 30, 2011) to: http://who.int/medicines/areas/quality_safety/quality_assurance/GoodtradeDistributionPracticesTRS917Annex2.pdf?ua=1 (Accessed March 2, 2015)
<1197> GOOD DISTRIBUTION PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS	SECTION 4: RETURNED GOODS, DISPATCH, TRANSPORT, IMPORTATION, ADULTERATION, AND TRACEABILITY/4.7 Importation	USP38–NF33	1396	29-May-2015	1-Jun-2015	USP39–NF34	USP39–NF34	Footnote 11: Delete http://www.fda.gov/ForIndustry/ImportProgram/AdmissibilityDeterminationsforShipmentsofForeign-originOASIS/ucm077691.htm (Accessed June 6,… Read More <1197> GOOD DISTRIBUTION PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS Footnote 11: Delete http://www.fda.gov/ForIndustry/ImportProgram/AdmissibilityDeterminationsforShipmentsofForeign-originOASIS/ucm077691.htm (Accessed June 6, 2011).
REAGENTS	REAGENT SPECIFICATIONS/Ferric Sulfate	USP38–NF33	1841	29-May-2015	1-Jun-2015	USP39–NF34	USP39–NF34	Line 1: Change [10028-22-5] to: [15244-10-7]
ALUMINUM CHLOROHYDRATE	CHEMICAL INFORMATION	USP38–NF33	2130	29-May-2015	1-Jun-2015	USP39–NF34	USP39–NF34	Line 8: Change Dihydrate [12042-91-0].Anhydrous [1327-41-9]. to: Dihydrate [12359-72-7].Anhydrous [12042-91-0].
AZATHIOPRINE	ASSAY/Procedure	USP38–NF33	2334	29-May-2015	1-Jun-2015	USP39–NF34	USP39–NF34	Line 1 of Standard stock solution: Change 0.1 mg/mL of USP Azathioprine RS prepared as follows. to: 0.5 mg/mL of USP Azathioprine RS prepared as follows.
BENZOYL PEROXIDE GEL	IMPURITIES/Organic Impurities	USP38–NF33	2399	29-May-2015	1-Jun-2015	USP39–NF34	USP39–NF34	Line 18 of Standard solution D: Change hydrous benzoyl peroxide (C₁₄H₁₀O₄). to: anhydrous benzoyl peroxide (C₁₄H₁₀O₄).
CEFAZOLIN FOR INJECTION	ASSAY/Procedure	USP38–NF33	2652	29-May-2015	1-Jun-2015	USP39–NF34	USP39–NF34	Line 7 of Analysis: Change Result = (R_U/R_S) × (C_S/C_U) × P × F × 100 to: Result = (R_U/R_S) × (C_S… Read More CEFAZOLIN FOR INJECTION Line 7 of Analysis: Change Result = (R_U/R_S) × (C_S/C_U) × P × F × 100 to: Result = (R_U/R_S) × (C_S/C_U) × P × 100 AND Line 17 of Analysis: Change P = potency of cefadroxil in USP Cefadroxil RS (µg/mg) to: P = potency of cefazolin in USP Cefazolin RS (mg/mg) AND Line 19 of Analysis: Delete F = conversion factor, 0.001 mg/µg
CEFIXIME	CHEMICAL INFORMATION	USP38–NF33	2665	29-May-2015	1-Jun-2015	USP39–NF34	USP39–NF34	Line 9: Change [79350-37-1]. to: [125110-14-7]. Anhydrous [79350-37-1].