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Errata - English

PDF CSV November 24, 2022 through November 24, 2024 All Errata for USP–NF How to use
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Monograph Title Section Source Publication Page Number Errata Post Date Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
SORBITOL SOLUTION ASSAY/Procedure/Analysis USP39–NF34 5897 31-Mar-2017 1-Apr-2017 USP41–NF36 USP41–NF36 In the variable definition list: Change
CU = nominal concentration of Sorbitol Solution in the Sample solution (mg/g)
to:
CU = concentration of Sorbitol Solution in the Sample solution (mg/g)
MILK THISTLE TABLETS STRENGTH/Content of Silymarin USP39–NF34 6767 31-Mar-2017 1-Apr-2017 USP41–NF36 USP41–NF36 Row 2 of Column 2 of Table 1: Change
0
to:
85
AND
Row 2 of Column 3 of Table 1: Change
0
to:
15
ROPINIROLE EXTENDED-RELEASE TABLETS IMPURITIES/Organic Impurities/Analysis Second Supplement to USP39–NF34 8814 31-Mar-2017 1-Apr-2017 USP41–NF36 USP41–NF36 Line 8 of the variable definition list of the first equation: Change
CU = nominal concentration of ropinirole related compound B free base in the Sample solution (µg/mL)
to:
CU = nominal concentration of ropinirole in the … Read More
DESLORATADINE ORALLY DISINTEGRATING TABLETS IMPURITIES/Organic Impurities First Supplement to USP40–NF35 Online 31-Mar-2017 1-Apr-2017 USP41–NF36 USP41–NF36 Line 5 of Sample solution: Change
Add 70% of the flask volume of Mobile phase
to:
Add 70% of the flask volume of Diluent
MYCOPHENOLATE MOFETIL FOR INJECTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP39–NF34 4960 31-Mar-2017 1-Apr-2017 USP41–NF36 USP41–NF36 Line 5 of Mycophenolate Mofetil Related Compound A RS: Change
C23H31NO7
to:
C22H29NO7
POWDERED MILK THISTLE EXTRACT COMPOSITION/Content of Silymarin USP39–NF34 6764 31-Mar-2017 1-Apr-2017 USP41–NF36 USP41–NF36 Row 2 of Column 2 of Table 1: Change
0
to:
85
AND
Row 2 of Column 3 of Table 1: Change
0
to:
15
REAGENTS, INDICATORS AND SOLUTIONS Solutions/Volumetric Solutions Second Supplement to USP39–NF34 8458 31-Mar-2017 1-Apr-2017 USP41–NF36 USP41–NF36 Line 3 of 0.07 N Ferrous Ammonium Sulfate VS: Change
In a 100-mL volumetric flask,
to:
In a 1000-mL volumetric flask,
PENICILLIN G PROCAINE SPECIFIC TESTS/Content of Penicillin G and Procaine/Analysis USP40–NF35 5607 31-Mar-2017 1-Apr-2017 USP41–NF36 USP41–NF36 Line 7 of the variable definition list for the first equation: Change
CU = concentration of Penicillin G Procaine in the Sample solution (mg)
to:
CU = concentration of Penicillin G Procaine in the Sample solution (mg/mL)
… Read More
ALMOTRIPTAN TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Revision Bulletin (Official February 01, 2017) Online 31-Mar-2017 1-Apr-2017 USP41–NF36 USP41–NF36 Line 4 of USP Almotriptan Related Compound B RS: Change
½C4H4O
to:
½C4H4O4
EZETIMIBE IMPURITIES/Organic Impurities, Procedure 1/System suitability/Suitability requirements USP39–NF34 3840 31-Mar-2017 1-Apr-2017 USP41–NF36 USP41–NF36 Line 2 of Resolution: Change
Standard solution
to:
System suitability solution
VINORELBINE TARTRATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP39–NF34 6370 31-Mar-2017 1-Apr-2017 USP41–NF36 USP41–NF36 Line 2 of USP Vinorelbine Related Compound A RS: Change
4-O-Deacetylvinorelbine.
to:
4-O-Deacetylvinorelbine tartrate.
MAGNESIUM ALUMINOMETASILICATE ASSAY/Magnesium Oxide USP39–NF34 7375 31-Mar-2017 1-Apr-2017 USP41–NF36 USP41–NF36 Line 5 of Analysis: Change
eriochrome black TS trituration
to:
eriochrome black T trituration
<481> RIBOFLAVIN ASSAY ASSAY USP40–NF35 386 31-Mar-2017 1-Apr-2017 USP41–NF36 USP41–NF36 Line 2 of the variable definition list in Chemical Methods, Procedure 1/Analysis: Change
sodium hydrofluorite
to:
sodium hydrosulfite
GRANISETRON HYDROCHLORIDE INJECTION USP Reference standards <11> First Supplement to USP40–NF35 Online 31-Mar-2017 1-Apr-2017 USP41–NF36 USP41–NF36 Line 3 of USP Granisetron Related Compound C RS: Change
carboxamide.
to:
carboxamide hydrochloride.
MYCOPHENOLATE MOFETIL FOR ORAL SUSPENSION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP39–NF34 4961 31-Mar-2017 1-Apr-2017 USP41–NF36 USP41–NF36 Line 5 of Mycophenolate Mofetil Related Compound A RS: Change
C23H31NO7
to:
C22H29NO7
MILK THISTLE CAPSULES STRENGTH/Content of Silymarin USP39–NF34 6765 31-Mar-2017 1-Apr-2017 USP41–NF36 USP41–NF36 Row 2 of Column 2 of Table 1: Change
0
to:
85
AND
Row 2 of Column 3 of Table 1: Change
0
to:
15
MAGNESIUM ALUMINUM SILICATE SPECIFIC TESTS/Viscosity/Acceptance criteria Second Supplement to USP39–NF34 8558 31-Mar-2017 1-Apr-2017 USP41–NF36 USP41–NF36 Line 1 of Type IA: Change
225–600
to:
225–600mPa · s
AND
Line 1 of Type IB: Change
150–450
to:
150–450 mPa · s
AND
Line 1 of Type IC: Change
800–2200
to:
800–2200 mPa · s
AND
Line 1 of Type IIA: Change
100–300
to:
… Read More
RINGER'S INJECTION ASSAY USP40–NF35 6019 31-Mar-2017 1-Apr-2017 USP41–NF36 USP41–NF36 Line 1 of Calcium/Instrumental conditions/Mode: Change
spectrophotometer
to:
spectrophotometry
AND
Line 1 of Potassium/Solution A: Change
Suitable wetting agent
to:
Suitable nonionic wetting agent
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM IMPURITIES/Organic Impurities: Limit of Clotrimazole Related Compound A USP39–NF34 3262 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 In the variable definition list in Analysis: Change
CS = concentration of USP Clotrimazole Related Compound A RS in the Clotrimazole related compound A stock solution (mg/mL)
to:
CS = concentration of USP Clotrimazole… Read More
TERAZOSIN TABLETS IMPURITIES/Organic Impurities/Procedure USP39–NF34 6045 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 1 of Sample solution: Change
Transfer 15 mg of the powder from the crushed Tablets
to:
Transfer a suitable amount of powder, equivalent to 15 mg of terazosin hydrochloride, from the crushed Tablets
TURMERIC COMPOSITION/Content of Curcuminoids/Chromatographic system USP39–NF34 6866 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 1 of Column: Change
4.6-mm × 20-cm;
to:
4.6-mm × 25-cm;
PROMETHAZINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP39–NF34 8784 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 2 of USP Promethazine Related Compound B RS: Change
Isopromethazine;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine.
C17H20N2S 282.42
to:
Isopromethazine hydrochloride;
N,N-Dimethyl-2-(10H-… Read More
TACROLIMUS CAPSULES PERFORMANCE TESTS/Dissolution <711>/Test 5 Second Supplement to USP39–NF34 8834 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 1 of Medium: Change
0.5 g/L
to:
0.05 g/L
ADENINE CHEMICAL INFORMATION USP39–NF34 2346 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 2: Change
1H-Purin-6-amine;
to:
9H-Purin-6-amine;
AMINOPHYLLINE ORAL SOLUTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP40–NF35 2739 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 2 of USP Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C6H10N4O 154.17
to:
Theophyllidine;
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride… Read More
BRINZOLAMIDE OPHTHALMIC SUSPENSION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP39–NF34 2789 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 2 of USP Brinzolamide Related Compound B RS: Change
(R-4-Amino)-2,3-dihydro-2-(3-methoxypropyl)-4H-thieno[3,2,-e]-thiazine-6-sulfonamide-1,1-dioxide ethandioate 1:1.
to:
(R)-4-Amino-2-(3-methoxypropyl)-3,4-dihydro-2H-thieno[3,2-e][1,2]thiazine-6-… Read More
HALCINONIDE IMPURITIES/Organic Impurities/Chromatographic system USP39–NF34 4175 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 1 of Column: Change
1.8-µm packing L1
to:
1.7-µm packing L1
CURCUMINOIDS CAPSULES STRENGTH/Content of Curcuminoids/Chromatographic system USP39–NF34 6583 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 1 of Column: Change
4.6-mm × 20-cm;
to:
4.6-mm × 25-cm;
ADAPALENE GEL ASSAY/Procedure First Supplement to USP39–NF34 7983 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 5 of Sample stock solution: Change
Cool to room temperature and dilute with Diluent to volume.
to:
Cool to room temperature and dilute with Mobile phase to volume.
PROMETHAZINE HYDROCHLORIDE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP39–NF34 8788 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 2 of USP Promethazine Related Compound B RS: Change
Isopromethazine;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine.
C17H20N2S 284.42
to:
Isopromethazine hydrochloride;
N,N-Dimethyl-2-(10H-… Read More
AMINOPHYLLINE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP40–NF35 2735 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 2 of USP Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C6H10N4O 154.17
to:
Theophyllidine;
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride… Read More
ATROPINE SULFATE ASSAY/Procedure USP39–NF34 2638 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 4 of Analysis: Change
(C17H23NO32 · H2SO4)
to:
[(C17H23NO3)2 · H2SO4]
LEVETIRACETAM EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 7 Revision Bulletin (Official October 01, 2016) Online 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 2 of Standard solution: Change
Buffer A.
to:
Medium.
EFAVIRENZ IMPURITIES/Organic Impurities USP39–NF34 3656 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Row 4 of Column 1 of Procedure 1/Impurity Table 1:Change
Efavirenz pent-3-ene-1-yne (cis)c
to:
Efavirenz pent-3-ene-1-yne (trans)c
AND
Row 5 of Column 1 of Procedure 1/Impurity Table 1:Change
Efavirenz pent-3-ene-1-… Read More
TETRACYCLINE HYDROCHLORIDE IMPURITIES/Organic Impurities USP39–NF34 6080 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 16 of Analysis: Delete
Calculate the percentage of any unspecified impurity in the portion of Tetracycline Hydrochloride taken:
Result = (rU/rS) × (CS/CU) × 100
rU… Read More
POWDERED TURMERIC COMPOSITION/Content of Curcuminoids/Chromatographic system USP39–NF34 6867 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 1 of Column: Change
4.6-mm × 20-cm;
to:
4.6-mm × 25-cm;
PROMETHAZINE HYDROCHLORIDE INJECTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP39–NF34 8785 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 2 of USP Promethazine Related Compound B RS: Change
Isopromethazine;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine.
C17H20N2S 284.42
to:
Isopromethazine hydrochloride;
N,N-Dimethyl-2-(10H-… Read More
THEOPHYLLINE ADDITIONAL REQUIREMENTS/USP Reference Standards RS <11> Second Supplement to USP39–NF34 8844 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 3 of USP Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C6H10N4O 154.17
to:
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride monohydrate.
C6… Read More
AMINOPHYLLINE TABLETS PERFORMANCE TESTS/Uniformity of Dosage Units <905>/Procedure for content uniformity USP39–NF34 2483 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Variable definition for CU in Analysis: Change
(mg/mL)
to:
to:(µg/mL)
AMINOPHYLLINE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP40–NF35 2742 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 2 of USP Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C6H10N4O 154.17
to:
Theophyllidine;
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride… Read More
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM ASSAY/Procedure USP39–NF34 3262 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 In the first variable definition list in Analysis: Change
CS = concentration of USP Clotrimazole RS in the Clotrimazole stock solution (mg/mL)
to:
CS = concentration of USP Clotrimazole RS in the Standard solution (mg/… Read More
TERAZOSIN TABLETS ASSAY/Procedure USP39–NF34 6045 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 3 of System suitability solution: Change
Standard solution
to:
Standard stock solution
CURCUMINOIDS TABLETS STRENGTH/Content of Curcuminoids/Chromatographic system USP39–NF34 6585 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 1 of Column: Change
4.6-mm × 20-cm;
to:
4.6-mm × 25-cm;
IMIPRAMINE PAMOATE CAPSULES PERFORMANCE TESTS/Dissolution <711>/Test 1 Second Supplement to USP39–NF34 8681 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 6 of Analysis: Change
Resulti = (ri/rs) × Cs × [M × (Mr1/Mr2)] × V x (1/L) × 100
to:
Resulti… Read More
SODIUM CHLORIDE IMPURITIES/Limit of Potassium/Instrumental conditions Second Supplement to USP39–NF34 8821 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 1 of Mode: Change
Atomic absorption spectrophotometry
to:
Atomic emission spectroscopy
AMINOPHYLLINE INJECTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP40–NF35 2737 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 2 of USP Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C6H10N4O 154.17
to:
Theophyllidine;
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride… Read More
BRINZOLAMIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP39–NF34 2788 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 2 of USP Brinzolamide Related Compound B RS: Change
(R-4-Amino)-2,3-dihydro-2-(3-methoxypropyl)-4H-thieno[3,2,-e]-thiazine-6-sulfonamide-1,1-dioxide ethandioate 1:1.
to:
(R)-4-Amino-2-(3-methoxypropyl)-3,4-dihydro-2H-thieno[3,2-e][1,2]thiazine-6-… Read More
<1058> ANALYTICAL INSTRUMENT QUALIFICATION ANALYTICAL INSTRUMENT QUALIFICATION PROCESS/Qualification Phases First Supplement to USP40–NF35 8083 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 2 of paragraph 1 of Operational Qualification: Change
OQ demonstrates fitness for the selected use, and should reflect the contents of the DQ document.
to:
OQ demonstrates fitness for the selected use, and should reflect URS.
AND
Line 2 of paragraph 3 of Operational… Read More
ENTECAVIR ASSAY/Procedure USP39–NF34 3704 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 5 of Analysis: Change
Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
to:
Result = (rU/rS… Read More
CURCUMINOIDS COMPOSITION/Content of Curcuminoids/Chromatographic system USP39–NF34 6582 27-Jan-2017 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 1 of Column: Change
4.6-mm × 20-cm;
to:
4.6-mm × 25-cm;