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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
SCAFFOLD BOVINE DERMIS SPECIFIC TESTS USP40–NF35 6113 26-May-2017 1-Jun-2017 USP41–NF36 USP41–NF36 Line 5 of Carbohydrate Content/Acceptance criteria: Change
Moisture Content
to:
Loss on Drying
AND
Line 3 of Suture Retention Force/Analysis: Change
40
to:
4-0
TIMOLOL MALEATE IDENTIFICATION/B. First Supplement to USP40–NF35 8416 26-May-2017 1-Jun-2017 USP41–NF36 USP41–NF36 Line 1: Change
major peak of the Sample solution corresponds to that of the Standard solution,
to:
timolol peak of the Sample solution corresponds to that of the System suitability solution,
<127> FLOW CYTOMETRIC ENUMERATION OF CD34+ CELLS SAMPLE PREPARATION/Table 1. Dot Plot Descriptions and Gating Instructions USP40–NF35 216 26-May-2017 1-Jun-2017 USP41–NF36 USP41–NF36 Column 4 for Step 6: Add
• For counting bead enumeration, proceed to either Step 7 or Step 8 according to the recommendations of the bead manufacturer.
CONSTRUCT HUMAN FIBROBLASTS IN BILAYER SYNTHETIC SCAFFOLD SPECIFIC TESTS/Metabolic Activity Assessment USP40–NF35 3561 26-May-2017 1-Jun-2017 USP41–NF36 USP41–NF36 Line 2 of L-Glutamine solution: Change
29.2 g
to:
2.92 g
PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 2 USP40–NF35 5720 26-May-2017 1-Jun-2017 USP41–NF36 USP41–NF36 Line 3 of Standard solution: Change
USP Metformin Hydrochloride RS in Diluent A
to:
USP Metformin Hydrochloride RS from the Metformin standard stock solution in Diluent A
METHIONINE IMPURITIES/Related Compounds First Supplement to USP40–NF35 8337 26-May-2017 1-Jun-2017 USP41–NF36 USP41–NF36 Row 5 of Column 3 of Table 2: Change
0.1
to:
1.0
<1125> NUCLEIC ACID-BASED TECHNIQUES—GENERAL APPENDICES/Appendix 1: Regulations and Standards USP40–NF35 1471 26-May-2017 1-Jun-2017 USP41–NF36 USP41–NF36 Line 1 of bullet 1: Change
"Review Criteria for Nucleic Acid Amplification-Based In Vitro Diagnostic Devices for Direct Detection of Infectious Microorganisms" (1993)
to:
"Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens" (2005)
MYCOPHENOLATE MOFETIL FOR ORAL SUSPENSION ASSAY/Procedure USP40–NF35 5251 26-May-2017 1-Jun-2017 USP41–NF36 USP41–NF36 Line 3 of Sample solution: Change
45-µm pore size.
to:
0.45-µm pore size.
EVENING PRIMROSE OIL CAPSULES STRENGTH/Analysis USP40–NF35 6952 26-May-2017 1-Jun-2017 USP41–NF36 USP41–NF36 In the first variable definition list: Change
mS = weight of USP Methyl Ester RS in the Standard solution (mg)
to:
mS = weight of the relevant USP Methyl Ester RS in the Standard solution (mg)
TIMOLOL MALEATE IMPURITIES/Enantiomeric Purity First Supplement to USP40–NF35 8416 26-May-2017 1-Jun-2017 USP41–NF36 USP41–NF36 Line 6 of Chromatographic system: Delete
Autosampler temperature: 4°
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
MYCOPHENOLATE MOFETIL ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP39–NF34 4957 31-Mar-2017 1-Apr-2017 USP41–NF36 USP41–NF36 Line 5 of USP Mycophenolate Mofetil Related Compound A RS: Change
C23H31NO7
to:
C22H29NO7
VINORELBINE INJECTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP39–NF34 6371 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.
MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS IMPURITIES/Organic Impurities First Supplement to USP39–NF34 8101 31-Mar-2017 1-Apr-2017 USP41–NF36 USP41–NF36 Change
Buffer, Mobile phase, Diluent, and Sample solution: Prepare as directed in the Assay.
to:
Buffer, Mobile phase, and Diluent: Prepare as directed in the Assay.
AND
Add
Sample solution: Use the Sample… Read More
<1602> SPACERS AND VALVED HOLDING CHAMBERS USED WITH INHALATION AEROSOLS—CHARACTERIZATION TESTS 1. INTRODUCTION/1.5 Definitions of Key Terms Relating to This Chapter USP40–NF35 1988 31-Mar-2017 1-Apr-2017 USP41–NF36 USP41–NF36 Bottom right corner of Figure 1:Change
VHC mouthpiece
to:
Spacer mouthpiece
GRANISETRON HYDROCHLORIDE TABLETS 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.
DOBUTAMINE INJECTION IDENTIFICATION/A. USP39–NF34 3561 31-Mar-2017 1-Apr-2017 USP41–NF36 USP41–NF36 Line 1 of Sample solution: Change
10 mg/mL of dobutamine hydrochloride in methanol, clarified by centrifugation
to:
Use the neat Injection.
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
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