How to Use the USP–NF Errata Table

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Monograph Title Section Source Publication Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description

<1125> NUCLEIC ACID-BASED TECHNIQUES—GENERAL

APPENDICES/Appendix 1: Regulations and Standards

USP40–NF35

1471 01-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)


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)

<127> FLOW CYTOMETRIC ENUMERATION OF CD34+ CELLS

SAMPLE PREPARATION/Table 1. Dot Plot Descriptions and Gating Instructions

USP40–NF35

216 01-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.

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.

<212> OLIGOSACCHARIDE ANALYSIS

SEPARATION AND IDENTIFICATION OF OLIGOSACCHARIDES

USP40–NF35

273 01-Jun-2017

USP41–NF36

USP41–NF36

Line 1 of Normal Phase Chromatography/HILIC/Ammonium formate buffer: Change
Add 1.4 M ammonia solution to 1.4 M formic acid solution.
to:
Add 1.4 M ammonia solution to 1.4 M formic acid solution until a pH of 4.4 is obtained.


Line 1 of Normal Phase Chromatography/HILIC/Ammonium formate buffer: Change
Add 1.4 M ammonia solution to 1.4 M formic acid solution.
to:
Add 1.4 M ammonia solution to 1.4 M formic acid solution until a pH of 4.4 is obtained.

<603> TOPICAL AEROSOLS

DELIVERED-DOSE UNIFORMITY

USP40–NF35

499 01-Jun-2017

USP41–NF36

USP41–NF36

Line 2: Change
proceed as directed in the test for Delivered Dose Uniformity in Metered-Dose Inhalers and Dry Powder Inhalers, as described in <601>,
to:
proceed as directed in Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests <601>, A. Delivered-Dose Uniformity/A.2 Inhalation Aerosols and Inhalation Sprays and A.4 Inhalation Powders,
AND
Line 4: Delete
Unless otherwise stated in the individual monograph, apply the acceptance criteria for Metered-Dose Inhalers and Dry Powder Inhalers as described in <601>.





Line 2: Change
proceed as directed in the test for Delivered Dose Uniformity in Metered-Dose Inhalers and Dry Powder Inhalers, as described in <601>,
to:
proceed as directed in Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests <601>, A.

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ACETYLCYSTEINE SOLUTION

ASSAY/Procedure

USP40–NF35

2586 01-Jun-2017

USP41–NF36

USP41–NF36

Line 3 of Sample solution: Change
Standard stock solution
to:
Sample stock solution


Line 3 of Sample solution: Change
Standard stock solution
to:
Sample stock solution

CONSTRUCT HUMAN FIBROBLASTS IN BILAYER SYNTHETIC SCAFFOLD

SPECIFIC TESTS/Metabolic Activity Assessment

USP40–NF35

3561 01-Jun-2017

USP41–NF36

USP41–NF36

Line 2 of L-Glutamine solution: Change
29.2 g
to:
2.92 g


Line 2 of L-Glutamine solution: Change
29.2 g
to:
2.92 g

DOCETAXEL

IMPURITIES/Organic Impurities, Procedure 1

Revision Bulletin (Official August 01, 2016)

ONLINE 01-Jun-2017

USP41–NF36

USP41–NF36

Footnote c of Table 2: Change
(2aR,4R,4aS,9S,11S,12S,12aR,12bS)-1,2a,3,4,4a,6,9,10,11,12,12a,12b-Dodecahydro-4, 9,11,12,12b-pentahydroxy-4a,8,13,13-tetramethyl-7,11-methano-5H-cyclodeca[3,4]benz[1,2-b]oxet-5,6-dione 12b-acetate, 12-benzoate, 9-ester with (2R,3S)-N-formyl-3-phenylisoserine.
to:
(2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)‐12b‐Acetoxy‐9‐(((2R,3S)‐3‐formamido‐2‐hydroxy‐3‐phenylpropanoyl)oxy)‐4,6,11‐trihydroxy‐4a,8,13,13‐tetramethyl‐5‐oxo‐2a,3,4,4a,5,6,9,10,11,12,12a,12b‐dodecahydro‐1H‐7,11‐methanocyclodeca[3,4]benzo[1,2‐b]oxet-12‐yl benzoate.
AND
Footnote d of Table 2: Change
(2aR,4R,4aS,6R,9S,11S,12S,12aR,12bS)-6-{[(2,2-Dichloroethoxy)carbonyl]oxy}-1,2a,3,4,4a,6,9,10,11,12,12a,12b-dodecahydro-4,9,11,12,12b-pentahydroxy-4a,8,13,13-tetramethyl-7,11-methano-5H-cyclodeca[3,4]benz[1,2-b)oxet-5-one 12b-acetate, 12-benzoate, 9-ester with (2R,3S)-N-tert-butoxycarbonyl-e-phenylisoserine.
to:
(2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)‐6‐{[(2,2‐Dichloroethoxy)carbonyl]oxy}‐1,2a,3,4,4a,6,9,10,11,12,12a,12b‐dodecahydro‐4,9,11,12,12b‐pentahydroxy‐4a,8,13,13‐tetramethyl‐7,11‐methano‐5H‐cyclodeca[3,4]benz[1,2‐b]oxet‐5‐one 12b‐acetate, 12‐benzoate, 9‐ester with (2R,3S)‐N‐tert-butoxycarbonyl‐3‐phenylisoserine.







Footnote c of Table 2: Change
(2aR,4R,4aS,9S,11S,12S,12aR,12bS)-1,2a,3,4,4a,6,9,10,11,12,12a,12b-Dodecahydro-4, 9,11,12,12b-pentahydroxy-4a,8,13,13-tetramethyl-7,11-methano-5H-cyclodeca[3,4]benz[1,2-b]oxet-5,6-dione 12b-acetate, 12-benzoate, 9-ester with (2R,3S)-N-formyl-3-phenylisoserine.
to:
(2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)‐12b‐Acetoxy‐9‐(((2R,3S)‐3‐formamido‐2‐hydroxy‐3‐phenylpropanoyl)oxy)‐4,6,11‐trihy

Read more

EVENING PRIMROSE OIL CAPSULES

STRENGTH/Analysis

USP40–NF35

6952 01-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)


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)

GLUCONOLACTONE

ASSAY/Procedure

USP40–NF35

4412 01-Jun-2017

USP41–NF36

USP41–NF36

Line 5 of Analysis: Change
Each mL of Back-titrant
to:
Each milliliter of Titrant


Line 5 of Analysis: Change
Each mL of Back-titrant
to:
Each milliliter of Titrant

IOHEXOL

IMPURITIES/Limit of Free Iodide/Analysis

USP40–NF35

4649 01-Jun-2017

USP41–NF36

USP41–NF36

Line 3 of variable definition list: Change
0.1269 mg/mEq
to:
126.9 mg/mEq


Line 3 of variable definition list: Change
0.1269 mg/mEq
to:
126.9 mg/mEq

METHIONINE

IMPURITIES/Related Compounds

First Supplement to USP40–NF35

8337 01-Jun-2017

USP41–NF36

USP41–NF36

Row 5 of Column 3 of Table 2: Change
0.1
to:
1.0


Row 5 of Column 3 of Table 2: Change
0.1
to:
1.0

METHYLDOPA

ASSAY/Procedure/Chromatographic system

First Supplement to USP40–NF35

8339 01-Jun-2017

USP41–NF36

USP41–NF36

Line 1 of Injection volume: Change
1 mL
to:
20 µL


Line 1 of Injection volume: Change
1 mL
to:
20 µL

MYCOPHENOLATE MOFETIL FOR ORAL SUSPENSION

ASSAY/Procedure

USP40–NF35

5251 01-Jun-2017

USP41–NF36

USP41–NF36

Line 3 of Sample solution: Change
45-µm pore size.
to:
0.45-µm pore size.


Line 3 of Sample solution: Change
45-µm pore size.
to:
0.45-µm pore size.

PHENYTOIN ORAL SUSPENSION

IMPURITIES/Organic Impurities

USP40–NF35

5690 01-Jun-2017

USP41–NF36

USP41–NF36

Line 1 of Sample solution: Change
1 mg/mL of Oral Suspension in Diluent
to:
Nominally 1 mg/mL of phenytoin prepared as follows. Weigh and transfer a suitable volume of Oral Suspension to an appropriate volumetric flask. Add methanol to about 20% of the final flask volume and dissolve. Dilute with Diluent to volume. Dissolve with the aid of sonication, if necessary.


Line 1 of Sample solution: Change
1 mg/mL of Oral Suspension in Diluent
to:
Nominally 1 mg/mL of phenytoin prepared as follows. Weigh and transfer a suitable volume of Oral Suspension to an appropriate volumetric flask. Add methanol to about 20% of the final flask volume and dissolve. Dilute with Diluent to volume. Dissolve with the aid of sonication, if necessary.

PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS

PERFORMANCE TESTS/Dissolution <711>/Test 2

USP40–NF35

5720 01-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


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

POLYETHYLENE GLYCOL 3350

SPECIFIC TESTS/Apparent Weight-Average Molecular Weight and Polydispersity

USP40–NF35

5745 01-Jun-2017

USP41–NF36

USP41–NF36

Line 1 of Standard solution: Change
Standard solution: 1.0 mg/mL each of five polyethylene glycol standards with molecular weights of 1000,2000, 3000, 4000, and 6000 g/mol (Da) in Mobilephase. Pass a portion of the solution
to:
Standard solutions: Prepare 1.0 mg/mL each of five polyethylene glycol standards with molecular weights of 1000,2000, 3000, 4000, and 6000 g/mol (Da) in Mobilephase separately in five individual flasks. Pass a portion of each solution
AND
Line 1 of Analysis/Samples: Change
Standard solution and Sample solution
to:
Standard solutions and Sample solution
AND
Line 3 of Analysis: Change
Separately inject equal volumes of the Standard solution
to:
Separately inject equal volumes of the Standard solutions












Line 1 of Standard solution: Change
Standard solution: 1.0 mg/mL each of five polyethylene glycol standards with molecular weights of 1000,2000, 3000, 4000, and 6000 g/mol (Da) in Mobilephase. Pass a portion of the solution
to:
Standard solutions: Prepare 1.0 mg/mL each of five polyethylene glycol standards with molecular weights of 1000,2000, 3000, 4000, and 6000 g/mol (Da) in Mobilephase separately in five individual flasks.

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SCAFFOLD BOVINE DERMIS

SPECIFIC TESTS

USP40–NF35

6113 01-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







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

SUCROSE

SPECIFIC TESTS/Color Value/Analysis

USP40–NF35

7938 01-Jun-2017

USP41–NF36

USP41–NF36

Line 6 of the variable definition list: Change
The absolute difference between two results is NMT 3.
to:
Suitability requirements
Repeatability: The absolute difference between two results is NMT 3.



Line 6 of the variable definition list: Change
The absolute difference between two results is NMT 3.
to:
Suitability requirements
Repeatability: The absolute difference between two results is NMT 3.

TIMOLOL MALEATE

IDENTIFICATION/B.

First Supplement to USP40–NF35

8416 01-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,


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,

TIMOLOL MALEATE

IMPURITIES/Enantiomeric Purity

First Supplement to USP40–NF35

8416 01-Jun-2017

USP41–NF36

USP41–NF36

Line 6 of Chromatographic system: Delete
Autosampler temperature: 4°

Line 6 of Chromatographic system: Delete
Autosampler temperature: 4°

<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 01-Apr-2017

USP41–NF36

USP41–NF36

Bottom right corner of Figure 1:Change
VHC mouthpiece
to:
Spacer mouthpiece


Bottom right corner of Figure 1:Change
VHC mouthpiece
to:
Spacer mouthpiece

<481> RIBOFLAVIN ASSAY

ASSAY

USP40–NF35

386 01-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


Line 2 of the variable definition list in Chemical Methods, Procedure 1/Analysis: Change
sodium hydrofluorite
to:
sodium hydrosulfite

ALMOTRIPTAN TABLETS

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

Revision Bulletin (Official February 01, 2017)

ONLINE 01-Apr-2017

USP41–NF36

USP41–NF36

Line 4 of USP Almotriptan Related Compound B RS: Change
½C4H4O
to:
½C4H4O4


Line 4 of USP Almotriptan Related Compound B RS: Change
½C4H4O
to:
½C4H4O4

DESLORATADINE ORALLY DISINTEGRATING TABLETS

IMPURITIES/Organic Impurities

First Supplement to USP40–NF35

ONLINE 01-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


Line 5 of Sample solution: Change
Add 70% of the flask volume of Mobile phase
to:
Add 70% of the flask volume of Diluent

DOBUTAMINE INJECTION

IDENTIFICATION/A.

USP39–NF34

3561 01-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.


Line 1 of Sample solution: Change
10 mg/mL of dobutamine hydrochloride in methanol, clarified by centrifugation
to:
Use the neat Injection.

EZETIMIBE

IMPURITIES/Organic Impurities, Procedure 1/System suitability/Suitability requirements

USP39–NF34

3840 01-Apr-2017

USP41–NF36

USP41–NF36

Line 2 of Resolution: Change
Standard solution
to:
System suitability solution


Line 2 of Resolution: Change
Standard solution
to:
System suitability solution

GRANISETRON HYDROCHLORIDE INJECTION

USP Reference standards <11>

First Supplement to USP40–NF35

ONLINE 01-Apr-2017

USP41–NF36

USP41–NF36

Line 3 of USP Granisetron Related Compound C RS: Change
carboxamide.
to:
carboxamide hydrochloride.


Line 3 of USP Granisetron Related Compound C RS: Change
carboxamide.
to:
carboxamide hydrochloride.

GRANISETRON HYDROCHLORIDE TABLETS

USP Reference standards <11>

First Supplement to USP40–NF35

ONLINE 01-Apr-2017

USP41–NF36

USP41–NF36

Line 3 of USP Granisetron Related Compound C RS: Change
carboxamide.
to:
carboxamide hydrochloride.


Line 3 of USP Granisetron Related Compound C RS: Change
carboxamide.
to:
carboxamide hydrochloride.

MAGNESIUM ALUMINOMETASILICATE

ASSAY/Magnesium Oxide

USP39–NF34

7375 01-Apr-2017

USP41–NF36

USP41–NF36

Line 5 of Analysis: Change
eriochrome black TS trituration
to:
eriochrome black T trituration


Line 5 of Analysis: Change
eriochrome black TS trituration
to:
eriochrome black T trituration

MAGNESIUM ALUMINUM SILICATE

SPECIFIC TESTS/Viscosity/Acceptance criteria

Second Supplement to USP39–NF34

8558 01-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:
100–300 mPa · s

















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:
100–300 mPa · s

MILK THISTLE CAPSULES

STRENGTH/Content of Silymarin

USP39–NF34

6765 01-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







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

MILK THISTLE TABLETS

STRENGTH/Content of Silymarin

USP39–NF34

6767 01-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







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

MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS

IMPURITIES/Organic Impurities

First Supplement to USP39–NF34

8101 01-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 stock solution as directed in the Assay.





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 stock solution as directed in the Assay.

MYCOPHENOLATE MOFETIL

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP39–NF34

4957 01-Apr-2017

USP41–NF36

USP41–NF36

Line 5 of USP Mycophenolate Mofetil Related Compound A RS: Change
C23H31NO7
to:
C22H29NO7


Line 5 of USP Mycophenolate Mofetil Related Compound A RS: Change
C23H31NO7
to:
C22H29NO7

MYCOPHENOLATE MOFETIL FOR INJECTION

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP39–NF34

4960 01-Apr-2017

USP41–NF36

USP41–NF36

Line 5 of Mycophenolate Mofetil Related Compound A RS: Change
C23H31NO7
to:
C22H29NO7


Line 5 of Mycophenolate Mofetil Related Compound A RS: Change
C23H31NO7
to:
C22H29NO7

MYCOPHENOLATE MOFETIL FOR ORAL SUSPENSION

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP39–NF34

4961 01-Apr-2017

USP41–NF36

USP41–NF36

Line 5 of Mycophenolate Mofetil Related Compound A RS: Change
C23H31NO7
to:
C22H29NO7


Line 5 of Mycophenolate Mofetil Related Compound A RS: Change
C23H31NO7
to:
C22H29NO7

PENICILLIN G PROCAINE

SPECIFIC TESTS/Content of Penicillin G and Procaine/Analysis

USP40–NF35

5607 01-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)
AND
Line 7 of the variable definition list for the second 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)









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)
AND
Line 7 of the variable definition list for the second equation: Change
CU = concentration of Penicillin G Procaine in the Sample solution (mg)
to:
CU = concentration of Penicillin G Procaine in the Sample solution (

Read more

POWDERED MILK THISTLE EXTRACT

COMPOSITION/Content of Silymarin

USP39–NF34

6764 01-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







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 01-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,


Line 3 of 0.07 N Ferrous Ammonium Sulfate VS: Change
In a 100-mL volumetric flask,
to:
In a 1000-mL volumetric flask,

RINGER'S INJECTION

ASSAY

USP40–NF35

6019 01-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







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

ROPINIROLE EXTENDED-RELEASE TABLETS

IMPURITIES/Organic Impurities/Analysis

Second Supplement to USP39–NF34

8814 01-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 Sample solution (µg/mL)


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 Sample solution (µg/mL)

SORBITOL SOLUTION

ASSAY/Procedure/Analysis

USP39–NF34

5897 01-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)


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)

VINORELBINE INJECTION

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP39–NF34

6371 01-Apr-2017

USP41–NF36

USP41–NF36

Line 2 of USP Vinorelbine Related Compound A RS: Change
4-O-Deacetylvinorelbine.
to:
4-O-Deacetylvinorelbine tartrate.


Line 2 of USP Vinorelbine Related Compound A RS: Change
4-O-Deacetylvinorelbine.
to:
4-O-Deacetylvinorelbine tartrate.

VINORELBINE TARTRATE

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP39–NF34

6370 01-Apr-2017

USP41–NF36

USP41–NF36

Line 2 of USP Vinorelbine Related Compound A RS: Change
4-O-Deacetylvinorelbine.
to:
4-O-Deacetylvinorelbine tartrate.


Line 2 of USP Vinorelbine Related Compound A RS: Change
4-O-Deacetylvinorelbine.
to:
4-O-Deacetylvinorelbine tartrate.

<1058> ANALYTICAL INSTRUMENT QUALIFICATION

ANALYTICAL INSTRUMENT QUALIFICATION PROCESS/Qualification Phases

First Supplement to USP40–NF35

8083 01-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 Qualification/Instrument Function Tests: Change
Holistic tests, which involve the entire system, demonstrate that the whole system complies with user specifications in the DQ.
to:
Holistic tests, which involve the entire system, demonstrate that the whole system complies with URS.







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 Qualification/Instrument Function Tests: Change
Holistic tests, which involve the entire system, demonstrate that the whole system complies with user specifications in the DQ.

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ADAPALENE GEL

ASSAY/Procedure

First Supplement to USP39–NF34

7983 01-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.


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.

ADENINE

CHEMICAL INFORMATION

USP39–NF34

2346 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 2: Change
1H-Purin-6-amine;
to:
9H-Purin-6-amine;


Line 2: Change
1H-Purin-6-amine;
to:
9H-Purin-6-amine;

AMINOPHYLLINE

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP40–NF35

2735 01-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 monohydrate.
C6H10N4O · HCl · H2O 208.65





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 monohydrate.
C6H10N4O · HCl · H2O 208.65

AMINOPHYLLINE INJECTION

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP40–NF35

2737 01-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 monohydrate.
C6H10N4O · HCl · H2O 208.65





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 monohydrate.
C6H10N4O · HCl · H2O 208.65

AMINOPHYLLINE ORAL SOLUTION

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP40–NF35

2739 01-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 monohydrate.
C6H10N4O · HCl · H2O 208.65





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 monohydrate.
C6H10N4O · HCl · H2O 208.65

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