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

<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.

Read more

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

AMINOPHYLLINE TABLETS

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP40–NF35

2742 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 TABLETS

PERFORMANCE TESTS/Uniformity of Dosage Units <905>/Procedure for content uniformity

USP39–NF34

2483 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Variable definition for CU in Analysis: Change
(mg/mL)
to:
to:(µg/mL)


Variable definition for CU in Analysis: Change
(mg/mL)
to:
to:(µg/mL)

ATROPINE SULFATE

DEFINITION

USP39–NF34

2638 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 2: Change
(C17H23NO32 · H2SO4),
to:
[(C17H23NO3)2 · H2SO4],


Line 2: Change
(C17H23NO32 · H2SO4),
to:
[(C17H23NO3)2 · H2SO4],

ATROPINE SULFATE

ASSAY/Procedure

USP39–NF34

2638 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 4 of Analysis: Change
(C17H23NO32 · H2SO4)
to:
[(C17H23NO3)2 · H2SO4]


Line 4 of Analysis: Change
(C17H23NO32 · H2SO4)
to:
[(C17H23NO3)2 · H2SO4]

BRINZOLAMIDE

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP39–NF34

2788 01-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-sulfonamide 1,1-dioxide oxalate.


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-sulfonamide 1,1-dioxide oxalate.

BRINZOLAMIDE OPHTHALMIC SUSPENSION

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP39–NF34

2789 01-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-sulfonamide 1,1-dioxide oxalate.


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-sulfonamide 1,1-dioxide oxalate.

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM

ASSAY/Procedure

USP39–NF34

3262 01-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/mL)
AND
In the second variable definition list in Analysis: Change
CS = concentration of USP Betamethasone Dipropionate RS in the Betamethasone dipropionate stock solution (mg/mL)
to:
CS = concentration of USP Betamethasone Dipropionate RS in the Standard solution (mg/mL)









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/mL)
AND
In the second variable definition list in Analysis: Change
CS = concentration of USP Betamethasone Dipropionate RS in the Betamethasone dipropionate stock solution (mg/mL)
to:
CS = concentration of USP Bet

Read more

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM

IMPURITIES/Organic Impurities: Limit of Clotrimazole Related Compound A

USP39–NF34

3262 01-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 Related Compound A RS in the Standard solution (mg/mL)


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 Related Compound A RS in the Standard solution (mg/mL)

CURCUMINOIDS

COMPOSITION/Content of Curcuminoids/Chromatographic system

USP39–NF34

6582 01-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;


Line 1 of Column: Change
4.6-mm × 20-cm;
to:
4.6-mm × 25-cm;

CURCUMINOIDS CAPSULES

STRENGTH/Content of Curcuminoids/Chromatographic system

USP39–NF34

6583 01-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;


Line 1 of Column: Change
4.6-mm × 20-cm;
to:
4.6-mm × 25-cm;

CURCUMINOIDS TABLETS

STRENGTH/Content of Curcuminoids/Chromatographic system

USP39–NF34

6585 01-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;


Line 1 of Column: Change
4.6-mm × 20-cm;
to:
4.6-mm × 25-cm;

EFAVIRENZ

IMPURITIES/Organic Impurities

USP39–NF34

3656 01-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-yne (trans)d
to:
Efavirenz pent-3-ene-1-yne (cis)d
AND
Row 3 of Column 1 of Procedure 2/Impurity Table 2: Change
Efavirenz pent-3-ene-1-yne (cis)a
to:
Efavirenz pent-3-ene-1-yne (trans)a
AND
Row 4 of Column 1 of Procedure 2/Impurity Table 2:Change
Efavirenz pent-3-ene-1-yne (trans)b
to:
Efavirenz pent-3-ene-1-yne (cis)b

















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-yne (trans)d
to:
Efavirenz pent-3-ene-1-yne (cis)d
AND
Row 3 of Column 1 of Procedure 2/Impurity Table 2: Change
Efavirenz pent-3-ene-1-yne (cis)a
to:
Efavirenz pent-3-ene-1-yne (trans)a<

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ENTECAVIR

ASSAY/Procedure

USP39–NF34

3704 01-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) × (CS/CU) × 100
AND
Line 14 of Analysis: Delete
Mr1=molecular weight of anhydrous entecavir, 277.28
Mr2=molecular weight of entecavir, 295.29






Line 5 of Analysis: Change
Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
to:
Result = (rU/rS) × (CS/CU) × 100
AND
Line 14 of Analysis: Delete
Mr1=molecular weight of anhydrous entecavir, 277.28
Mr2=molecular weight of entecavir, 295.29

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GALANTAMINE EXTENDED-RELEASE CAPSULES

PERFORMANCE TESTS/Dissolution <711>/Test 3

USP40–NF35

4367 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 1of Buffer: Change
To each L of 6.8-g/L potassium phosphate
to:
To each L of 6.8 g/L of monobasic potassium phosphate


Line 1of Buffer: Change
To each L of 6.8-g/L potassium phosphate
to:
To each L of 6.8 g/L of monobasic potassium phosphate

HALCINONIDE

IMPURITIES/Organic Impurities/Chromatographic system

USP39–NF34

4175 01-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


Line 1 of Column: Change
1.8-µm packing L1
to:
1.7-µm packing L1

IMIPRAMINE PAMOATE CAPSULES

PERFORMANCE TESTS/Dissolution <711>/Test 1

Second Supplement to USP39–NF34

8681 01-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 = (ri/rs) × Cs × [M × (Mr1/Mr2)] × D × V × (1/L) × 100
AND
To the variable definition list in Analysis: Add
D = dilution factor of the Sample solution





Line 6 of Analysis: Change
Resulti = (ri/rs) × Cs × [M × (Mr1/Mr2)] × V x (1/L) × 100
to:
Resulti = (ri/rs) × Cs × [M × (Mr1/Mr2)] × D × V × (1/L) × 100
AND
To the variable definition list in Analysis: Add
D = dilution

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LEVETIRACETAM EXTENDED-RELEASE TABLETS

PERFORMANCE TESTS/Dissolution <711>/Test 7

Revision Bulletin (Official October 01, 2016)

ONLINE 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 2 of Standard solution: Change
Buffer A.
to:
Medium.


Line 2 of Standard solution: Change
Buffer A.
to:
Medium.

POWDERED TURMERIC

COMPOSITION/Content of Curcuminoids/Chromatographic system

USP39–NF34

6867 01-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;


Line 1 of Column: Change
4.6-mm × 20-cm;
to:
4.6-mm × 25-cm;

POWDERED TURMERIC EXTRACT

COMPOSITION/Content of Curcuminoids/Chromatographic system

USP39–NF34

6868 01-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;


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 01-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-phenothiazin-10-yl)propan-1-amine hydrochloride.
C17H20N2S · HCl 320.88






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-phenothiazin-10-yl)propan-1-amine hydrochloride.
C17H20N2S · HCl 320.88

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