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

<1207> STERILE PRODUCT PACKAGING−INTEGRITY EVALUATION

5. PRODUCT–PACKAGE QUALITY REQUIREMENTS AND THE MAXIMUM ALLOWABLE LEAKAGE LIMIT/5.1 Sterility and Product Formulation Content must be Preserved; Gas Headspace Content Preservation is not Required

First Supplement to USP39–NF34

7764 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 3 of paragraph 5: Change
ultra-cold storage (<80°)
to:
ultra-cold storage (≤−80°)


Line 3 of paragraph 5: Change
ultra-cold storage (<80°)
to:
ultra-cold storage (≤−80°)

<661.1> PLASTIC MATERIALS OF CONSTRUCTION

TEST METHODS

USP40–NF35

542 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 1 of Physicochemical Tests/Acidity or Alkalinity/BRP indicator solution: Change
1.0 mg/mL of bromophenol blue,
to:
1.0 mg/mL of bromothymol blue,
AND
Line 3 of Plastic Additives/Polyethylene, Cyclic Olefins, and Polypropylene/Phenolic Antioxidants/Test B: Change
tris(2,4-di-tert-butylphenyl) phosphate;
to:
tris(2,4-di-tert-butylphenyl) phosphite;
AND
Line 1 of Plastic Additives/Polyethylene, Cyclic Olefins, and Polypropylene/Phenolic Antioxidants/Test C/Mobile phase: Change
(55:45:5, v/v/v)
to:
(50:45:5, v/v/v)
AND
Line 1 of Plastic Additives/Polyethylene, Cyclic Olefins, and Polypropylene/Nonphenolic Antioxidants/Chromatographic system/Application: Change
20 µL of Sample solution S10, reference solution (o) and the reference solutions corresponding to
to:
20 µL of Sample solution S10 and the reference solutions corresponding to
AND
Line 2 of Plastic Additives/Plasticized Polyvinyl Chloride/USP Reference Standards <11>/USP Plastic Additive 05 RS: Change
Tris(2,4-di-tert-butylphenyl) phosphate.
to:
Tris(2,4-di-tert-butylphenyl) phosphite.  






















Line 1 of Physicochemical Tests/Acidity or Alkalinity/BRP indicator solution: Change
1.0 mg/mL of bromophenol blue,
to:
1.0 mg/mL of bromothymol blue,
AND
Line 3 of Plastic Additives/Polyethylene, Cyclic Olefins, and Polypropylene/Phenolic Antioxidants/Test B: Change
tris(2,4-di-tert-butylphenyl) phosphate;
to:
tris(2,4-di-tert-butylphenyl) phosphite;
AND
Line 1 of Plastic Additives/Polyethylene, Cyclic Olefins, and Polypropylene/Phenolic Antioxidants/Test C/Mob

Read more

<661.2> PLASTIC PACKAGING SYSTEMS FOR PHARMACEUTICAL USE

TEST METHODS/Physicochemical Tests/Water Extraction/Acidity or alkalinity

USP39–NF34

506 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 2 of Methyl red TS 2: Change
NMT 0.1 mL of 0.02 N hydrochloric acid
to:
NMT 0.1 mL of 0.02 N sodium hydroxide


Line 2 of Methyl red TS 2: Change
NMT 0.1 mL of 0.02 N hydrochloric acid
to:
NMT 0.1 mL of 0.02 N sodium hydroxide

<670> AUXILIARY PACKAGING COMPONENTS

DESICCANTS/Silica Gel/Inorganic Impurities

USP39–NF34

510 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 1 of Soluble ionizable salts: Change
(as NaSO3):
to:
(as Na2SO4):


Line 1 of Soluble ionizable salts: Change
(as NaSO3):
to:
(as Na2SO4):

BETAXOLOL OPHTHALMIC SOLUTION

IMPURITIES/Organic Impurities

USP39–NF34

2749 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 14 of Analysis: Change
Mr1 = molecular weight of betaxolol hydrochloride, 343.89
Mr2 = molecular weight of betaxolol, 307.43
to:
Mr1 = molecular weight of betaxolol, 307.43
Mr2 = molecular weight of betaxolol hydrochloride, 343.89




Line 14 of Analysis: Change
Mr1 = molecular weight of betaxolol hydrochloride, 343.89
Mr2 = molecular weight of betaxolol, 307.43
to:
Mr1 = molecular weight of betaxolol, 307.43
Mr2 = molecular weight of betaxolol hydrochloride, 343.89

CARBIDOPA

ASSAY/Procedure

USP39–NF34

2924 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 3: Change
Mobile phase: Alcohol and 0.05 M monobasic sodium phosphate, adjusted with phosphoric acid to a pH of 2.7 (5:95)
to:
Buffer: 0.05 M monobasic sodium phosphate, adjusted with phosphoric acid to a pH of 2.7
Mobile phase: Alcohol and Buffer (5:95)



Line 3: Change
Mobile phase: Alcohol and 0.05 M monobasic sodium phosphate, adjusted with phosphoric acid to a pH of 2.7 (5:95)
to:
Buffer: 0.05 M monobasic sodium phosphate, adjusted with phosphoric acid to a pH of 2.7
Mobile phase: Alcohol and Buffer (5:95)

CHONDROITIN SULFATE SODIUM

IMPURITIES

USP39–NF34

6566 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 1 of Residue on Ignition <281>: Change
20.0%–30.0%
to:
20.0%–30.0% on the dried basis


Line 1 of Residue on Ignition <281>: Change
20.0%–30.0%
to:
20.0%–30.0% on the dried basis

CIPROFLOXACIN

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

Second Supplement to USP39–NF34

8597 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 2 of USP Ciprofloxacin Ethylenediamine Analog RS: Change
7-(2-Aminoethylamino)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid.
C15H16FN3O3 305.30
to:
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[(2-aminoethyl)amino]-3-quinolinecarboxylic acid hydrochloride.
C15H16FN3O3 · HCl 341.77




Line 2 of USP Ciprofloxacin Ethylenediamine Analog RS: Change
7-(2-Aminoethylamino)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid.
C15H16FN3O3 305.30
to:
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[(2-aminoethyl)amino]-3-quinolinecarboxylic acid hydrochloride.
C15H16FN3O3 · HCl 341.77

CIPROFLOXACIN HYDROCHLORIDE

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

Second Supplement to USP39–NF35

8600 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 2 of USP Ciprofloxacin Ethylenediamine Analog RS: Change
7-(2-Aminoethylamino)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid.
C15H16FN3O3 305.30
to:
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[(2-aminoethyl)amino]-3-quinolinecarboxylic acid hydrochloride.
C15H16FN3O3 · HCl 341.77




Line 2 of USP Ciprofloxacin Ethylenediamine Analog RS: Change
7-(2-Aminoethylamino)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid.
C15H16FN3O3 305.30
to:
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[(2-aminoethyl)amino]-3-quinolinecarboxylic acid hydrochloride.
C15H16FN3O3 · HCl 341.77

CYCLOBENZAPRINE HYDROCHLORIDE

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP39–NF34

3333 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 2 of USP Cyclobenzaprine Related Compound B RS: Change
3-(5H-Dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-1-propanamine.
C19H19N 261.36
to:
3-(5H-Dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-1-propanamine hydrochloride.
C19H19N · HCl 297.82




Line 2 of USP Cyclobenzaprine Related Compound B RS: Change
3-(5H-Dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-1-propanamine.
C19H19N 261.36
to:
3-(5H-Dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-1-propanamine hydrochloride.
C19H19N · HCl 297.82

DESMOPRESSIN ACETATE

IDENTIFICATION/A. Mass Spectral Analysis

USP39–NF34

3387 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 6 of Instrumental conditions: Delete
Flow rate: 0.7 mL/min
Injection volume: 10 µL/min

Line 6 of Instrumental conditions: Delete
Flow rate: 0.7 mL/min
Injection volume: 10 µL/min

DEXTROSE

IDENTIFICATION/C. Water Determination <921>

Second Supplement to USP39–NF34

8612 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 1: Change
Water Determination <921>
to:
Water Determination <921>, Method I


Line 1: Change
Water Determination <921>
to:
Water Determination <921>, Method I

DIGOXIN INJECTION

IDENTIFICATION/B.

USP39–NF34

3493 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 1 of Procedure: Change
Proceed as directed for Procedure in the test for Related glycosides under Digoxin, except to omit the use of the Gitoxin standard solution.
to:
Apply 10 µL of the Test solution and 10 µL of the Standard solution on a line parallel to and about 2.5 cm from the bottom edge of a reversed-phase thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture to which is permanently bonded octadecylsilane (C18). Allow the spots to dry, and place the plates in a developing chamber containing a mixture of methanol and water (7:3). Develop the chromatogram until the solvent front has moved about 15 cm above the line of application. Remove the plate, and allow the solvent to evaporate. Spray the plate with Chloramine T–trichloroacetic acid reagent, freshly mixed, and heat in an oven at 110° for 10 minutes.


Line 1 of Procedure: Change
Proceed as directed for Procedure in the test for Related glycosides under Digoxin, except to omit the use of the Gitoxin standard solution.
to:
Apply 10 µL of the Test solution and 10 µL of the Standard solution on a line parallel to and about 2.5 cm from the bottom edge of a reversed-phase thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture to which is permanently bonded octadecylsilane (C18).

Read more

DIGOXIN ORAL SOLUTION

IDENTIFICATION/B.

USP39–NF34

3493 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 1 of Procedure: Change
Proceed as directed for Procedure in the test for Related glycosides under Digoxin, except to omit the use of the Gitoxin standard solution.
to:
Apply 10 µL of the Test solution and 10 µL of the Standard solution on a line parallel to and about 2.5 cm from the bottom edge of a reversed-phase thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture to which is permanently bonded octadecylsilane (C18). Allow the spots to dry, and place the plates in a developing chamber containing a mixture of methanol and water (7:3). Develop the chromatogram until the solvent front has moved about 15 cm above the line of application. Remove the plate, and allow the solvent to evaporate. Spray the plate with Chloramine T–trichloroacetic acid reagent, freshly mixed, and heat in an oven at 110° for 10 minutes.


Line 1 of Procedure: Change
Proceed as directed for Procedure in the test for Related glycosides under Digoxin, except to omit the use of the Gitoxin standard solution.
to:
Apply 10 µL of the Test solution and 10 µL of the Standard solution on a line parallel to and about 2.5 cm from the bottom edge of a reversed-phase thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture to which is permanently bonded octadecylsilane (C18).

Read more

DIGOXIN TABLETS

IDENTIFICATION/A.

USP39–NF34

3494 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 1 of Procedure: Change
Proceed as directed for Procedure in the test for Related glycosides under Digoxin, except to omit the use of the Gitoxin standard solution.
to:
Apply 10 µL of the Test solution and 10 µL of the Standard solution on a line parallel to and about 2.5 cm from the bottom edge of a reversed-phase thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture to which is permanently bonded octadecylsilane (C18). Allow the spots to dry, and place the plates in a developing chamber containing a mixture of methanol and water (7:3). Develop the chromatogram until the solvent front has moved about 15 cm above the line of application. Remove the plate, and allow the solvent to evaporate. Spray the plate with Chloramine T–trichloroacetic acid reagent, freshly mixed, and heat in an oven at 110° for 10 minutes.


Line 1 of Procedure: Change
Proceed as directed for Procedure in the test for Related glycosides under Digoxin, except to omit the use of the Gitoxin standard solution.
to:
Apply 10 µL of the Test solution and 10 µL of the Standard solution on a line parallel to and about 2.5 cm from the bottom edge of a reversed-phase thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture to which is permanently bonded octadecylsilane (C18).

Read more

DUTASTERIDE

IMPURITIES/Organic Impurities, Procedure 2/Table 4

USP40–NF35

3924 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Footnote a: Change
(5α,17β)-N-[2,5-Bis(trifluoromethyl)phenyl]-3-oxo-4-azaandrost-17 carboxamide.
to:
(5α,17β)-N-[2,5-Bis(trifluoromethyl)phenyl]-3-oxo-4-azaandrostane-17-carboxamide.


Footnote a: Change
(5α,17β)-N-[2,5-Bis(trifluoromethyl)phenyl]-3-oxo-4-azaandrost-17 carboxamide.
to:
(5α,17β)-N-[2,5-Bis(trifluoromethyl)phenyl]-3-oxo-4-azaandrostane-17-carboxamide.

GUAR GUM

ASSAY/Content of Galactomannan and Ratio of Constituting Mannose and Galactose

First Supplement to USP39–NF34

7964 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 4 of Analysis: Change
Standard solution B
to:
Sample solution B


Line 4 of Analysis: Change
Standard solution B
to:
Sample solution B

MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS

IMPURITIES/Organic Impurities/Table 6

First Supplement to USP39–NF34

8101 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Footnote c: Change
(4R,4aS,5aR,12aS)-4-Dimethylamino-3,10,12,12a-tetrahydroxy-7-methylamino-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide.
to:
(4S,4aS,5aR,12aS)-4-Dimethylamino-3,10,12,12a-tetrahydroxy-7-methylamino-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide.


Footnote c: Change
(4R,4aS,5aR,12aS)-4-Dimethylamino-3,10,12,12a-tetrahydroxy-7-methylamino-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide.
to:
(4S,4aS,5aR,12aS)-4-Dimethylamino-3,10,12,12a-tetrahydroxy-7-methylamino-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide.

NAPHAZOLINE HYDROCHLORIDE

IMPURITIES/Organic Impurities

First Supplement to USP39–NF34

8105 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 16 of Analysis: Change
Calculate the percentage of any individual unspecified impurity
to:
Calculate the percentage of any other individual impurity
AND
Line 20 of Analysis: Change
rU = peak response of any individual unspecified impurity
to:
rU = peak response of any other individual impurity







Line 16 of Analysis: Change
Calculate the percentage of any individual unspecified impurity
to:
Calculate the percentage of any other individual impurity
AND
Line 20 of Analysis: Change
rU = peak response of any individual unspecified impurity
to:
rU = peak response of any other individual impurity

OMEGA-3-ACID ETHYL ESTERS CAPSULES

ASSAY/Content of EPAee, DHAee, and Total Omega-3-Acid Ethyl Esters

Second Supplement to USP39–NF34

8755 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 21 of Analysis: Change
CU = nominal concentration of the total omega-3-acid ethyl esters in the Sample solution (g/mL)
to:
CU = Capsule fill content of the Sample solution (g/mL)


Line 21 of Analysis: Change
CU = nominal concentration of the total omega-3-acid ethyl esters in the Sample solution (g/mL)
to:
CU = Capsule fill content of the Sample solution (g/mL)

OMEGA-3-ACID ETHYL ESTERS CAPSULES

SPECIFIC TESTS/Concentration of Omega-3-Acid Ethyl Esters

Second Supplement to USP39–NF34

8755 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 21: Change
CU = nominal concentration of the total omega-3-acid ethyl esters in the Sample solution (g/mL)
to:
CU = Capsule fill content of the Sample solution (g/mL)


Line 21: Change
CU = nominal concentration of the total omega-3-acid ethyl esters in the Sample solution (g/mL)
to:
CU = Capsule fill content of the Sample solution (g/mL)

POVIDONE

IMPURITIES/Formic Acid

Second Supplement to USP39–NF34

8778 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 3 of Sample solution: Change
column of about 80 mm
to:
column of about 8 mm


Line 3 of Sample solution: Change
column of about 80 mm
to:
column of about 8 mm

POWDERED CHASTE TREE EXTRACT

CONTAMINANTS

USP39–NF34

6553 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Change
Microbial Enumeration Tests <2021>: The total bacterial count does not exceed 104 cfu/g. The total combined molds and yeasts count does not exceed 1000 cfu/g. It meets the requirements of the tests for absence of Salmonella species and Escherichia coli.
to:
Microbial Enumeration Tests <2021>: The total bacterial count does not exceed 104 cfu/g. The total combined molds and yeasts count does not exceed 103 cfu/g.
Absence of Specified Microorganisms <2022>: Meets the requirements of the tests for absence of Salmonella species and Escherichia coli



Change
Microbial Enumeration Tests <2021>: The total bacterial count does not exceed 104 cfu/g. The total combined molds and yeasts count does not exceed 1000 cfu/g. It meets the requirements of the tests for absence of Salmonella species and Escherichia coli.
to:
Microbial Enumeration Tests <2021>: The total bacterial count does not exceed 104 cfu/g.

Read more

RIBOFLAVIN 5′-PHOSPHATE SODIUM

ASSAY/Procedure

USP39–NF34

5698 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 2 of Instrumental conditions: Change
Nephelometry, Turbidimetry, and Visual Comparison <855>
to:
Fluorescence Spectroscopy <853>


Line 2 of Instrumental conditions: Change
Nephelometry, Turbidimetry, and Visual Comparison <855>
to:
Fluorescence Spectroscopy <853>

ROPINIROLE EXTENDED-RELEASE TABLETS

PERFORMANCE TESTS/Dissolution <711>/Test 1

Second Supplement to USP39–NF34

8814 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 2 of Buffer 1: Adjust with Solution A to a pH of 4.0.
to:
Adjust with Solution A to a pH of 4.0. Dilute with water to 1 L.

Line 2 of Buffer 1: Adjust with Solution A to a pH of 4.0.
to:
Adjust with Solution A to a pH of 4.0. Dilute with water to 1 L.

SUCCINYLCHOLINE CHLORIDE INJECTION

IDENTIFICATION

USP39–NF34

5922 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 1: Change
It responds to Identification tests B and C under Succinylcholine Chloride.
to:
A. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
B. Thin-Layer Chromatographic Identification Test <201>
Standard solution: 1 mg/mL of USP Succinylcholine Chloride RS in water
Sample solution: Nominally 1 mg/mL of succinylcholine chloride from Injection in water
Chromatographic system
(See Chromatography <621>, Thin-Layer Chromatography.)
Adsorbent: 0.25-mm layer of chromatographic silica gel
Application volume: 1 µL
Developing solvent system: Acetone and 1 N hydrochloric acid (1:1)
Analysis
Samples: Standard solution and Sample solution
Proceed as directed in the chapter. To locate the spots, heat the plate at 105° for 5 min, cool, and spray with potassium bismuth iodide TS, then heat again at 105° for 5 min.
Acceptance criteria: Meets the requirements














Line 1: Change
It responds to Identification tests B and C under Succinylcholine Chloride.
to:
A. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
B.

Read more

<1010> ANALYTICAL DATA—INTERPRETATION AND TREATMENT

APPENDIX C: EXAMPLES OF OUTLIER TESTS FOR ANALYTICAL DATA/Hampel's Rule

USP39–NF34

767 01-Oct-2016

USP41–NF36

First Supplement to USP40–NF35

Row 13 of Column 4 of Table 5. Test Results of Re-Applied Hampel's Rule: Change
0.14
to:
0.15


Row 13 of Column 4 of Table 5. Test Results of Re-Applied Hampel's Rule: Change
0.14
to:
0.15

<800> HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS

REFERENCES

First Supplement to USP39–NF34

7721 01-Oct-2016

USP41–NF36

First Supplement to USP40–NF35

<800> HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS

APPENDICES/Appendix 3: Types of Biological Safety Cabinets/Class II

First Supplement to USP39–NF34

7721 01-Oct-2016

USP41–NF36

First Supplement to USP40–NF35

Line 5 of Type A1 (formerly, Type A): Change
radionucleotides
to:
radionuclides
AND
Line 5 of Type A2 (formerly, Type B3): Change
radionucleotides
to:
radionuclides
AND
Line 5 of Type B1: Change
radionucleotides
to:
radionuclides
AND
Line 5 of Type B2 (total exhaust): Change
radionucleotides
to:
radionuclides

















Line 5 of Type A1 (formerly, Type A): Change
radionucleotides
to:
radionuclides
AND
Line 5 of Type A2 (formerly, Type B3): Change
radionucleotides
to:
radionuclides
AND
Line 5 of Type B1: Change
radionucleotides
to:
radionuclides
AND
Line 5 of Type B2 (total exhaust): Change
radionucleotides
to:
radionuclides

CALCIUM GLUCONATE

CHEMICAL INFORMATION

USP39–NF34

2877 01-Oct-2016

USP41–NF36

First Supplement to USP40–NF35

Line 5: Change
[18016-24-5].
to:
[66905-23-5].


Line 5: Change
[18016-24-5].
to:
[66905-23-5].

CALCIUM GLUCONATE INJECTION

DEFINITION

USP39–NF34

2879 01-Oct-2016

USP41–NF36

First Supplement to USP40–NF35

Line 8: Change
It may contain sodium hydroxide added for adjustment of the pH.
to:
It may contain sodium hydroxide or hydrochloric acid added for adjustment of the pH.


Line 8: Change
It may contain sodium hydroxide added for adjustment of the pH.
to:
It may contain sodium hydroxide or hydrochloric acid added for adjustment of the pH.

DANTROLENE SODIUM

IDENTIFICATION/D.

First Supplement to USP39–NF34

8035 01-Oct-2016

USP41–NF36

First Supplement to USP40–NF35

Line 2 of Solution A: Change
tetramethylammonium hydroxide solution
to:
tetramethylammonium hydroxide TS


Line 2 of Solution A: Change
tetramethylammonium hydroxide solution
to:
tetramethylammonium hydroxide TS

DESLORATADINE

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

Second Supplement to USP39–NF34

8607 01-Oct-2016

USP41–NF36

First Supplement to USP40–NF35

Line 2 of USP Desloratadine Related Compound B RS: Change
8-Chloro-11-(1,2,3,6-tetrahydropyridin-4-yl)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine.
C19H19ClN2 310.82
to:
8-Chloro-11-(1,2,3,6-tetrahydropyridin-4-yl)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine hydrochloride.
C19H20Cl2N2 347.28




Line 2 of USP Desloratadine Related Compound B RS: Change
8-Chloro-11-(1,2,3,6-tetrahydropyridin-4-yl)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine.
C19H19ClN2 310.82
to:
8-Chloro-11-(1,2,3,6-tetrahydropyridin-4-yl)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine hydrochloride.
C19H20Cl2N2 347.28

FLUORESCEIN SODIUM

ASSAY/Procedure

USP39–NF34

3960 01-Oct-2016

USP41–NF36

First Supplement to USP40–NF35

Line 3 of Standard stock solution: Change
1.0 mg/mL of fluorescein sodium in Diluent is prepared as follows.
to:
1.0 mg/mL of fluorescein sodium is prepared as follows.


Line 3 of Standard stock solution: Change
1.0 mg/mL of fluorescein sodium in Diluent is prepared as follows.
to:
1.0 mg/mL of fluorescein sodium is prepared as follows.

NORFLOXACIN

SPECIFIC TESTS/Loss on Drying <731>

USP39–NF34

5101 01-Oct-2016

USP41–NF36

First Supplement to USP40–NF35

Line 1 of Analysis: Change
Dry at 100° to constant weight.
to:
Dry under vacuum at a pressure not exceeding 5 mm of mercury at 100° to constant weight.


Line 1 of Analysis: Change
Dry at 100° to constant weight.
to:
Dry under vacuum at a pressure not exceeding 5 mm of mercury at 100° to constant weight.

OXYMETAZOLINE HYDROCHLORIDE

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

First Supplement to USP39–NF34

8116 01-Oct-2016

USP41–NF36

First Supplement to USP40–NF35

USP Oxymetazoline Related Compound A RS: Change
N-(2-Aminoethyl)-2-[4-(tert-butyl)-3-hydroxy-2,6-dimethylphenyl]acetamide.
C16H26N2O2 278.39
to:
N-(2-Aminoethyl)-2-[4-(tert-butyl)-3-hydroxy-2,6-dimethylphenyl]acetamide hydrochloride.
C16H26N2O2 · HCl 314.85




USP Oxymetazoline Related Compound A RS: Change
N-(2-Aminoethyl)-2-[4-(tert-butyl)-3-hydroxy-2,6-dimethylphenyl]acetamide.
C16H26N2O2 278.39
to:
N-(2-Aminoethyl)-2-[4-(tert-butyl)-3-hydroxy-2,6-dimethylphenyl]acetamide hydrochloride.
C16H26N2O2 · HCl 314.85

OXYMETAZOLINE HYDROCHLORIDE

IMPURITIES/Organic Impurities/Table 2

First Supplement to USP39–NF34

8116 01-Oct-2016

USP41–NF36

First Supplement to USP40–NF35

Row 2 of Column 1: Change
Oxymetazoline related compound A
to:
Oxymetazoline related compound Aa
AND
Add footnote a:
N-(2-Aminoethyl)-2-[4-(tert-butyl)-3-hydroxy-2,6-dimethylphenyl]acetamide.





Row 2 of Column 1: Change
Oxymetazoline related compound A
to:
Oxymetazoline related compound Aa
AND
Add footnote a:
N-(2-Aminoethyl)-2-[4-(tert-butyl)-3-hydroxy-2,6-dimethylphenyl]acetamide.

PARICALCITOL INJECTION

IMPURITIES/Organic Impurities/Chromatographic system/Columns

USP39–NF34

5279 01-Oct-2016

USP41–NF36

First Supplement to USP40–NF35

Line 1 of Guard: Change
4.6-mm × 7.5-mm; packing L1
to:
4.6-mm × 7.5-mm or 4.6-mm × 10-mm; packing L1


Line 1 of Guard: Change
4.6-mm × 7.5-mm; packing L1
to:
4.6-mm × 7.5-mm or 4.6-mm × 10-mm; packing L1

PERINDOPRIL ERBUMINE

CHEMICAL INFORMATION

First Supplement to USP39–NF34

8127 01-Oct-2016

USP41–NF36

First Supplement to USP40–NF35

Line 9: Delete
(2S,3aS,7aS)-1-{(S)-2-[(R)-1-Ethoxy-1-oxopentan-2-ylamino]propanoyl}octahydro-1H-indole-2-carboxylic acid

Line 9: Delete
(2S,3aS,7aS)-1-{(S)-2-[(R)-1-Ethoxy-1-oxopentan-2-ylamino]propanoyl}octahydro-1H-indole-2-carboxylic acid

PERINDOPRIL ERBUMINE

IMPURITIES/Organic Impurities/Table 2

First Supplement to USP39–NF34

8127 01-Oct-2016

USP41–NF36

First Supplement to USP40–NF35

Line 2 of footnote g: Change
ocatahydro
to:
octahydro


Line 2 of footnote g: Change
ocatahydro
to:
octahydro

PERINDOPRIL ERBUMINE

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

First Supplement to USP39–NF34

8127 01-Oct-2016

USP41–NF36

First Supplement to USP40–NF35

Line 2 of USP Perindopril Related Compound A RS: Change
(2S,3aS,7aS)-Octahydro-1H-indole-2-carboxylic acid hydrochloride.
C17H28N2O5 · HCl 205.68
to:
(2S,3aS,7aS)-Octahydro-1H-indole-2-carboxylic acid.
C9H15NO2 169.22




Line 2 of USP Perindopril Related Compound A RS: Change
(2S,3aS,7aS)-Octahydro-1H-indole-2-carboxylic acid hydrochloride.
C17H28N2O5 · HCl 205.68
to:
(2S,3aS,7aS)-Octahydro-1H-indole-2-carboxylic acid.
C9H15NO2 169.22

PHENYTOIN SODIUM

IDENTIFICATION/B. Identification Tests—General, Sodium <191>

USP39–NF34

5388 01-Oct-2016

USP41–NF36

First Supplement to USP40–NF35

Line 2: Change
tetramethylammonium hydroxide solution,
to:
tetramethylammonium hydroxide TS,


Line 2: Change
tetramethylammonium hydroxide solution,
to:
tetramethylammonium hydroxide TS,

POTASSIUM CITRATE EXTENDED-RELEASE TABLETS

OTHER COMPONENTS/Content of Potassium

USP39–NF34

5465 01-Oct-2016

USP41–NF36

First Supplement to USP40–NF35

Line 10 of Analysis: Change
Result = (C/CU) × [Mr/(3 × Ar)] × 100
to:
Result = C × 100/CU
AND
Line 13 of Analysis: Change
CU = nominal concentration, based on the Assay value, of potassium citrate monohydrate in the Sample solution (µg/mL)
Mr = molecular weight of potassium citrate monohydrate, 324.41
Ar = atomic weight of potassium, 39.10
to:
CU = concentration of potassium citrate anhydrous (C6H5K3O7) in the Sample solution calculated from the Assay value of potassium citrate monohydrate (C6H5K3O7 · H2O) (µg/mL)









Line 10 of Analysis: Change
Result = (C/CU) × [Mr/(3 × Ar)] × 100
to:
Result = C × 100/CU
AND
Line 13 of Analysis: Change
CU = nominal concentration, based on the Assay value, of potassium citrate monohydrate in the Sample solution (µg/mL)
Mr = molecular weight of potassium citrate monohydrate, 324.41
Ar = atomic weight of potassium, 39.10
to:

Read more

PROPOFOL

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP39–NF34

5573 01-Oct-2016

USP41–NF36

First Supplement to USP40–NF35

Line 2 of USP Propofol Related Compound B RS: Change
2,6-Diisopropylbenzoquinone.
to:
2,6-Diisopropyl-1,4-benzoquinone.


Line 2 of USP Propofol Related Compound B RS: Change
2,6-Diisopropylbenzoquinone.
to:
2,6-Diisopropyl-1,4-benzoquinone.

PROPOFOL INJECTABLE EMULSION

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP39–NF34

5575 01-Oct-2016

USP41–NF36

First Supplement to USP40–NF35

Line 2 of USP Propofol Related Compound B RS: Change
2,6-Diisopropylbenzoquinone.
to:
2,6-Diisopropyl-1,4-benzoquinone.


Line 2 of USP Propofol Related Compound B RS: Change
2,6-Diisopropylbenzoquinone.
to:
2,6-Diisopropyl-1,4-benzoquinone.

ST. JOHN'S WORT

SPECIFIC TESTS

USP39–NF34

6817 01-Oct-2016

USP41–NF36

First Supplement to USP40–NF35

Insert missing test:
Articles of Botanical Origin <561>, Methods of Analysis, Total Ash: NMT 5.0%

Insert missing test:
Articles of Botanical Origin <561>, Methods of Analysis, Total Ash: NMT 5.0%

TRAVOPROST OPHTHALMIC SOLUTION

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP39–NF34

6226 01-Oct-2016

USP41–NF36

First Supplement to USP40–NF35

Line 2 of USP Travoprost Related Compound A RS: Change
(5Z,13E)-(9S,11R,15R)-9,11,15-Trihydroxy-16-(m-trifluoromethylphenoxy)-17,18,19,20-tetranor-5,13-prostadienoic acid.
to:
(5Z,13E)-(9S,11R,15R)-9,11,15-Trihydroxy-16-(m-trifluoromethylphenoxy)-17,18,19,20-tetranor-5,13-prostadienoic acid
or
(Z)-7-((1R,2R,3R,5S)-3,5-Dihydroxy-2-{(R,E)-3-hydroxy-4-[3-(trifluoromethyl)phenoxy]but-1-enyl}cyclopentyl)hept-5-enoic acid.




Line 2 of USP Travoprost Related Compound A RS: Change
(5Z,13E)-(9S,11R,15R)-9,11,15-Trihydroxy-16-(m-trifluoromethylphenoxy)-17,18,19,20-tetranor-5,13-prostadienoic acid.

Read more

VITAMIN A ORAL LIQUID PREPARATION

ASSAY/Vitamin A

USP39–NF34

6374 01-Oct-2016

USP41–NF36

First Supplement to USP40–NF35

Line 7 of Analysis: Change
Result = (rU/rS) × (C/W) × (V/D) × U × (100/L)
to:
Result = (rU/rS) × (C/W) × D × U × (100/L)
AND
Line 16 of the Analysis: Delete
V = volume of the Sample solution (mL)





Line 7 of Analysis: Change
Result = (rU/rS) × (C/W) × (V/D) × U × (100/L)
to:
Result = (rU/rS) × (C/W) × D × U × (100/L)
AND
Line 16 of the Analysis: Delete
V = volume of the Sample solution (mL)

<1663> EXTRACTABLES ASSOCIATED WITH PHARMACEUTICAL PACKAGING SYSTEMS

REFERENCES

USP39–NF34

1835 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Delete references 5, 7, 9, and 12.

Delete references 5, 7, 9, and 12.

<1664> ASSESSMENT OF DRUG PRODUCT LEACHABLES ASSOCIATED WITH PHARMACEUTICAL PACKAGING/DELIVERY SYSTEMS

REFERENCES

USP39–NF34

1850 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Delete reference 8.

Delete reference 8.

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