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

<1056> BIOTECHNOLOGY-DERIVED ARTICLES -- POLYACRYLAMIDE GEL ELECTROPHORESIS

INTRODUCTION

Harmonization (Official December 01, 2015)

ONLINE 01-Aug-2015

USP40–NF35

First Supplement to USP39–NF34

A paragraph before the Introduction was deleted:
This chapter provides guidance and procedures used for characterization of biotechnology-derived articles by polyacrylamide gel electrophoresis. Portions of the chapter that are not harmonized with the other two pharmacopeias are marked by the symbol ♦. This chapter is harmonized with the corresponding chapter in JP and EP. Other characterization tests, also harmonized, are shown in Biotechnology-Derived Articles—Amino Acid Analysis <1052>, Biotechnology-Derived Articles—Capillary Electrophoresis <1053>, Biotechnology-Derived Articles—Isoelectric Focusing <1054>, Biotechnology-Derived Articles—Peptide Mapping <1055>, and Biotechnology-Derived Articles—Total Protein Assay <1057>.

A paragraph before the Introduction was deleted:

Read more

ALMOTRIPTAN MALATE

IMPURITIES/Limit of Almotriptan Related Compound D and Almotriptan N-Dimer

First Supplement to USP38–NF33

7325 01-Aug-2015

USP40–NF35

First Supplement to USP39–NF34

Line 1
of Internal standard solution: Change
4-hydroxy-phenylpiperidine
to:
4-hydroxy-4-phenylpiperidine

Line 1
of Internal standard solution: Change
4-hydroxy-phenylpiperidine
to:
4-hydroxy-4-phenylpiperidine

AMOXICILLIN TABLETS FOR ORAL SUSPENSION

ASSAY/Procedure

USP38–NF33

2225 01-Aug-2015

USP40–NF35

First Supplement to USP39–NF34

Line 6 of Analysis: Change
Result = (rU
/rS
) × (CS
/CU
) × P × (1/F) ×

100

to:
Result = (rU
/rS
) × (CS
/CU
) × P ×
F × 100

Line 6 of Analysis: Change
Result = (rU
/rS
) × (CS
/CU
) × P × (1/F) ×

100

to:
Result = (rU
/rS
) × (CS
/CU
) × P ×
F × 100

DOXAZOSIN MESYLATE

IMPURITIES/Organic Impurities/Analysis

First Supplement to USP38–NF33

7387 01-Aug-2015

USP40–NF35

First Supplement to USP39–NF34

Line 3 of the variable definition list: Change
rS
= peak response of each impurity from the Standard solution

to:
rS

= peak response of each impurity or doxazosin mesylate (for calculating unspecified impurities) from the Standard solution

AND
Line 5 of the variable definition list: Change
CS
= concentration of USP Doxazosin Mesylate RS in the Standard solution (mg/mL)

to:
CS

= concentration of the corresponding USP Doxazosin Related Compound RS or USP Doxazosin Mesylate RS (for calculating unspecified impurities) in the Standard solution (mg/mL)

Line 3 of the variable definition list: Change
rS
= peak response of each impurity from the Standard solution

to:
rS

= peak response of each impurity or doxazosin mesylate (for calculating unspecified impurities) from the Standard solution

AND
Line 5 of the variable definition list: Change
CS
= concentration of USP Doxazosin Mesylate RS in the Standard solution (mg/mL)

to:
CS

Read more

ESTRADIOL AND NORETHINDRONE ACETATE TABLETS

IMPURITIES/Organic Impurities/Procedure/System suitability

USP38–NF33

3385 01-Aug-2015

USP40–NF35

First Supplement to USP39–NF34

Line 2 of the Note: Change
1.0, 1.4, and 3.0,
to:
1.0, 1.1, and 1.7,

Line 2 of the Note: Change
1.0, 1.4, and 3.0,
to:
1.0, 1.1, and 1.7,

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER

DEFINITION

USP38–NF33

6753 01-Aug-2015

USP40–NF35

First Supplement to USP39–NF34

Line 4: Change
Methacrylic acid units in Methacrylic Acid and Ethyl Acrylate Copolymer are NLT 46.0% and NMT 50.6%, calculated on the dried basis.
to:
Methacrylic acid units in Methacrylic Acid and Ethyl Acrylate Copolymer, previously dried, are NLT 46.0% and NMT 50.6%.

Line 4: Change
Methacrylic acid units in Methacrylic Acid and Ethyl Acrylate Copolymer are NLT 46.0% and NMT 50.6%, calculated on the dried basis.
to:
Methacrylic acid units in Methacrylic Acid and Ethyl Acrylate Copolymer, previously dried, are NLT 46.0% and NMT 50.6%.

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER

ASSAY/Procedure

USP38–NF33

6753 01-Aug-2015

USP40–NF35

First Supplement to USP39–NF34

Line 1 of Acceptance criteria: Delete
on the dried basis

Line 1 of Acceptance criteria: Delete
on the dried basis

METHACRYLIC ACID AND METHYL METHACRYLATE COPOLYMER

DEFINITION

USP38–NF33

6755 01-Aug-2015

USP40–NF35

First Supplement to USP39–NF34

Methacrylic acid units in Methacrylic Acid and Methyl Methacrylate Copolymer are NLT 27.6% and NMT 50.6%, calculated on the dried basis.
to:
Methacrylic acid units in Methacrylic Acid and Methyl Methacrylate
Copolymer, previously dried, are NLT 27.6% and NMT 50.6%.

Methacrylic acid units in Methacrylic Acid and Methyl Methacrylate Copolymer are NLT 27.6% and NMT 50.6%, calculated on the dried basis.
to:
Methacrylic acid units in Methacrylic Acid and Methyl Methacrylate
Copolymer, previously dried, are NLT 27.6% and NMT 50.6%.

METHACRYLIC ACID AND METHYL METHACRYLATE COPOLYMER

ASSAY/Procedure

USP38–NF33

6755 01-Aug-2015

USP40–NF35

First Supplement to USP39–NF34

Line 3 of Acceptance criteria: Delete
on the dried basis
AND
Line 5 of Acceptance criteria: Delete
on the dried basis

Line 3 of Acceptance criteria: Delete
on the dried basis
AND
Line 5 of Acceptance criteria: Delete
on the dried basis

METHOTREXATE

IMPURITIES/Organic Impurities/Procedure 1: Related Compounds

USP38–NF33

4318 01-Aug-2015

USP40–NF35

First Supplement to USP39–NF34

Line 15 of Analysis: Change
methotrexate related compound E free acid

to:
methotrexate related compound E free base
AND

Line 8 of the second variable definition list for Analysis: Change
methotrexate related compound E free acid

to:
methotrexate related compound E free base
AND
Row 5 of Column 1 of Impurity Table 1: Change
Methotrexate related compound E free acidc

to:
Methotrexate related compound E free basec

Line 15 of Analysis: Change
methotrexate related compound E free acid

to:
methotrexate related compound E free base
AND

Line 8 of the second variable definition list for Analysis: Change
methotrexate related compound E free acid

to:
methotrexate related compound E free base
AND
Row 5 of Column 1 of Impurity Table 1: Change
Methotrexate related compound E free acidc

to:
Methotrexate related compound E free basec

METOLAZONE TABLETS

ASSAY/Procedure

USP38–NF33

4368 01-Aug-2015

USP40–NF35

First Supplement to USP39–NF34

Change the subsection
Standard solution: 5 µg/mL of USP Metolazone RS in methanol

to:
Standard stock solution: 0.25 mg/mL of USP Metolazone RS in methanol

Standard solution: 5 µg/mL of USP Metolazone RS in Mobile phase from Standard stock solution

AND
Line 2 of Sample solution: Change
of metolazone from the Sample stock solution in methanol

to:
of metolazone in Mobile phase from the Sample stock solution

Change the subsection
Standard solution: 5 µg/mL of USP Metolazone RS in methanol

to:
Standard stock solution: 0.25 mg/mL of USP Metolazone RS in methanol

Standard solution: 5 µg/mL of USP Metolazone RS in Mobile phase from Standard stock solution

AND
Line 2 of Sample solution: Change
of metolazone from the Sample stock solution in methanol

to:
of metolazone in Mobile phase from the Sample stock solution

OXAPROZIN TABLETS

IMPURITIES/Organic Impurities/System suitability/Suitability requirements

USP38–NF33

4681 01-Aug-2015

USP40–NF35

First Supplement to USP39–NF34

Delete the subsection
Signal-to-noise ratio: NLT 3000

Delete the subsection
Signal-to-noise ratio: NLT 3000

PURIFIED STEARIC ACID

ASSAY/Procedure/System suitability/Suitability requirements

USP38–NF33

6919 01-Aug-2015

USP40–NF35

First Supplement to USP39–NF34

Line 2 of Relative standard deviation: Change
six replicate injections of Sample solution;
to:
six replicate injections;

Line 2 of Relative standard deviation: Change
six replicate injections of Sample solution;
to:
six replicate injections;

STEARIC ACID

ASSAY/Procedure/System suitability/Suitability requirements

Harmonization (Official May 01, 2015)

ONLINE 01-Aug-2015

USP40–NF35

First Supplement to USP39–NF34

Line 3 of Relative standard deviation: Change
peaks (from six replicate injections of Sample solution);
to:
peaks, from six replicate injections;

Line 3 of Relative standard deviation: Change
peaks (from six replicate injections of Sample solution);
to:
peaks, from six replicate injections;

TETRACAINE HYDROCHLORIDE FOR INJECTION

Identification

USP38–NF33

5508 01-Aug-2015

USP40–NF35

First Supplement to USP39–NF34

Line 1 of B: Change
It responds to Identification test B under Tetracaine Hydrochloride.
to:
Dissolve 100 mg in 10 mL of water, and add 1 mL of potassium thiocyanate solution (1 in 4): a crystalline precipitate is formed. Recrystallize the precipitate from water, and dry at 80° for 2 hours: it melts between 130° and 132°.

Line 1 of B: Change
It responds to Identification test B under Tetracaine Hydrochloride.
to:
Dissolve 100 mg in 10 mL of water, and add 1 mL of potassium thiocyanate solution (1 in 4): a crystalline precipitate is formed. Recrystallize the precipitate from water, and dry at 80° for 2 hours: it melts between 130° and 132°.

TETRACAINE HYDROCHLORIDE FOR INJECTION

Chromatographic purity

USP38–NF33

5508 01-Aug-2015

USP40–NF35

First Supplement to USP39–NF34

Line 1: Change
Dissolve an accurately weighed quantity of Tetracaine Hydrochloride for Injection in water to obtain a test solution containing 50 mg per mL, and proceed as directed in the test for Chromatographic purity under Tetracaine, beginning with “Prepare a Standard solution.”

to:
Dissolve an accurately weighed quantity of Tetracaine Hydrochloride for Injection in water to obtain a test solution containing 50 mg per mL.
Prepare a Standard solution of 4-(butylamino) benzoic acid in methanol containing 0.2 mg per mL. Apply separate 5-µL portions of the test solution and the Standard solution to a suitable thin-layer chromatographic plate (see Chromatography <621>) coated with a 0.25-mm layer of chromatographic silica gel mixture. Develop the plate in a suitable chromatographic chamber containing a solvent system consisting of a mixture of chloroform, methanol, and isopropylamine (98:7:2) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, and dry in a current of warm air. Examine the plate under short-wavelength UV light: any spot obtained from the test solution, other than the principal spot, is not more intense than the principal spot obtained from the Standard solution (0.4%), and the sum of the intensities of any such spots is not greater than 0.8%.

Line 1: Change
Dissolve an accurately weighed quantity of Tetracaine Hydrochloride for Injection in water to obtain a test solution containing 50 mg per mL, and proceed as directed in the test for Chromatographic purity under Tetracaine, beginning with “Prepare a Standard solution.”

Read more

TETRACAINE HYDROCHLORIDE IN DEXTROSE INJECTION

Identification

USP38–NF33

5509 01-Aug-2015

USP40–NF35

First Supplement to USP39–NF34

Line 1 of B: Change
It responds to Identification test C under Tetracaine Hydrochloride.
to:
A solution of 100 mg in 5 mL of water meets the requirements of the tests for Chloride <191>.

Line 1 of B: Change
It responds to Identification test C under Tetracaine Hydrochloride.
to:
A solution of 100 mg in 5 mL of water meets the requirements of the tests for Chloride <191>.

TETRACAINE HYDROCHLORIDE INJECTION

Identification

USP38–NF33

5507 01-Aug-2015

USP40–NF35

First Supplement to USP39–NF34

Line 1 of A: Change
It responds to Identification test B under Tetracaine Hydrochloride.
to:
Dissolve 100 mg in 10 mL of water, and add 1 mL of potassium thiocyanate solution (1 in 4): a crystalline precipitate is formed. Recrystallize the precipitate from water, and dry at 80° for 2 hours: it melts between 130° and 132°.

Line 1 of A: Change
It responds to Identification test B under Tetracaine Hydrochloride.
to:
Dissolve 100 mg in 10 mL of water, and add 1 mL of potassium thiocyanate solution (1 in 4): a crystalline precipitate is formed. Recrystallize the precipitate from water, and dry at 80° for 2 hours: it melts between 130° and 132°.

<1047> GENE THERAPY PRODUCTS

REGULATIONS AND STANDARDS

USP38–NF33

883 01-Jun-2015

USP39–NF34

USP39–NF34

Line 8: Delete
and, in particular, www.fda.gov/cber/publications.htm

Line 8: Delete
and, in particular, www.fda.gov/cber/publications.htm

<1047> GENE THERAPY PRODUCTS

APPENDIX

USP38–NF33

883 01-Jun-2015

USP39–NF34

USP39–NF34

Line 8 of National and International Regulatory Documents: Delete
(http://www4.od.nih.gov/oba/guidelines.html)

Line 8 of National and International Regulatory Documents: Delete
(http://www4.od.nih.gov/oba/guidelines.html)

<1197> GOOD DISTRIBUTION PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS

SECTION 2: QUALITY, ORGANIZATION, AND DOCUMENTATION/2.8 Contract Activities

USP38–NF33

1396 01-Jun-2015

USP39–NF34

USP39–NF34

<1197> GOOD DISTRIBUTION PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS

SECTION 4: RETURNED GOODS, DISPATCH, TRANSPORT, IMPORTATION, ADULTERATION, AND TRACEABILITY/4.7 Importation

USP38–NF33

1396 01-Jun-2015

USP39–NF34

USP39–NF34

<232> ELEMENTAL IMPURITIES--LIMITS

DRUG SUBSTANCE AND EXCIPIENTS/Table 2

Second Supplement to USP38–NF33

7594 01-Jun-2015

USP39–NF34

USP39–NF34

Line 1 of Row 1 of Column 2: Change
(g/g)
to:
(µg/g)
AND
Line 1 of Row 1 of Column 3: Change
(g/g)
to:
(µg/g)
AND
Line 1 of Row 1 of Column 4: Change
(g/g)
to:
(µg/g)

Line 1 of Row 1 of Column 2: Change
(g/g)
to:
(µg/g)
AND
Line 1 of Row 1 of Column 3: Change
(g/g)
to:
(µg/g)
AND
Line 1 of Row 1 of Column 4: Change
(g/g)
to:
(µg/g)

ALUMINUM CHLOROHYDRATE

CHEMICAL INFORMATION

USP38–NF33

2130 01-Jun-2015

USP39–NF34

USP39–NF34

Line 8: Change
Dihydrate [12042-91-0].
Anhydrous [1327-41-9].
to:
Dihydrate [12359-72-7].
Anhydrous [12042-91-0].

Line 8: Change
Dihydrate [12042-91-0].
Anhydrous [1327-41-9].
to:
Dihydrate [12359-72-7].
Anhydrous [12042-91-0].

AZATHIOPRINE

ASSAY/Procedure

USP38–NF33

2334 01-Jun-2015

USP39–NF34

USP39–NF34

Line 1 of Standard stock solution: Change
0.1 mg/mL of USP Azathioprine RS prepared as follows.
to:
0.5 mg/mL of USP Azathioprine RS prepared as follows.

Line 1 of Standard stock solution: Change
0.1 mg/mL of USP Azathioprine RS prepared as follows.
to:
0.5 mg/mL of USP Azathioprine RS prepared as follows.

BANABA LEAF POWDER

DEFINITION

USP38–NF33

5903 01-Jun-2015

USP39–NF34

USP39–NF34

Line 1: Change
dried leaves of Lagerstroemia speciosa (L.) Pers. (Fam. Lythraceae) by extraction with hydroalcoholic mixtures.
to:
dried leaves of Lagerstroemia speciosa (L.) Pers. (Fam. Lythraceae) reduced to powder or very fine powder.

Line 1: Change
dried leaves of Lagerstroemia speciosa (L.) Pers. (Fam. Lythraceae) by extraction with hydroalcoholic mixtures.
to:
dried leaves of Lagerstroemia speciosa (L.) Pers. (Fam. Lythraceae) reduced to powder or very fine powder.

BENZOYL PEROXIDE GEL

IMPURITIES/Organic Impurities

USP38–NF33

2399 01-Jun-2015

USP39–NF34

USP39–NF34

Line 18 of Standard solution D: Change
hydrous benzoyl peroxide (C14H10O4).
to:
anhydrous benzoyl peroxide (C14H10O4).

Line 18 of Standard solution D: Change
hydrous benzoyl peroxide (C14H10O4).
to:
anhydrous benzoyl peroxide (C14H10O4).

CEFAZOLIN FOR INJECTION

ASSAY/Procedure

USP38–NF33

2652 01-Jun-2015

USP39–NF34

USP39–NF34

Line 7 of Analysis: Change
Result = (R

U
/R

S
) × (C

S
/C

U
) × P × F × 100
to:
Result = (R

U
/R

S
) × (C

S
/C

U
) × P × 100
AND
Line 17 of Analysis: Change
P = potency of cefadroxil in USP Cefadroxil RS (µg/mg)
to:
P = potency of cefazolin in USP Cefazolin RS (mg/mg)
AND
Line 19 of Analysis: Delete

F = conversion factor, 0.001 mg/µg

Line 7 of Analysis: Change
Result = (R

U
/R

S
) × (C

S
/C

U
) × P × F × 100
to:
Result = (R

U
/R

S
) × (C

S
/C

U
) × P × 100
AND
Line 17 of Analysis: Change

Read more

CEFIXIME

CHEMICAL INFORMATION

USP38–NF33

2665 01-Jun-2015

USP39–NF34

USP39–NF34

Line 9: Change
[79350-37-1].
to:
[125110-14-7].
Anhydrous

[79350-37-1].

Line 9: Change
[79350-37-1].
to:
[125110-14-7].
Anhydrous

[79350-37-1].

CEFOTAXIME FOR INJECTION

ASSAY/Procedure

USP38–NF33

2678 01-Jun-2015

USP39–NF34

USP39–NF34

Line 10 of the Calculate statement in the Analysis: Change
C

U
= nominal concentration of cefotaxime sodium in Sample solution 1, 2, 3, or 4 (mg/mL)
to:
C

U
= nominal concentration of cefotaxime in Sample solution 1, 2, 3, or 4 (mg/mL)

Line 10 of the Calculate statement in the Analysis: Change
C

U
= nominal concentration of cefotaxime sodium in Sample solution 1, 2, 3, or 4 (mg/mL)
to:
C

U
= nominal concentration of cefotaxime in Sample solution 1, 2, 3, or 4 (mg/mL)

CISATRACURIUM BESYLATE

SPECIFIC TESTS/Water Determination, Method Ia <921>

USP38–NF33

2828 01-Jun-2015

USP39–NF34

USP39–NF34

Line 1: Change
Method Ia

to:
Method Ic

Line 1: Change
Method Ia

to:
Method Ic

CROMOLYN SODIUM OPHTHALMIC SOLUTION

Related compounds

USP38–NF33

2962 01-Jun-2015

USP39–NF34

USP39–NF34

Line 1: Change
It meets the requirements of the test for Related compounds under Cromolyn Sodium Inhalation Solution, “Ophthalmic Solution” being read in place of “Inhalation Solution.”

to:
Apply 10-µL portions of Ophthalmic Solution and Standard solutions of USP Cromolyn Sodium RS in a mixture of water, stabilizer-free tetrahydrofuran, and acetone (6:4:1) containing 10 mg per mL (Standard solution A) and 0.1 mg per mL (Standard solution B) to a suitable thin-layer chromatographic plate (see Chromatography <621>) coated with a 0.25-mm layer of chromatographic silica gel mixture. Allow the spots to dry, and develop the chromatogram in a solvent system consisting of a mixture of chloroform, methanol, and glacial acetic acid (9:9:2) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, mark the solvent front, and allow the solvent to evaporate. Locate the spots on the plate by viewing under short-wavelength UV light: the RF
value of the principal spot obtained from the Ophthalmic Solution corresponds to that obtained from Standard solution A. Any spot in the chromatogram obtained from the Ophthalmic Solution moving ahead of the principal spot is not more intense than the spot in the chromatogram obtained from Standard solution B (1.0%).

Line 1: Change
It meets the requirements of the test for Related compounds under Cromolyn Sodium Inhalation Solution, “Ophthalmic Solution” being read in place of “Inhalation Solution.”

Read more

CROMOLYN SODIUM OPHTHALMIC SOLUTION

Assay

USP38–NF33

2962 01-Jun-2015

USP39–NF34

USP39–NF34

Line 1 of Procedure: Change
Proceed as directed for Procedure in the Assay under Cromolyn Sodium Inhalation Solution.

to:
Concomitantly determine the absorbances of the Standard preparation and the Assay preparation in 1-cm cells at the wavelength of maximum absorbance at about 326 nm, with a suitable spectrophotometer, using a 1 in 100 aqueous solution of pH 7.4 Sodium phosphate buffer as the blank. Calculate the quantity, in mg, of C23H14Na2O11 in each mL of the Ophthalmic Solution taken by the formula:

(C/V)(AU
/AS
)
in which C is the concentration, in µg per mL, of USP Cromolyn Sodium RS in the Standard preparation; V is the volume, in mL, of Ophthalmic Solution taken; and AU
and AS
are the absorbances of the solutions obtained from the Assay preparation and the Standard preparation, respectively.

Line 1 of Procedure: Change
Proceed as directed for Procedure in the Assay under Cromolyn Sodium Inhalation Solution.

Read more

CUPRIC SULFATE

ASSAY/Procedure/Titrimetric system

USP38–NF33

2965 01-Jun-2015

USP39–NF34

USP39–NF34

Line 1 of Endpoint detection: Change
Potentiometric
to:
Visual

Line 1 of Endpoint detection: Change
Potentiometric
to:
Visual

FEXOFENADINE HYDROCHLORIDE TABLETS

PERFORMANCE TESTS/Dissolution <711>/Test 1

USP38–NF33

3487 01-Jun-2015

USP39–NF34

USP39–NF34

Line 4 of System suitability solution: Change
[Note—A small amount of acetic acid,
to:
[Note—A small amount of glacial acetic acid,

Line 4 of System suitability solution: Change
[Note—A small amount of acetic acid,
to:
[Note—A small amount of glacial acetic acid,

IDARUBICIN HYDROCHLORIDE INJECTION

SPECIFIC TESTS/Constituted Solution

USP38–NF33

3834 01-Jun-2015

USP39–NF34

USP39–NF34

Delete the Constituted Solution test.

Delete the Constituted Solution test.

ISONIAZID

IMPURITIES/Organic Impurities

First Supplement to USP38–NF33

7413 01-Jun-2015

USP39–NF34

USP39–NF34

Row 2 of Column 1 of Table 1:
Change
Isoniacin
to
Isoniacina

AND
Row 5 of Column 1 of Table 1: Change
Picolinohydrazide
to
Picolinohydrazideb

AND
Row 6 of Column 1 of Table 1: Change
Isonicotinonitrile
to:
Isonicotinonitrilec

AND

Add footnotes to Table 1:
a Isonicotinic acid.

b 2-Isoniazid.
c 4-Cyanopyridine.

Row 2 of Column 1 of Table 1:
Change
Isoniacin
to
Isoniacina

AND
Row 5 of Column 1 of Table 1: Change
Picolinohydrazide
to
Picolinohydrazideb

AND
Row 6 of Column 1 of Table 1: Change
Isonicotinonitrile
to:
Isonicotinonitrilec

AND

Add footnotes to Table 1:
a Isonicotinic acid.

b 2-Isoniazid.
c 4-Cyanopyridine.

LEVETIRACETAM

IMPURITIES/Organic Impurities

USP38–NF33

4060 01-Jun-2015

USP39–NF34

USP39–NF34

Line 2 of Procedure 2: Change
Buffer, Solution A, Solution B, Mobile phase, System suitability solution, and Chromatographic system:
to:
Buffer, Solution A, Solution B, Mobile phase, System suitability solution, Chromatographic system, and System suitability:

Line 2 of Procedure 2: Change
Buffer, Solution A, Solution B, Mobile phase, System suitability solution, and Chromatographic system:
to:
Buffer, Solution A, Solution B, Mobile phase, System suitability solution, Chromatographic system, and System suitability:

LEVODOPA CAPSULES

IMPURITIES/Organic Impurities

USP38–NF33

4078 01-Jun-2015

USP39–NF34

USP39–NF34

Line 2 of Spray reagent: Change
(10 mg/mL)
to:
(100 mg/mL)

Line 2 of Spray reagent: Change
(10 mg/mL)
to:
(100 mg/mL)

METHYLPHENIDATE HYDROCHLORIDE

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP38–NF33

4345 01-Jun-2015

USP39–NF34

USP39–NF34

Line 3 of USP Methylphenidate Related Compound A RS: Change
255.75
to:
255.74

Line 3 of USP Methylphenidate Related Compound A RS: Change
255.75
to:
255.74

METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP38–NF33

4348 01-Jun-2015

USP39–NF34

USP39–NF34

Line 3 of USP Methylphenidate Related Compound A RS: Change
255.75
to:
255.74

Line 3 of USP Methylphenidate Related Compound A RS: Change
255.75
to:
255.74

METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS

PERFORMANCE TESTS/Dissolution <711>/Test 2

USP38–NF33

4348 01-Jun-2015

USP39–NF34

USP39–NF34

Line 3 of Apparatus 7: Change
coil sample holder (Figure 4d).

to:
spring sample holder (Figure 5d).

Line 3 of Apparatus 7: Change
coil sample holder (Figure 4d).

to:
spring sample holder (Figure 5d).

NIACIN

IMPURITIES/Related Compounds

First Supplement to USP38–NF33

7447 01-Jun-2015

USP39–NF34

USP39–NF34

Row 14 of Column 1 of Table 2: Change
Total impurities
to:
Total specified impurities

Row 14 of Column 1 of Table 2: Change
Total impurities
to:
Total specified impurities

ORAL REHYDRATION SALTS

ASSAY/Dextrose

USP38–NF33

5145 01-Jun-2015

USP39–NF34

USP39–NF34

Line 10 of Analysis: Change
A = 100 mm divided by the length of the polarimeter tube (mm)
to:
A =
100 divided by the length of the polarimeter tube (dm)
AND
Line 21 of Analysis: Change
A = 100 mm divided by the length of the polarimeter tube (mm)
to:
A =
100 divided by the length of the polarimeter tube (dm)

Line 10 of Analysis: Change
A = 100 mm divided by the length of the polarimeter tube (mm)
to:
A =
100 divided by the length of the polarimeter tube (dm)
AND
Line 21 of Analysis: Change
A = 100 mm divided by the length of the polarimeter tube (mm)
to:
A =
100 divided by the length of the polarimeter tube (dm)

PROTAMINE SULFATE

SPECIFIC TESTS/pH <791>

USP38–NF33

5069 01-Jun-2015

USP39–NF34

USP39–NF34

Delete the test for pH

Delete the test for pH

QUININE SULFATE

CHEMICAL INFORMATION

USP38–NF33

5122 01-Jun-2015

USP39–NF34

USP39–NF34

Line 4: Change
dihydrate [6119-70-6].
to:
dihydrate [207671-44-1].

Line 4: Change
dihydrate [6119-70-6].
to:
dihydrate [207671-44-1].

REAGENTS

REAGENT SPECIFICATIONS/Ferric Sulfate

USP38–NF33

1841 01-Jun-2015

USP39–NF34

USP39–NF34

Line 1: Change
[10028-22-5]
to:
[15244-10-7]

Line 1: Change
[10028-22-5]
to:
[15244-10-7]

SODIUM CETOSTEARYL SULFATE

IMPURITIES/Limit of Free Cetostearyl Alcohol

USP38–NF33

6868 01-Jun-2015

USP39–NF34

USP39–NF34

Line 5 of Analysis: Change
Result = 100(rA
+ rB
) × WIS
× (SA(corr)
× W)
to:
Result = 100(rA
+ rB
) × WIS
/(SA(corr)
× W)
AND
Line 12 of Analysis: Change

SA(corr)


to:
SA(corr)

Line 5 of Analysis: Change
Result = 100(rA
+ rB
) × WIS
× (SA(corr)
× W)
to:
Result = 100(rA
+ rB
) × WIS
/(SA(corr)
× W)
AND
Line 12 of Analysis: Change

SA(corr)

to:
SA(corr)

SODIUM CHLORIDE

IMPURITIES/Limit of Phosphates

Harmonization (Official December 01, 2015)

ONLINE 01-Jun-2015

USP39–NF34

USP39–NF34

Line 2 of Analysis: Change
add 4 mL of sulfomolybdic acid TS,
to:
add 4 mL of Sulfomolybdic acid solution,

Line 2 of Analysis: Change
add 4 mL of sulfomolybdic acid TS,
to:
add 4 mL of Sulfomolybdic acid solution,

TELMISARTAN TABLETS

ASSAY/Procedure

Revision Bulletin (Official December 01, 2014)

ONLINE 01-Jun-2015

USP39–NF34

USP39–NF34

Line 2 of Standard solution: Change
of USP Telmisartan Related Compound A RS in Mobile phase.
to:
of USP Telmisartan Related Compound A RS in Mobile phase from the Standard stock solution.

Line 2 of Standard solution: Change
of USP Telmisartan Related Compound A RS in Mobile phase.
to:
of USP Telmisartan Related Compound A RS in Mobile phase from the Standard stock solution.

XLS CSV