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
<1788> METHODS FOR THE DETERMINATION OF PARTICULATE MATTER IN INJECTIONS AND OPHTHALMIC SOLUTIONS LIGHT OBSCURATION PARTICLE COUNT TEST/Instrument Standardization Tests/Particle Counting Accuracy—System Suitability USP37–NF32 1301 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Line 26 of Method 1—MWHC Instruments: Change
PB is the average particle count obtained from the suspension;
to:
PS is the average particle count obtained from the suspension;


Line 26 of Method 1—MWHC Instruments: Change
PB
is the average particle count obtained from the suspension;
to:
PS
is the average particle count obtained from the suspension;

<551> VITAMIN E ASSAY ASSAY/Procedure 4/Chromatographic system First Supplement to USP37–NF32 6338 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Line 1 of Flow rate: Change
1.5 mL/min
to:
1 mL/min


Line 1 of Flow rate: Change
1.5 mL/min
to:
1 mL/min

<795> PHARMACEUTICAL COMPOUNDING—NONSTERILE PREPARATIONS DEFINITIONS USP37–NF32 403 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Line 1 of Beyond-Use Date (BUD): Change
The date after which a compounded preparation should not to be used;
to:
The date after which a compounded preparation shall not be used;


Line 1 of Beyond-Use Date (BUD): Change
The date after which a compounded preparation should not to be used;
to:
The date after which a compounded preparation shall not be used;

ALLOPURINOL USP Reference standards <11> USP37–NF32 1649 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Line 2 of USP Allopurinol Related Compound C RS: Change
N-(4H-1,2,4-Triazol-4-yl)-1H-pyrazole-4-carboxamide.
to:
5-(4H-1,2,4-Triazol-4-yl)-1H-pyrazole-4-carboxamide.


Line 2 of USP Allopurinol Related Compound C RS: Change
N-(4H-1,2,4-Triazol-4-yl)-1H-pyrazole-4-carboxamide.
to:
5-(4H-1,2,4-Triazol-4-yl)-1H-pyrazole-4-carboxamide.

AMIFOSTINE ASSAY/Procedure/System suitability/Suitability requirements USP37–NF32 1717 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Line 1 of Column efficiency: Change
NLT 100
to:
NLT 1000


Line 1 of Column efficiency: Change
NLT 100
to:
NLT 1000

ATROPINE SULFATE ASSAY/Procedure/System suitability/Suitability requirements First Supplement to USP37–NF32 6591 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Line 1 of Relative standard deviation: Change
NMT 1.0
to:
NMT 1.0%


Line 1
of Relative standard deviation: Change
NMT 1.0
to:
NMT 1.0%

BUMETANIDE IMPURITIES USP37–NF32 2024 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Row 4 of Column 1 of Table 1: Change
Paroxetine butyl 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoate
to:
Butyl 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoate


Row 4 of Column 1 of Table 1: Change
Paroxetine butyl 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoate
to:
Butyl 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoate

CEFADROXIL ASSAY/Procedure First Supplement to USP37–NF32 6602 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Line 3 of Sample solution: Change
USP Cefadroxil RS
to:
Cefadroxil


Line 3 of Sample solution: Change
USP Cefadroxil RS
to:
Cefadroxil

CEFADROXIL CAPSULES ADDITIONAL REQUIREMENTS/USP Reference Standards <11> First Supplement to USP37–NF32 6604 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Line 2 of USP Cefadroxil Related Compound I RS: Change
(6R,7R)-7-[(R)-2-Amino-2-(4-hydroxyphenyl)acetamido]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate.
to:
(6R,7R)-7-[(R)-2-Amino-2-(4-hydroxyphenyl)acetamido]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-3-ene-2-carboxylic acid.


Line 2 of USP Cefadroxil Related Compound I RS: Change
(6R,7R)-7-[(R)-2-Amino-2-(4-hydroxyphenyl)acetamido]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate.
to:
(6R,7R)-7-[(R)-2-Amino-2-(4-hydroxyphenyl)acetamido]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-3-ene-2-carboxylic acid.

CEFAZOLIN INJECTION Assay USP37–NF32 2190 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Change
pH 3.6 Buffer, pH 7.0 Buffer, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Cefazolin.
to:
pH 3.6 Buffer—Dissolve 0.900 g of anhydrous dibasic sodium phosphate and 1.298 g of citric acid monohydrate in water to make 1000 mL.
pH 7.0 Buffer—Dissolve 5.68 g of anhydrous dibasic sodium phosphate and 3.63 g of monobasic potassium phosphate in water to make 1000 mL.
Mobile phase—Prepare a suitable mixture of pH 3.6 Buffer and acetonitrile (9:1). Pass through a membrane filter having a 10-μm or finer porosity, and degas. Make adjustments if necessary (see System Suitability under Chromatography <621>).
Internal standard solution—Transfer 750 mg of salicylic acid to a 100-mL volumetric flask, dissolve in 10 mL of methanol, dilute with pH 7.0 Buffer to volume, and mix.
Standard preparation—Transfer about 25 mg of USP Cefazolin RS, accurately weighed, to a 25-mL volumetric flask, dissolve in and dilute with pH 7.0 Buffer to volume, and mix. Transfer 5.0 mL of this solution to a 100-mL volumetric flask, add 5.0 mL of Internal standard solution, dilute with pH 7.0 Buffer to volume, and mix.
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 254-nm detector and a 4.0-mm × 30-cm column that contains 10-μm packing L1. The flow rate is about 2 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure. The relative retention times are about 0.7 for salicylic acid and 1.0 for cefazolin; the resolution, R, between the analyte and internal standard peaks is not less than 4.0; the column efficiency is not less than 1500 theoretical plates; the tailing factor is not more than 1.5; and the relative standard deviation for replicate injections is not more than 2.0%.
AND
Change
Procedure—Proceed as directed for Procedure in the Assay under Cefazolin. Calculate the quantity, in mg, of cefazolin (C14H14N8O4S3) in each mL of the Injection taken by the formula:
(1000C / V)(RU / RS )
in which V is the volume, in mL, of Injection taken, and the other terms are as defined therein.
to:
Procedure—Separately inject equal volumes (about 10 μL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of cefazolin (C14H14N8O4S3) in each mL of Injection taken by the formula:
(1000C / V)(RU / RS )
in which C is the concentration, in mg per mL, of USP Cefazolin RS, calculated on the anhydrous basis, in the Standard preparation; V is the volume, in mL, of Injection taken; and RU and RS are the peak response ratios of cefazolin to the internal standard obtained from the Assay preparation and the Standard preparation, respectively.
















Change
pH 3.6 Buffer, pH 7.0 Buffer, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Cefazolin.

Read more
CEFTIZOXIME FOR INJECTION Constituted solution USP37–NF32 2240 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Line 1: Change
At the time of use, it meets the requirements for Constituted Solutions under Labeling under Injections <1>.
to:
At the time of use, it meets the requirements for Constituted Solutions under Injections <1>.


Line 1: Change
At the time of use, it meets the requirements for Constituted Solutions under Labeling under Injections <1>.
to:
At the time of use, it meets the requirements for Constituted Solutions under Injections <1>.

CEFTRIAXONE INJECTION Assay USP37–NF32 2241 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Change
pH 7.0 Buffer, pH 5.0 Buffer, Mobile phase, Standard preparation, Resolution solution, and Chromatographic system—Prepare as directed in the Assay under Ceftriaxone Sodium.
to:
pH 7.0 Buffer—Dissolve 13.6 g of dibasic potassium phosphate and 4.0 g of monobasic potassium phosphate in water to obtain 1000 mL of solution. Adjust this solution with phosphoric acid or 10 N potassium hydroxide to a pH of 7.0 ± 0.1.
pH 5.0 Buffer—Dissolve 25.8 g of sodium citrate in 500 mL of water, adjust with citric acid solution (1 in 5) to a pH of 5.0 ± 0.1, and dilute with water to a volume of 1000 mL.
Mobile phase—Dissolve 3.2 g of tetraheptylammonium bromide in 400 mL of acetonitrile, add 44 mL of pH 7.0 Buffer and 4 mL of pH 5.0 Buffer, and add water to make 1000 mL. Pass through a membrane filter of 0.5-μm or finer porosity, and degas. Make adjustments if necessary (see System Suitability under Chromatography <621>).
Standard preparation—Dissolve an accurately weighed quantity of USP Ceftriaxone Sodium RS in Mobile phase to obtain a solution having a known concentration of about 0.2 mg per mL. Use this solution promptly after preparation.
Resolution solution—Dissolve a suitable quantity of USP Ceftriaxone Sodium E-Isomer RS in Standard preparation, and dilute with Mobile phase to obtain a solution containing about 160 µg of USP Ceftriaxone Sodium E-Isomer RS per mL and 160 µg of USP Ceftriaxone Sodium RS per mL. Use this solution promptly after preparation.
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 270-nm detector and a 4.0-mm × 15-cm column that contains 5-μm packing L1. The flow rate is about 2 mL per minute. Chromatograph the Resolution solution, and record the peak responses as directed for Procedure. The resolution, R, between the ceftriaxone E-isomer and ceftriaxone peaks is not less than 3. Chromatograph the Standard preparation, and record the peak responses as directed under Procedure. The column efficiency determined from the analyte peak is not less than 1500 theoretical plates, the tailing factor for the analyte is not more than 2, and the relative standard deviation for replicate injections is not more than 2%.
AND
Change
Procedure—Proceed as directed for Procedure in the Assay under Ceftriaxone Sodium. Calculate the quantity, in mg, of ceftriaxone (C18H18N8O7S3) in each mL of the Injection taken by the formula:
200(C / V)(rU / rS )
in which V is the volume, in mL, of Injection taken; and the other terms are as defined therein.
to:
Procedure—Separately inject equal volumes (about 20 μL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of ceftriaxone (C18H18N8O7S3) in each mL of Injection taken by the formula:
200(C / V)(rU / rS )
in which C is the concentration, in mg per mL, of USP Ceftriaxone Sodium RS in the Standard preparation; V is the volume, in mL, of Injection taken; and rU and rS are the ceftriaxone peak responses obtained from the Assay preparation and the Standard preparation, respectively.
















Change
pH 7.0 Buffer, pH 5.0 Buffer, Mobile phase, Standard preparation, Resolution solution, and Chromatographic system—Prepare as directed in the Assay under Ceftriaxone Sodium.

to:
pH 7.0 Buffer—Dissolve 13.6 g of dibasic potassium phosphate and 4.0 g of monobasic potassium phosphate in water to obtain 1000 mL of solution.

Read more
CEFUROXIME FOR INJECTION Constituted solution USP37–NF32 2246 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Line 3: Change
meets the requirements for Constituted Solutions under Labeling under Injections <1>.
to:
meets the requirements for Constituted Solutions under Injections <1>.


Line 3: Change
meets the requirements for Constituted Solutions under Labeling under Injections <1>.
to:
meets the requirements for Constituted Solutions under Injections <1>.

CHLORDIAZEPOXIDE HYDROCHLORIDE FOR INJECTION Constituted solution USP37–NF32 2290 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Line 1: Change
At the time of use, it meets the requirements for Constituted Solutions under Labeling under Injections <1>.
to:
At the time of use, it meets the requirements for Constituted Solutions under Injections <1>.


Line 1: Change
At the time of use, it meets the requirements for Constituted Solutions under Labeling under Injections <1>.
to:
At the time of use, it meets the requirements for Constituted Solutions under Injections <1>.

CLOPIDOGREL BISULFATE ASSAY/Procedure USP37–NF32 2422 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Line 1 of System suitability solution: Change
25 µg/mL of USP Clopidogrel Bisulfate RS and 50 µg/mL of USP Clopidogrel Related Compound B RS
to:
2.5 µg/mL of USP Clopidogrel Bisulfate RS and 5.0 µg/mL of USP Clopidogrel Related Compound B RS


Line 1 of System suitability solution: Change
25 µg/mL of USP Clopidogrel Bisulfate RS and 50 µg/mL of USP Clopidogrel Related Compound B RS
to:
2.5 µg/mL of USP Clopidogrel Bisulfate RS and 5.0 µg/mL of USP Clopidogrel Related Compound B RS

DOXAPRAM HYDROCHLORIDE INJECTION ASSAY/Procedure USP37–NF32 2708 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Line 7 of Analysis: Change
RU = peak response ratio of the doxapram to the internal standard from the Sample solution
RS = peak response ratio of the doxapram to the internal standard from the Sample solution
to:
RU = peak response ratio of doxapram to the internal standard from the Sample solution
RS = peak response ratio of doxapram to the internal standard from the Standard solution




Line 7 of Analysis: Change
RU
= peak response ratio of the doxapram to the internal standard from the Sample solution

RS
=
peak response ratio of the doxapram to the internal standard from the Sample solution

to:
RU
=

peak response ratio of doxapram to the internal standard from the Sample solution

RS
=

peak response ratio of doxapram to the internal standard from the Standard solution

DOXEPIN HYDROCHLORIDE CAPSULES PERFORMANCE TESTS USP37–NF32 2712 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Change
Uniformity of Dosage Units, Content Uniformity <905>
to:
Uniformity of Dosage Units <905>: Meet the requirements
The following procedure is used where the test for Content Uniformity is required.
Procedure for Content Uniformity
AND
Delete a subsection:
Acceptance criteria: Meet the requirements







Change
Uniformity of Dosage Units, Content Uniformity <905>

to:
Uniformity of Dosage Units <905>: Meet the requirements
The following procedure is used where the test for Content Uniformity is required.
Procedure for Content Uniformity

AND
Delete a subsection:
Acceptance criteria: Meet the requirements

DULOXETINE DELAYED-RELEASE CAPSULES IDENTIFICATION USP37–NF32 2743 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Change
A. Infrared Absorption <197S>
to:
A. Infrared Absorption <197F>


Change
A. Infrared Absorption <197S>

to:
A. Infrared Absorption <197F>

ERGOTAMINE TARTRATE Identification USP37–NF32 2826 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Line 4: Change
value as the principal spot of Standard solution A.
to:
values as the corresponding spots of the Standard preparation.


Line 4:
Change
value as the principal spot of Standard solution A.
to:
values as the corresponding spots of the Standard preparation.

FLAVOXATE HYDROCHLORIDE IMPURITIES USP37–NF32 2988 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Row 3 of Column 1 of Impurity Table 1: Change
Flavoxate related compound Aa,*
to:
Flavoxate related compound Aa
AND
Row 4 of Column 1 of Impurity Table 1: Change
Flavoxate related compound Bb,*
to:
Flavoxate related compound Bb
AND
Row 5 of Column 1 of Impurity Table 1: Change
Flavoxate related compound Cc,*
to:
Flavoxate related compound Cc
AND
Delete footnote *
















Row 3 of Column 1 of Impurity Table 1: Change

Flavoxate related compound Aa,*
to:
Flavoxate related compound Aa

AND
Row 4 of Column 1 of Impurity Table 1: Change

Flavoxate related compound Bb,*
to:
Flavoxate related compound Bb

AND
Row 5 of Column 1 of Impurity Table 1: Change

Flavoxate related compound Cc,*
to:
Flavoxate related compound Cc

AND
Delete footnote *

Read more
GELATIN SPECIFIC TESTS/Sulfur Dioxide/Analysis USP37–NF32 5995 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Line 5 of the variable definition list: Change
m = actual molarity of the Titrant (mol/mL)
to:
m = actual molarity of the Titrant (mol/L)


Line 5 of the variable definition list: Change
m = actual molarity of the Titrant (mol/mL)
to:
m = actual molarity of the Titrant (mol/L)

GENERAL NOTICES TO USP-NF 6. TESTING PRACTICES AND PROCEDURES/6.50. Preparation of Solutions First Supplement to USP37–NF32 6291 01-Aug-2014 USP38–NF33 USP38–NF33
Line 6 of 6.50.20. Solutions: Change
An expression such as “(1 in 10)” means that 1 part by volume of a liquid shall be diluted with a sufficient quantity of the diluent or solvent to make the volume of the finished solution 10 parts by volume. An expression such as “(20:5:2)” means that the respective numbers of parts, by volume, of the designated liquids shall be mixed, unless otherwise indicated.
to:
An expression such as “(1 in 10)” means that 1 part by volume of a liquid shall be diluted with, or 1 part by weight of a solid shall be dissolved in, a sufficient quantity of the diluent or solvent to make the volume of the finished solution 10 parts by volume. An expression such as “(20:5:2)” means that the respective numbers of parts, by volume, of the designated liquids shall be mixed, unless otherwise indicated.


Line 6 of 6.50.20. Solutions: Change
An expression such as “(1 in 10)” means that 1 part by volume of a liquid shall be diluted with a sufficient quantity of the diluent or solvent to make the volume of the finished solution 10 parts by volume. An expression such as “(20:5:2)” means that the respective numbers of parts, by volume, of the designated liquids shall be mixed, unless otherwise indicated.

Read more
INSULIN ASPART IDENTIFICATION/B. Physicochemical Analytical Procedures for Insulins, Peptide Mapping <121.1>/Chromatographic system First Supplement to USP37–NF32 6647 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Line 1 of Column: Change
4.0-mm × 25-cm; 5-µm packing L7
to:
4.6-mm × 10-cm; 3-μm packing L1


Line 1 of Column: Change
4.0-mm × 25-cm; 5-µm packing L7
to:
4.6-mm × 10-cm; 3-μm packing L1

LEFLUNOMIDE IMPURITIES/Organic Impurities/Procedure 2 USP37–NF32 3502 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Line 3 of Analysis: Change
[Note—Disregard any peak with an area less than the leflunomide peak from the System suitability solution.
to:
[Note—Disregard any peak with an area less than the leflunomide peak from the Sensitivity solution.


Line 3 of Analysis: Change
[Note—Disregard any peak with an area less than the leflunomide peak from the System suitability solution.
to:
[Note—Disregard any peak with an area less than the leflunomide peak from the Sensitivity solution.

LEVALBUTEROL HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP37–NF32 3513 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Line 2 of USP Levalbuterol Related Compound H RS: Change
4-[2-(tert-Butylamino)-1-methoxyethyl]-2-(hydroxymethyl)phenol.
C14H23NO3 253.34
to:
4-[2-(tert-Butylamino)-1-methoxyethyl]-2-(hydroxymethyl)phenol acetate.
C14H23NO3 · C2H4O2 313.39




Line 2 of USP Levalbuterol Related Compound H RS: Change
4-[2-(tert-Butylamino)-1-methoxyethyl]-2-(hydroxymethyl)phenol.
C14H23NO3 253.34
to:
4-[2-(tert-Butylamino)-1-methoxyethyl]-2-(hydroxymethyl)phenol acetate.

C14H23NO3 · C2H4O2 313.39

LEVODOPA IMPURITIES USP37–NF32 3533 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Row 6 of Column 1 of Table 1: Change
1-Veratrylglycine
to:
L-Veratrylglycinea
AND
Add a footnote:
a3-(3,4-Dimethoxyphenyl)-L-alanine.





Row 6 of Column 1 of Table 1: Change
1-Veratrylglycine
to:
L-Veratrylglycinea

AND
Add a footnote:
a3-(3,4-Dimethoxyphenyl)-L-alanine.

LEVOTHYROXINE SODIUM TABLETS IMPURITIES/Organic Impurities/Procedure: Limit of Liothyronine Sodium USP37–NF32 3548 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Line 1 of Acceptance criteria: Change
NMT 2.0% of liothyronine
to:
NMT 2.0% of liothyronine sodium


Line 1 of Acceptance criteria: Change
NMT 2.0% of liothyronine

to:
NMT 2.0% of liothyronine sodium

MITOTANE TABLETS Assay USP37–NF32 3858 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Line 1 of Procedure: Change
Proceed as directed in the Assay under Mitotane, beginning with “Concomitantly determine the absorbances of both solutions.”
to:
Concomitantly determine the absorbances of the Assay preparation and the Standard preparation in 1-cm cells at the wavelength of maximum absorbance at about 268 nm, with a suitable spectrophotometer, using methanol as the blank.
Calculate the quantity, in mg, of C14H10Cl4 in the portion of Tablets taken by the formula:
0.5C(A U /A S )
in which C is the concentration, in mg/mL, of USP Mitotane RS in the Standard preparation, and A U and A S are the absorbances of the Assay preparation and the Standard preparation, respectively.





Line 1 of Procedure: Change
Proceed as directed in the Assay under Mitotane, beginning with “Concomitantly determine the absorbances of both solutions.”
to:
Concomitantly determine the absorbances of the Assay preparation and the Standard preparation in 1-cm cells at the wavelength of maximum absorbance at about 268 nm, with a suitable spectrophotometer, using methanol as the blank.
Calculate the quantity, in mg, of C14H10Cl4 in the portion of Tablets taken by the formula:
0.5C(A

U

Read more
NALTREXONE HYDROCHLORIDE Assay USP37–NF32 3922 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Line 7 of Procedure: Change
(377.86/341.41)10C(r U /r S )
in which 377.86 and 341.41 are the molecular weights of naltrexone hydrochloride and naltrexone
to:
(377.86/341.40)10C(r U /r S )
in which 377.86 and 341.40 are the molecular weights of naltrexone hydrochloride and naltrexone




Line 7 of Procedure: Change
(377.86/341.41)10C(r

U
/r

S
)
in which 377.86 and 341.41 are the molecular weights of naltrexone hydrochloride and naltrexone
to:
(377.86/341.40)10C(r

U
/r

S
)
in which 377.86 and 341.40 are the molecular weights of naltrexone hydrochloride and naltrexone

RISPERIDONE ORAL SOLUTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP37–NF32 ONLINE 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Line 2 of USP Risperidone Related Compounds Mixture RS: Change
Contains a mixture of the following four compounds:
98.9% of Risperidone.
0.5% of Risperidone cis-N-oxide: cis-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-N-oxide.
0.3% of Bicyclorisperidone: 3-(4-Fluoro-2-hydroxyphenyl)-1-[2-(6,7,8,9-tetrahydro-2-methyl-4-oxo-4H-pyrido-[1,2-a]pyrimidin-3-yl)ethyl]-1-aza-2-azoniabicyclo[2.2.2]oct-2-ene iodide.
0.3% of Z-Oxime: (Z)-3-[2-[4-(2,4-Difluorophenyl)(hydroxyimino)methyl]-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one.
to:
Contains a mixture of the following four compounds:
Risperidone.
Risperidone cis-N-oxide: cis-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one, N-oxide.
Bicyclorisperidone: 3-(4-Fluoro-2-hydroxyphenyl)-1-[2-(6,7,8,9-tetrahydro-2-methyl-4-oxo-4H-pyrido-[1,2-a]pyrimidin-3-yl)ethyl]-2-aza-1-azoniabicyclo[2.2.2]oct-2-ene iodide.
Z-Oxime: (Z)-3-[2-[4-(2,4-Difluorophenyl)(hydroxyimino)methyl]-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one.










Line 2 of USP Risperidone Related Compounds Mixture RS: Change

Contains a mixture of the following four compounds:
98.9% of Risperidone.
0.5% of Risperidone cis-N-oxide: cis-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-N-oxide.
0.3% of Bicyclorisperidone: 3-(4-Fluoro-2-hydroxyphenyl)-1-[2-(6,7,8,9-tetrahydro-2-methyl-4-oxo-4H-pyrido-[1,2-a]pyrimidin-3-yl)ethyl]-1-aza-2-azoniabicyclo[2.2.2]oct-2-ene iodide.
0.3% of Z-Oxime: (Z

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ROPINIROLE HYDROCHLORIDE IMPURITIES/Organic Impurities, Procedure 1/System suitability/Suitability requirements Revision Bulletin (Official May 01, 2014) ONLINE 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Line 1 of Tailing factor: Change
NLT 2.0 for the ropinirole peak
to:
NMT 2.0 for the ropinirole peak


Line 1 of Tailing factor: Change
NLT 2.0 for the ropinirole peak
to:
NMT 2.0 for the ropinirole peak

SUFENTANIL CITRATE ASSAY/Procedure/System suitability/Suitability requirements First Supplement to USP37–NF32 6701 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Line 1 of Relative standard deviation: Change
NMT 0.7%
to:
NMT 0.73%


Line 1 of Relative standard deviation: Change
NMT 0.7%
to:
NMT 0.73%

TERBINAFINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> First Supplement to USP37–NF32 6704 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Line 2 of USP Terbinafine Related Compound A RS: Change
N-Methyl-C-(naphthalen-1-yl)methanamine.
to:
N-Methyl-C-(naphthalen-1-yl)methanamine hydrochloride.
AND
Line 2 of USP Terbinafine Related Compound B RS: Change
(2Z)-N,6,6-Trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine.
to:
(2Z)-N,6,6-Trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine hydrochloride.
AND
Line 2 of USP Terbinafine Related Compound C: Change
(2E)-N,6,6-Trimethyl-N-(naphthalen-2-ylmethyl)hept-2-en-4-yn-1-amine.
to:
(2E)-N,6,6-Trimethyl-N-(naphthalen-2-ylmethyl)hept-2-en-4-yn-1-amine hydrochloride.
AND
Line 2 of Terbinafine Related Compound D RS: Change
(2E)-N,6,6-Trimethyl-N-[(4-methylnaphthalen-1-yl)methyl]hept-2-en-4-yn-1-amine.
to:
(2E)-N,6,6-Trimethyl-N-[(4-methylnaphthalen-1-yl)methyl]hept-2-en-4-yn-1-amine hydrochloride.

















Line 2 of USP Terbinafine Related Compound A RS: Change
N-Methyl-C-(naphthalen-1-yl)methanamine.

to:
N-Methyl-C-(naphthalen-1-yl)methanamine hydrochloride.
AND
Line 2 of USP Terbinafine Related Compound B RS: Change
(2Z)-N,6,6-Trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine.
to:

(2Z)-N,6,6-Trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine hydrochloride.
AND
Line 2 of USP Terbinafine Related Compound C: Change
(2E)-N,6,6-Trimethyl-N-(nap

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TERBINAFINE HYDROCHLORIDE IMPURITIES First Supplement to USP37–NF32 6704 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Footnotes b, c, and d of Table 2: Change
b trans-Isoterbinafine or (E)-N,6,6-trimethyl-N-(naphthalen-2-ylmethyl)hept-2-en-4-yn-1-amine.
c cis-Terbinafine or (Z)-N,6,6-trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine.
d4-Methylterbinafine or (E)-N,6,6-trimethyl-N-((4-methylnaphthalen-1-yl)methyl)hept-2-en-4-yn-1-amine.
to:
b trans-Isoterbinafine or (2E)-N,6,6-Trimethyl-N-(naphthalen-2-ylmethyl)hept-2-en-4-yn-1-amine.
c cis-Terbinafine or (2Z)-N,6,6-Trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine.
d4-Methylterbinafine or (2E)-N,6,6-Trimethyl-N-((4-methylnaphthalen-1-yl)methyl)hept-2-en-4-yn-1-amine.






Footnotes b, c, and d of Table 2: Change
b
trans-Isoterbinafine or (E)-N,6,6-trimethyl-N-(naphthalen-2-ylmethyl)hept-2-en-4-yn-1-amine.
c
cis-Terbinafine or (Z)-N,6,6-trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine.
d4-Methylterbinafine or (E)-N,6,6-trimethyl-N-((4-methylnaphthalen-1-yl)methyl)hept-2-en-4-yn-1-amine.
to:
b
trans-Isoterbinafine or (2E)-N,6,6-Trimethyl-N-(naphthalen-2-ylmethyl)hept-2-en-4-yn-

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TICLOPIDINE HYDROCHLORIDE IMPURITIES USP37–NF32 4958 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Change
Residue on Ignition <231>
to:
Residue on Ignition <281>


Change
Residue on Ignition
<231>


to:
Residue on Ignition <281>

TIZANIDINE TABLETS ASSAY/Procedure/System suitability Second Supplement to USP37–NF32 ONLINE 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Change
Sample: Standard solution
to:
Samples: System suitability solution and Standard solution
AND
Change
Resolution: NLT 4.0 between tizanidine and tizanidine related compound C; NLT 4.0 between tizanidine and tizanidine related compound B
Tailing factor: NMT 2.0
Relative standard deviation: NMT 2.0%
to:
Resolution: NLT 4.0 between tizanidine and tizanidine related compound C; NLT 4.0 between tizanidine and tizanidine related compound B, System suitability solution
Tailing factor: NMT 2.0, Standard solution
Relative standard deviation: NMT 2.0%, Standard solution











Change
Sample: Standard solution

to:
Samples: System suitability solution and Standard solution

AND
Change
Resolution: NLT 4.0 between tizanidine and tizanidine related compound C; NLT 4.0 between tizanidine and tizanidine related compound B
Tailing factor: NMT 2.0
Relative standard deviation: NMT 2.0%
to:
Resolution: NLT 4.0 between tizanidine and tizanidine related compound C; NLT 4.0 between tizanidine and tizanidine related compound B, System suitability solution

T

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VINBLASTINE SULFATE IDENTIFICATION/B. USP37–NF32 5150 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Line 1 of Sample: Change
100 mg/mL in water
to:
10 mg/mL in water


Line 1 of Sample: Change
100 mg/mL in water
to:
10 mg/mL in water

VITAMIN E IDENTIFICATION/A./Sample solutions USP37–NF32 5163 01-Aug-2014 USP39–NF34 First Supplement to USP38–NF33
Lines 4 and 7 of Alpha tocopheryl acetate: Change
dilute sulfuric acid
to:
diluted sulfuric acid


Lines 4 and 7 of Alpha tocopheryl acetate: Change
dilute sulfuric acid
to:
diluted sulfuric acid

ACETAMINOPHEN SUPPOSITORIES ASSAY/Procedure USP37–NF32 1567 01-Jun-2014 USP38–NF33 USP38–NF33
Line 6 of Sample stock solution: Change
add 30 mL of hexane,
to:
add 30 mL of solvent hexane,
AND
Line 10 of Sample stock solution: Change
wash the hexane
to:
wash the solvent hexane

Line 6 of Sample stock solution: Change
add 30 mL of hexane,
to:
add 30 mL of solvent hexane,
AND
Line 10 of Sample stock solution: Change
wash the hexane
to:
wash the solvent hexane

ALCOHOL IN DEXTROSE INJECTION ASSAY/Dextrose USP37–NF32 1637 01-Jun-2014 USP38–NF33 USP38–NF33
Line 15 of Analysis: Change
A = length of the polarimeter tube (mm)
to:
A = 100 mm divided by the length of the polarimeter tube (mm)

Line 15 of Analysis: Change
A =
length of the polarimeter tube (mm)

to:
A = 100 mm divided by the length of the polarimeter tube (mm)

ALUMINA, MAGNESIA, CALCIUM CARBONATE, AND SIMETHICONE CHEWABLE TABLETS ASSAY/Magnesium Hydroxide USP37–NF32 1674 01-Jun-2014 USP38–NF33 USP38–NF33
Line 5 of Magnesium stock solution: Change
Transfer 2.0 mL of this solution to a 100-mL volumetric flask to obtain a solution containing 20 μg/mL of magnesium (Mg)
to:
Transfer 1.0 mL of this solution to a 100-mL volumetric flask to obtain a solution containing 10 μg/mL of magnesium (Mg)

Line 5 of Magnesium stock solution: Change
Transfer 2.0 mL of this solution to a 100-mL volumetric flask to obtain a solution containing 20 μg/mL of magnesium (Mg)

to:
Transfer 1.0 mL of this solution to a 100-mL volumetric flask to obtain a solution containing 10 μg/mL of magnesium (Mg)

ALUMINUM CHLOROHYDRATE SOLUTION ASSAY/Procedure 4 USP37–NF32 1686 01-Jun-2014 USP38–NF33 USP38–NF33
Line 2 of Analysis: Change
anhydrous aluminum dichlorohydrate
to:
anhydrous aluminum chlorohydrate

Line 2 of Analysis: Change
anhydrous aluminum dichlorohydrate
to:
anhydrous aluminum chlorohydrate

AMINOSALICYLATE SODIUM ASSAY/Procedure USP37–NF32 1745 01-Jun-2014 USP38–NF33 USP38–NF33
Line 15 of Analysis: Change
CU = concentration of aminosalicylate in the Sample solution (mg/mL)
to:
CU = concentration of Aminosalicylate Sodium in the Sample solution (mg/mL)

Line 15 of Analysis: Change
CU = concentration of aminosalicylate in the Sample solution (mg/mL)

to:
CU = concentration of Aminosalicylate Sodium in the Sample solution (mg/mL)

AMIODARONE HYDROCHLORIDE IMPURITIES/Organic Impurities/Procedure 1 USP37–NF32 1750 01-Jun-2014 USP38–NF33 USP38–NF33
Line 3 of Acceptance criteria: Change
Standard solution B is not more intense
to:
the Sample solution is not more intense

Line 3 of Acceptance criteria: Change
Standard solution B is not more intense
to:
the Sample solution is not more intense

ATROPINE SULFATE IMPURITIES First Supplement to USP37–NF32 6591 01-Jun-2014 USP38–NF33 USP38–NF33
Row 6 of Column 1 of Table 2: Change
Hyoscyamine related compound Ae
to:
Hyoscyamine related compound A
AND
Delete footnote e
AND
Reletter the following footnotes in both the table and footnote definitions:
f to e
g to f

Row 6 of Column 1 of Table 2: Change
Hyoscyamine related compound Ae
to:
Hyoscyamine related compound A
AND
Delete footnote e
AND
Reletter the following footnotes in both the table and footnote definitions:
f to e
g to f

CARBAMAZEPINE EXTENDED-RELEASE TABLETS ASSAY/Procedure USP37–NF32 2123 01-Jun-2014 USP38–NF33 USP38–NF33
Line 2 of Sample stock solution B: Change
Standard stock solution
to:
Sample stock solution A

Line 2 of Sample stock solution B: Change
Standard stock solution
to:
Sample stock solution A

CHLOROXYLENOL IMPURITIES/Organic Impurities USP37–NF32 2308 01-Jun-2014 USP38–NF33 USP38–NF33
Line 12 of Analysis: Change
CS = concentration of 3,5-dimethylphenol or chloroxylenol related compound A in the Standard solution (mg/mL)
to:
CS = concentration of 3,5-dimethylphenol or USP Chloroxylenol Related Compound A RS in the Standard solution (mg/mL)

Line 12 of Analysis: Change
CS = concentration of 3,5-dimethylphenol or chloroxylenol related compound A in the Standard solution (mg/mL)
to:
CS = concentration of 3,5-dimethylphenol or USP Chloroxylenol Related Compound A RS in the Standard solution (mg/mL)

CHLOROXYLENOL ASSAY/Procedure USP37–NF32 2308 01-Jun-2014 USP38–NF33 USP38–NF33
Line 12 of Analysis: Change
CS = concentration of chloroxylenol in the Standard solution (mg/mL)
to:
CS = concentration of USP Chloroxylenol RS in the Standard solution (mg/mL)

Line 12 of Analysis: Change
CS = concentration of chloroxylenol in the Standard solution (mg/mL)
to:
CS = concentration of USP Chloroxylenol RS in the Standard solution (mg/mL)

CIPROFLOXACIN EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 2 First Supplement to USP37–NF32 6619 01-Jun-2014 USP38–NF33 USP38–NF33
Line 1 of Standard solution: Change
0.56 mg/mL of USP Ciprofloxacin Hydrochloride RS in Medium
to:
0.62 mg/mL of USP Ciprofloxacin Hydrochloride RS in Medium
AND
Line 8 of Analysis: Change
CS = concentration of ciprofloxacin in the Standard solution (mg/mL)
to:
CS = concentration of ciprofloxacin hydrochloride in the Standard solution (mg/mL)

Line 1 of Standard solution: Change
0.56 mg/mL of USP Ciprofloxacin Hydrochloride RS in Medium
to:
0.62 mg/mL of USP Ciprofloxacin Hydrochloride RS in Medium
AND
Line 8 of Analysis: Change
CS = concentration of ciprofloxacin in the Standard solution (mg/mL)
to:
CS = concentration of ciprofloxacin hydrochloride in the Standard solution (mg/mL)

CODEINE PHOSPHATE ORAL SOLUTION ASSAY/Procedure USP37–NF32 2451 01-Jun-2014 USP38–NF33 USP38–NF33
Line 6 of Analysis: Change
Result = (RU/RS) × (CS/CU) × 100
to:
Result = (RU/RS) × (CS/CU) × (Mr1/Mr2) × 100
AND
After CU in definition list: Add
Mr1 = molecular weight of codeine phosphate hemihydrate, 406.37
Mr2 = molecular weight of anhydrous codeine phosphate, 397.37

Line 6 of Analysis: Change
Result = (RU/RS) × (CS/CU) × 100
to:
Result = (RU/RS) × (CS/CU) ×
(Mr1/Mr2) ×

100

AND
After CU in definition list: Add
Mr1 = molecular weight of codeine phosphate hemihydrate, 406.37
Mr2 = molecular weight of anhydrous codeine phosphate, 397.37

XLS CSV