How to Use the USP–NF Errata Table

  • Searching: Type keyword in search field at top of page. Search by all or part of a monograph title. For searches using multiple criteria, you will find items that match each of the specified criteria unless quotation marks are used.
    • For example, a search on Aminosalicylic Acid Tablets will result in anything that contains “Aminosalicyclic” OR “Acid” OR “Tablets”
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Monograph Title Section Source Publication Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
BETAMETHASONE SODIUM PHOSPHATE IMPURITIES/Limit of Free Betamethasone USP37–NF32 1965 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Line 1 of Sample stock solution: Change
1.0 mg/mL of Betamethasone Sodium Phosphate in water
to:
1.0 mg/mL of Betamethasone Sodium Phosphate in water, prepared as follows. Dissolve 25.0 mg of Betamethasone Sodium Phosphate in water to make 25.0 mL.


Line 1 of Sample stock solution: Change
1.0 mg/mL of Betamethasone Sodium Phosphate in water

to:
1.0 mg/mL of Betamethasone Sodium Phosphate in water, prepared as follows. Dissolve 25.0 mg of Betamethasone Sodium Phosphate in water to make 25.0 mL.

CALCIUM GLUCONATE INJECTION Identification USP37–NF32 2089 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Line 1 of Identification test A: Change
A volume of Injection diluted, if necessary, with water to obtain a test solution of calcium gluconate (1 in 100) responds to Identification test B under Calcium Gluconate.
to:
Dissolve a quantity of it in water to obtain a test solution containing 10 mg per mL, heating in a water bath at 60° if necessary. Similarly, prepare a Standard solution of USP Potassium Gluconate RS in water containing 10 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, and allow to dry. Develop the chromatogram in a solvent system consisting of a mixture of alcohol, water, ammonium hydroxide, and ethyl acetate (50: 30: 10: 10) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, and dry at 110° for 20 minutes. Allow to cool, spray with a spray reagent prepared as follows. Dissolve 2.5 g of ammonium molybdate in about 50 mL of 2 N sulfuric acid in a 100-mL volumetric flask, add 1.0 g of ceric sulfate, swirl to dissolve, dilute with 2 N sulfuric acid to volume, and mix. Heat the plate at 110° for about 10 minutes: the principal spot obtained from the test solution corresponds in color, size, and RF value to that obtained from the Standard solution.


Line 1 of Identification test A: Change
A volume of Injection diluted, if necessary, with water to obtain a test solution of calcium gluconate (1 in 100) responds to Identification test B under Calcium Gluconate.
to:
Dissolve a quantity of it in water to obtain a test solution containing 10 mg per mL,
heating in a water bath at 60° if necessary. Similarly, prepare a Standard solution of USP Potassium Gluconate RS in water containing 10 mg per mL.

Read more
CELLACEFATE ASSAY/Content of Acetyl USP37–NF32 5919 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Line 12 of Analysis:
Result = {[(P − 0.5182 × B)/(100 − B)] − (0.5772 × C)} × 100
to:
Result = 100 × [P − (0.5182 × B)]/(100 − B) − (0.5772 × C)


Line 12 of Analysis:
Result = {[(P − 0.5182 × B)/(100 − B)] − (0.5772 × C)} × 100
to:
Result =
100 × [P − (0.5182 × B)]/(100 − B) − (0.5772 × C)

CHLORPHENIRAMINE MALEATE IMPURITIES/Organic Impurities First Supplement to USP37–NF32 6617 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Line 1 of Standard solution: Change
1.1 μg/mL of USP Chlorpheniramine Maleate RS in Diluent,
to:
1.4 μg/mL of USP Chlorpheniramine Maleate RS in Diluent,


Line 1 of Standard solution: Change
1.1 μg/mL of USP Chlorpheniramine Maleate RS in Diluent,

to:
1.4 μg/mL of USP Chlorpheniramine Maleate RS in Diluent,

DACARBAZINE USP Reference standards <11> USP37–NF32 2504 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Line 3 of USP Dacarbazine Related Compound B RS: Change
C4H3N5O 137.10
to:
C4H3N5O · H2O 155.12


Line 3 of USP Dacarbazine Related Compound B RS: Change
C4H3N5O 137.10
to:
C4H3N5O · H2O 155.12

DACARBAZINE FOR INJECTION IMPURITIES/Limit of 2-Azahypoxanthine Second Supplement to USP37–NF32 ONLINE 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Line 2 of Analysis: Change
2-azahypoxanthine monohydrate
to:
2-azahypoxanthine


Line 2 of Analysis: Change
2-azahypoxanthine monohydrate
to:
2-azahypoxanthine

DEXCHLORPHENIRAMINE MALEATE IMPURITIES/Organic Impurities First Supplement to USP37–NF32 6626 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Line 1 of Standard solution:
2.2 μg/mL of USP Dexchlorpheniramine Maleate RS in Diluent,
to:
2.8 μg/mL of USP Dexchlorpheniramine Maleate RS in Diluent,


Line 1 of Standard solution:
2.2 μg/mL of USP Dexchlorpheniramine Maleate RS in Diluent,
to:
2.8 μg/mL of USP Dexchlorpheniramine Maleate RS in Diluent,

DIDANOSINE DELAYED-RELEASE CAPSULES PERFORMANCE TESTS/Dissolution <711>/Analysis USP37–NF32 2603 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Line 11 of the variable definition list: Change
CS = concentration of didanosine in the Standard solution (mg/mL)
to:
CS = concentration of USP Didanosine Related Compound A RS in the Standard solution for the Acid stage or concentration of USP Didanosine RS in the Standard solution for the Buffer stage (mg/mL)


Line 11 of the variable definition list: Change
CS
= concentration of didanosine in the Standard solution (mg/mL)
to:
CS
= concentration of USP Didanosine Related Compound A RS in the Standard solution for the Acid stage or concentration of USP Didanosine RS in the Standard solution for the Buffer stage (mg/mL)

DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS IMPURITIES/Organic Impurities/Chromatographic system USP37–NF32 2739 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Line 2 of Detector 2: Change
Monitor the signal at 344 nm between 37 and 42 min.
to:
Monitor the signal at 344 nm for ethinyl estradiol related compound B (typically between 37 and 42 min).


Line 2 of Detector 2: Change
Monitor the signal at 344 nm between 37 and 42 min.
to:
Monitor the signal at 344 nm for ethinyl estradiol related compound B (typically between 37 and 42 min).

ESCITALOPRAM ORAL SOLUTION IMPURITIES/Organic Impurities USP37–NF32 2580 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Row 6 of Column 1 of Table 3: Change
Desfluorocitalopramf
to:
Desfluorocitalopramf,c


Row 6 of Column 1 of Table 3: Change
Desfluorocitalopramf

to:
Desfluorocitalopramf,c

ETHYLCELLULOSE DISPERSION TYPE B ASSAY/Procedure USP37–NF32 5981 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Line 3 of Analysis: Change
Calculate the percentage of ethylcellulose in the portion of Ethylcellulose Dispersion Type B taken:
to:
Calculate the percentage of the labeled amount of ethylcellulose in the portion of Ethylcellulose Dispersion Type B taken:


Line 3 of Analysis: Change
Calculate the percentage of ethylcellulose in the portion of
Ethylcellulose Dispersion Type B taken:
to:
Calculate the percentage of the labeled amount of ethylcellulose in the portion of Ethylcellulose Dispersion Type B taken:

IRINOTECAN HYDROCHLORIDE INJECTION IMPURITIES/Organic Impurities USP37–NF32 3403 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Row 3 of Column 1 of Table 2: Change
Camptothecinb
to:
Camptothecinb,d
AND
Row 5 of Column 1: Change
7-Ethylcamptothecinc
to:
7-Ethylcamptothecinc,d
AND
Add a footnote:
dThese process impurities are included in the table for identification only and are not included in the Total impurities.










Row 3 of Column 1 of Table 2: Change
Camptothecinb

to:
Camptothecinb,d

AND
Row 5 of Column 1: Change
7-Ethylcamptothecinc

to:
7-Ethylcamptothecinc,d

AND
Add a footnote:
dThese process impurities
are included in the table for identification only and are not included in the Total impurities.

KETOPROFEN EXTENDED-RELEASE CAPSULES PERFORMANCE TESTS/Uniformity of Dosage Units <905>/System suitability/Suitability requirements USP37–NF32 3469 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Line 1 of Tailing factor: Change
NLT 1.5
to:
NMT 1.5


Line 1 of Tailing factor: Change
NLT 1.5
to:
NMT 1.5

KETOPROFEN EXTENDED-RELEASE CAPSULES ASSAY/Procedure/System suitability/Suitability requirements USP37–NF32 3469 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Line 1 of Tailing factor: Change
NLT 1.5
to:
NMT 1.5


Line 1 of Tailing factor: Change
NLT 1.5
to:
NMT 1.5

OXYBUTYNIN CHLORIDE SPECIFIC TESTS/Loss on Drying <731> USP37–NF32 4129 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Line 1 of Acceptance criteria: Change
NMT 3.0%
to:
NMT 3%


Line 1 of Acceptance criteria: Change
NMT 3.0%
to:
NMT 3%

POWDERED CELLULOSE IDENTIFICATION/B. Procedure USP37–NF32 5923 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Fourth equation in Analysis: Change
Result = 95 × [η]c/WS × [(100 − %LOD)/100]
to:
Result = [95 × [η]c]/{WS × [(100 − %LOD)/100]}


Fourth equation in Analysis: Change
Result = 95 × [η]c/WS × [(100 − %LOD)/100]
to:
Result = [95 × [η]c]/{WS × [(100 − %LOD)/100]}

PSEUDOEPHEDRINE HYDROCHLORIDE ASSAY/Procedure USP37–NF32 4481 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Line 2 of System suitability solution: Change
0.02 mg/mL of USP Ephedrine Sulfate RS
to:
0.002 mg/mL of USP Ephedrine Sulfate RS


Line 2 of System suitability solution: Change
0.02 mg/mL of USP Ephedrine Sulfate RS
to:
0.002 mg/mL of USP Ephedrine Sulfate RS

PURE STEAM CHEMICAL INFORMATION USP37–NF32 5176 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Add the chemical formula and molecular weight:
H2O 18.02

Add the chemical formula and molecular weight:
H2O 18.02

STERILE PURIFIED WATER ADDITIONAL REQUIREMENTS USP37–NF32 5176 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Add a section:
USP Reference Standards <11>
USP 1,4-Benzoquinone RS
USP Sucrose RS


Add a section:

USP Reference Standards <11>

USP 1,4-Benzoquinone RS
USP Sucrose RS

STERILE WATER FOR INHALATION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP37–NF32 5174 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Add:
USP 1,4-Benzoquinone RS
AND
USP Sucrose RS




Add:
USP 1,4-Benzoquinone RS

AND
USP Sucrose RS

STERILE WATER FOR INHALATION CHEMICAL INFORMATION USP37–NF32 5174 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Add the chemical formula and molecular weight:
H2O 18.02

Add the chemical formula and molecular weight:
H2O 18.02

STERILE WATER FOR INJECTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP37–NF32 5175 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Add:
USP 1,4-Benzoquinone RS
AND
USP Sucrose RS


Add:
USP 1,4-Benzoquinone RS

AND
USP Sucrose RS

STERILE WATER FOR INJECTION CHEMICAL INFORMATION USP37–NF32 5175 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Add the chemical formula and molecular weight:
H2O 18.02

Add the chemical formula and molecular weight:
H2O 18.02

STERILE WATER FOR IRRIGATION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP37–NF32 5175 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Add:
USP 1,4-Benzoquinone RS
AND
USP Sucrose RS


Add:
USP 1,4-Benzoquinone RS

AND
USP Sucrose RS

STERILE WATER FOR IRRIGATION CHEMICAL INFORMATION USP37–NF32 5175 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Add the chemical formula and molecular weight:
H2O 18.02

Add the chemical formula and molecular weight:
H2O 18.02

WATER FOR HEMODIALYSIS CHEMICAL INFORMATION USP37–NF32 5173 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Add the chemical formula and molecular weight:
H2O 18.02

Add the chemical formula and molecular weight:
H2O 18.02

WATER FOR INJECTION CHEMICAL INFORMATION USP37–NF32 5173 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Add the chemical formula and molecular weight:
H2O 18.02

Add the chemical formula and molecular weight:
H2O 18.02

<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

XLS CSV