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PDF CSV October 4, 2022 through October 5, 2024 All Errata for USP–NF How to use
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Monograph Title Section Source Publication Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
RIBAVIRIN CAPSULES PERFORMANCE TESTS/Dissolution <711>/Procedure 1/Chromatographic system USP37–NF32 4562 1-Jun-2014 USP38–NF33 USP38–NF33 Line 1 of Column: Change
7-µm packing L17
to:
9-µm packing L17
DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLETS IMPURITIES/Limit of Ibuprofen Related Compound C USP37–NF32 2651 1-Jun-2014 USP38–NF33 USP38–NF33 Line 7 of Analysis: Change
RU = peak area ratio of ibuprofen to valerophenone from the Sample solution
RS = peak area ratio of ibuprofen to valerophenone from the Standard solution
to:
RU = peak area ratio of… Read More
SULFACETAMIDE SODIUM OPHTHALMIC SOLUTION ASSAY/Procedure USP37–NF32 4766 1-Jun-2014 USP38–NF33 USP38–NF33 Line 2 of Sample stock solution: Change
sulfacetamide
to:
sulfacetamide sodium
AND
Line 1 of Sample solution: Change
sulfacetamide
to:
sulfacetamide sodium
GRISEOFULVIN CAPSULES PERFORMANCE TESTS/Uniformity of Dosage Units <905>/Procedure for content uniformity USP37–NF32 3196 1-Jun-2014 USP38–NF33 USP38–NF33 Line 6 of Analysis: Change
Result = (AU/AS) × (CS/CU) × P × 100
to:
Result = (AU/AS) × (CS/CU) × P × F × 100
AND… Read More
VALSARTAN ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP37–NF32 5115 1-Jun-2014 USP38–NF33 USP38–NF33 Line 2 of USP Valsartan Related Compound A RS: Change
(R)-N-Valeryl-N-([2′-(1H-tetrazole-5-yl)biphen-4-yl]methyl)valine.
to:
N-Valeryl-N-{[2′-(1H-tetrazole-5-yl)biphenyl-4-yl]methyl}-D-valine.
AND
Line 2 of USP Valsartan Related… Read More
LAMIVUDINE AND ZIDOVUDINE TABLETS IMPURITIES/Organic Impurities USP37–NF32 3484 1-Jun-2014 USP38–NF33 USP38–NF33 Line 12 of Analysis: Change
unidentified impurity
to:
unspecified impurity
AND
Line 19 of Analysis: Change
unidentified impurities
to:
unspecified impurities
POWDERED ECHINACEA PALLIDA ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP37–NF32 5356 1-Jun-2014 USP38–NF33 USP38–NF33 Line 5: Change
USP Powdered Echinacea purpurea Extract RS
to:
USP Powdered Echinacea pallida Extract RS
NYSTATIN DEFINITION USP37–NF32 4035 1-Jun-2014 USP38–NF33 USP38–NF33 Line 6: Change
extemporaneous solution
to:
extemporaneous preparation
HOLY BASIL LEAF COMPOSITION/Content of Triterpenes USP37–NF32 5454 1-Jun-2014 USP38–NF33 USP38–NF33 Line 4 of Standard solution B: Change
0.45-μL
to:
0.45-μm
DESCRIPTION AND SOLUBILITY Sodium Acetate USP37–NF32 1525 1-Jun-2014 USP38–NF33 USP38–NF33 Line 7: Change
transfer liquid.
to:
transfer ligand.
PROGESTERONE VAGINAL SUPPOSITORIES ASSAY/Suppositories in Fatty Acid Base USP37–NF32 4430 1-Jun-2014 USP38–NF33 USP38–NF33 Line 1 of System suitability solution: Change
Transfer 2.0 mL of System suitability stock solution A and System suitability stock solution B
to:
Transfer 2.0 mL of each System suitability stock solution A and System suitability stock solution B
AND… Read More
CIPROFLOXACIN EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 2 First Supplement to USP37–NF32 6619 1-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… Read More
AMINOSALICYLATE SODIUM ASSAY/Procedure USP37–NF32 1745 1-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)
QUINIDINE GLUCONATE DEFINITION USP37–NF32 4512 1-Jun-2014 USP38–NF33 USP38–NF33 Line 6: Change
quinidine sulfate
to:
quinidine gluconate
CODEINE PHOSPHATE ORAL SOLUTION ASSAY/Procedure USP37–NF32 2451 1-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 Read More
SUFENTANIL CITRATE INJECTION ASSAY/Procedure USP37–NF32 4759 1-Jun-2014 USP38–NF33 USP38–NF33 Line 11 of Analysis: Change
sufentanil
to:
sufentanil citrate
FOSPHENYTOIN SODIUM INJECTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP37–NF32 3096 1-Jun-2014 USP38–NF33 USP38–NF33 Before USP Fosphenytoin Sodium RS: Add
USP Endotoxin RS
TRIACETIN ASSAY/Procedure/Titrimetric system USP37–NF32 5031 1-Jun-2014 USP38–NF33 USP38–NF33 Line 2: Change
(See Titrimetry <541>, Residual Titrations.)
to:
(See Titrimetry <541>.)
AND
Line 1 of Mode: Change
Direct titration
to:
Residual titration
HYDROCHLOROTHIAZIDE TABLETS IMPURITIES/Organic Impurities USP37–NF32 3247 1-Jun-2014 USP38–NF33 USP38–NF33 Line 11 of Analysis: Change
CU = concentration of the Sample solution (μg/mL)
to:
CU = nominal concentration of hydrochlorothiazide in the Sample solution (μg/mL)
POWDERED ECHINACEA ANGUSTIFOLIA EXTRACT ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP37–NF32 5350 1-Jun-2014 USP38–NF33 USP38–NF33 Line 5: Change
USP Powdered Echinacea purpurea Extract RS
to:
USP Powdered Echinacea angustifolia Extract RS
METHADONE HYDROCHLORIDE ORAL SOLUTION OTHER COMPONENTS USP37–NF32 3744 1-Jun-2014 USP38–NF33 USP38–NF33 Line 3 of Alcohol Determination: Change
gas–liquid chromatographic procedure
to:
gas chromatographic procedure
POWDERED DECAFFEINATED GREEN TEA EXTRACT COMPOSITION/Content of Polyphenols/Chromatographic system USP37–NF32 5438 1-Jun-2014 USP38–NF33 USP38–NF33 Line 1 of Column: Change
4.6-mm 6 25-cm;
to:
4.6-mm × 25-cm;
DESCRIPTION AND SOLUBILITY Potassium Alginate USP37–NF32 1520 1-Jun-2014 USP38–NF33 USP38–NF33 Line 6: Change
suspending and/or viscosity agent.
to:
suspending and/or viscosity-increasing agent.
OXCARBAZEPINE TABLETS IMPURITIES USP37–NF32 4119 1-Jun-2014 USP38–NF33 USP38–NF33 Row 5 of Column 1 of Table 1: Change
Methoxydibenzazepineb
to:
Methoxycarbamazepineb
ORANGE OIL ASSAY/Total Aldehyde Content USP37–NF32 6091 1-Jun-2014 USP38–NF33 USP38–NF33 Line 1 of Sample: Change
5 mL of Oil
to:
5 mL of Orange Oil, accurately weighed
ALUMINA, MAGNESIA, CALCIUM CARBONATE, AND SIMETHICONE CHEWABLE TABLETS ASSAY/Magnesium Hydroxide USP37–NF32 1674 1-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… Read More
PYRANTEL PAMOATE OTHER COMPONENTS/Content of Pamoic Acid USP37–NF32 4491 1-Jun-2014 USP38–NF33 USP38–NF33 Line 1 of Mobile phase: Change
acetic acid
to:
glacial acetic acid
CHLOROXYLENOL ASSAY/Procedure USP37–NF32 2308 1-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)
RITONAVIR IMPURITIES USP37–NF32 4601 1-Jun-2014 USP38–NF33 USP38–NF33 Row 13 of Column 1 of Table 2: Change
3-Epimerm
to:
3R-Epimerm
AND
Row 16 of Column 1 of Table 2: Change
5-Epimerp
to:
5R-Epimerp
AND
Row 17 of Column 1 of Table 2: Change
Valine urea… Read More
DOXEPIN HYDROCHLORIDE ORAL SOLUTION ASSAY/Procedure USP37–NF32 2713 1-Jun-2014 USP38–NF33 USP38–NF33 Line 1 of Standard solution: Change
Dilute 4.0 of Standard stock solution
to:
Dilute 4.0 mL of Standard stock solution
TAMSULOSIN HYDROCHLORIDE CAPSULES PERFORMANCE TESTS/Dissolution <711>/Test 4 USP37–NF32 4830 1-Jun-2014 USP38–NF33 USP38–NF33 Line 9 of the second calculation: Change
V = volume of Buffer stage medium, 1000 mL
to:
V = volume of Buffer stage medium, 500 mL
GRISEOFULVIN TABLETS ASSAY/Procedure USP37–NF32 3198 1-Jun-2014 USP38–NF33 USP38–NF33 Line 13 of Analysis: Change
P = potency of griseofulvin in USP Griseofulvin RS (μg/mL)
to:
P = potency of griseofulvin in USP Griseofulvin RS (μg/mg)
ECHINACEA ANGUSTIFOLIA ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP37–NF32 5343 1-Jun-2014 USP38–NF33 USP38–NF33 Line 5: Change
USP Powdered Echinacea purpurea Extract RS
to:
USP Powdered Echinacea angustifolia Extract RS
LINDANE CREAM ASSAY/Procedure/Chromatographic system/Temperatures USP37–NF32 3561 1-Jun-2014 USP38–NF33 USP38–NF33 After the Injection port subsection: Add a new subsection
Detector: 250°
POWDERED ECHINACEA PALLIDA EXTRACT ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP37–NF32 5359 1-Jun-2014 USP38–NF33 USP38–NF33 Line 5: Change
USP Powdered Echinacea purpurea Extract RS
to:
USP Powdered Echinacea pallida Extract RS
DESCRIPTION AND SOLUBILITY Carmellose USP37–NF32 1486 1-Jun-2014 USP38–NF33 USP38–NF33 Line 4: Change
Suspending and/or viscosity increasing agent;
to:
Suspending and/or viscosity-increasing agent;
OLMESARTAN MEDOXOMIL CHEMICAL INFORMATION USP37–NF32 4057 1-Jun-2014 USP38–NF33 USP38–NF33 Line 3 of the chemical name: Change
methyl ester
to:
methyl ester;
(5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 1-{[2′-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-4-(2-hydroxypropan-2-yl)-2-propyl-1H-imidazole-5-carboxylate
POWDERED HOLY BASIL LEAF COMPOSITION/Content of Triterpenes USP37–NF32 5456 1-Jun-2014 USP38–NF33 USP38–NF33 Line 4 of Standard solution B: Change
0.45-μL
to:
0.45-μm
ACETAMINOPHEN SUPPOSITORIES ASSAY/Procedure USP37–NF32 1567 1-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
PSEUDOEPHEDRINE HYDROCHLORIDE, CARBINOXAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION Microbial enumeration tests <61> and Tests for specified microorganisms <62> USP37–NF32 4486 1-Jun-2014 USP38–NF33 USP38–NF33 Line 3: Change
does not exceed 100 per g, the total combined molds and yeasts count does not exceed 10 per g,
to:
does not exceed 102 cfu/g, the total combined molds and yeasts count does not exceed 101 cfu/g,
PHENYTOIN SODIUM INJECTION OTHER COMPONENTS/Alcohol and Propylene Glycol Content First Supplement to USP37–NF32 6684 1-Jun-2014 USP38–NF33 USP38–NF33 Line 3 of Standard solution: Change
Internal standard stock solution
to:
Internal standard solution
<81> ANTIBIOTICS—MICROBIAL ASSAYS Turbidimetric Method USP36–NF31 76 1-Apr-2014 USP38–NF33 USP38–NF33 Line 9 of Paragraph 2 of Analysis: Change
or a water bath maintained at the temperature specified in Table 8 and for the time specified in Table 11.
to:
or a water bath maintained at 36.0° –37.5° for the time specified in Table 11.
ONDANSETRON ORAL SOLUTION Related compounds USP36–NF31 4586 1-Apr-2014 USP38–NF33 USP38–NF33 Line 7 of Procedure: Change
(293.36/329.82)10,000(1 / F)(1 / V)(CS / CA)(ri / rS)
to:
(293.36 / 329.83)10,000(1 / F)(1 / V)(CS / CA)(ri… Read More
ATROPINE SULFATE INJECTION ASSAY/Procedure First Supplement to USP36–NF31 5950 1-Apr-2014 USP38–NF33 USP38–NF33 Line 1 of Buffer: Change
Dissolve 4.1 g of sodium acetate and
to:
Dissolve 4.1 g of anhydrous sodium acetate and
<795> PHARMACEUTICAL COMPOUNDING—NONSTERILE PREPARATIONS COMPOUNDING FACILITIES Revision Bulletin (Official January 01, 2014) Online 1-Apr-2014 Second Supplement to USP37–NF32 Second Supplement to USP37–NF32 Line 4 of Paragraph 4: Change
(see the General Notices and Requirements, Preservation, Packaging, Storage, and Labeling, Storage Temperature and Humidity;
to:
(see Packaging and Storage Requirements <659>;
CLINDAMYCIN PALMITATE HYDROCHLORIDE ASSAY/Procedure USP36–NF31 3031 1-Apr-2014 USP38–NF33 USP38–NF33 Line 1 of Acceptance criteria: Change
NLT 540 μg
to:
NLT 540 μg/mg
THALIDOMIDE CAPSULES Dissolution <711> USP36–NF31 5347 1-Apr-2014 USP38–NF33 USP38–NF33 After the Test solution section: Add
to:
Chromatographic system—Prepare as directed in the Assay under Thalidomide.
CALCIUM SULFATE ASSAY/Procedure First Supplement to USP36–NF31 Online 1-Apr-2014 USP38–NF33 USP38–NF33 Line 14 of Analysis: Change
Result = [(V × N × F)/W] × 100
to:
Result = [(V × M × F)/W] × 100
AND
Line 15 of Analysis: Change
V = volume of titrant consumed by the Sample (mL)
N = actual… Read More
Sodium Sulfite, Anhydrous REAGENTS/Reagent Specifications USP36–NF31 1196 1-Apr-2014 USP38–NF33 USP38–NF33 Line 2: Change
[7753-83-7]
to:
[7757-83-7]
ONDANSETRON ORAL SOLUTION Assay USP36–NF31 4586 1-Apr-2014 USP38–NF33 USP38–NF33 Line 7 of Procedure: Change
(293.36/329.82)100(C/V)(rU / rS)
to:
(293.36 / 329.83)100(C / V)(rU / rS)
AND
Line 8 of Procedure: Change
329.82
to:
329.83