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Errata - English

PDF CSV November 24, 2022 through November 24, 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
POWDERED HOLY BASIL LEAF EXTRACT COMPOSITION/Content of Triterpenes USP37–NF32 5458 1-Jun-2014 USP38–NF33 USP38–NF33 Line 4 of Standard solution B: Change
0.45-μL
to:
0.45-μm
DESCRIPTION AND SOLUBILITY Lauric Acid USP37–NF32 1506 1-Jun-2014 USP38–NF33 USP38–NF33 Line 4: Change
emulsifying and/or solubilizing agent; tablet and/or capsule lubricant.
to:
emulsifying agent; lubricant.
PYRANTEL PAMOATE ASSAY/Procedure USP37–NF32 4491 1-Jun-2014 USP38–NF33 USP38–NF33 Line 1 of Mobile phase: Change
acetic acid
to:
glacial acetic acid
AND
Line 1 of Column efficiency: Change
NLT 8000 theoretical plates
to:
NLT 8000 theoretical plates for the pyrantel peak
ALCOHOL IN DEXTROSE INJECTION ASSAY/Dextrose USP37–NF32 1637 1-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)
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
CARBAMAZEPINE EXTENDED-RELEASE TABLETS ASSAY/Procedure USP37–NF32 2123 1-Jun-2014 USP38–NF33 USP38–NF33 Line 2 of Sample stock solution B: Change
Standard stock solution
to:
Sample stock solution A
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
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
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
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
DESCRIPTION AND SOLUBILITY Sodium Acetate USP37–NF32 1525 1-Jun-2014 USP38–NF33 USP38–NF33 Line 7: Change
transfer liquid.
to:
transfer ligand.
QUINIDINE GLUCONATE DEFINITION USP37–NF32 4512 1-Jun-2014 USP38–NF33 USP38–NF33 Line 6: Change
quinidine sulfate
to:
quinidine gluconate
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)
SUFENTANIL CITRATE INJECTION ASSAY/Procedure USP37–NF32 4759 1-Jun-2014 USP38–NF33 USP38–NF33 Line 11 of Analysis: Change
sufentanil
to:
sufentanil citrate
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
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
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
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
ONDANSETRON INJECTION Assay Second Supplement to USP36–NF31 Online 1-Apr-2014 USP38–NF33 USP38–NF33 Line 7 of Procedure: Change
(293.36 / 329.82)(25C / V)(rU / rS)
to:
(293.36 / 329.83)(25C / V)(rU / rS)
AND
Line 8 of Procedure: Change
329.82
to:
329.83
MAGNESIUM ALUMINUM SILICATE IMPURITIES/Arsenic, Method I <211> USP36–NF31 2073 1-Apr-2014 USP38–NF33 USP38–NF33 Line 1 of Standard preparation: Change
Prepare as directed in the chapter.
to:
Transfer 5.0 mL (5 μg of arsenic) of the Standard Arsenic Solution to a 25-mL volumetric flask, and add dilute hydrochloric acid (1:25) to volume.
AND
Delete:
Control preparation… Read More
SODIUM ACETATE IMPURITIES/Inorganic Impurities/Potassium USP36–NF31 5147 1-Apr-2014 USP38–NF33 USP38–NF33 Line 1 of Sample solution: Change
Equivalent to 600 mg/mL of anhydrous sodium acetate
to:
Dissolve the equivalent of 3 g of anhydrous sodium acetate in 5 mL of water.
AND
Line 1 of Analysis: Change
To 5 mL of Sample solution add
to:
To the Sample… Read More
CARBIDOPA AND LEVODOPA ORALLY DISINTEGRATING TABLETS ASSAY Second Supplement to USP36–NF31 6580 1-Apr-2014 USP38–NF33 USP38–NF33 Line 2 of Procedure: Change
Inject the Sample solution within 2 h of preparation. Protect the volumetric solutions from light.
to:
Protect the volumetric solutions from light.
<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
BUTYLPARABEN IMPURITIES/Related Substances/Chromatographic system Second Supplement to USP36–NF31 6551 1-Apr-2014 USP38–NF33 USP38–NF33 After the Column section: Add
Column temperature: 35°
<795> PHARMACEUTICAL COMPOUNDING— NONSTERILE PREPARATIONS STABILITY CRITERIA AND BEYOND-USE DATING/General Guidelines for Assigning Beyond-Use Dates Revision Bulletin (Official January 01, 2014) Online 1-Apr-2014 Second Supplement to USP37–NF32 Second Supplement to USP37–NF32 Line 7 of Paragraph 1: Change
(see the General Notices and Requirements, Preservation, Packaging, Storage, and Labeling)
to:
(see <659>)
MELPHALAN TABLETS Dissolution <711> USP36–NF31 4232 1-Apr-2014 USP38–NF33 USP38–NF33 Line 1 of Mobile phase: Change
Prepare a filtered and degassed mixture of water, acetonitrile, ammonium acetate, glacial acetic acid, and triethylamine (1500:500:2:2:0.4). Make adjustments if necessary (see System Suitability under Chromatography <621>).
to:
Read More
THIMEROSAL IMPURITIES/Mercury Ions USP36–NF31 5368 1-Apr-2014 USP38–NF33 USP38–NF33 Line 19 of Analysis:
CS = concentration of mercuric chloride in the Standard solution (mg/mL)
to:
CS = concentration of mercuric chloride in Sample solution B (mg/mL)
CLARITHROMYCIN ASSAY/Procedure/System suitability USP36–NF31 3016 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of Samples: Change
Standard solution 2 and Standard solution 4
to:
Standard solution 1, Standard solution 2, and Standard solution 4
AND
Line 13 of Suitability requirements: Change
Relative standard deviation: NMT 1.… Read More
RISPERIDONE TABLETS Dissolution <711> USP36–NF31 5065 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 4 of Chromatographic system: Change
Chromatograph the Standard solution and the Test solution as directed for Procedure:
to:
Chromatograph the Standard solution as directed for Procedure:
ATOMOXETINE HYDROCHLORIDE IMPURITIES/Organic Impurities, Procedure 2 First Supplement to USP36–NF31 5947 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 5 of System suitability solution: Change
dissolving the Reference Standards in ethanol,
to:
dissolving the Reference Standards in absolute alcohol,
AND
Line 2 of Sample solution: Change
dissolving it in ethanol,
to:
dissolving it in absolute alcohol,
OIL- AND WATER-SOLUBLE VITAMINS WITH MINERALS ORAL SOLUTION CONTAMINANTS Second Supplement to USP36–NF31 6399 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Add the test:
Absence of Specified Microorganisms <2022>: Meet the requirements of the tests for the absence of Salmonella species, Escherichia coli, and Staphylococcus aureus
CANDESARTAN CILEXETIL ASSAY/Procedure USP36–NF31 2774 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of Analysis: Change
Titrate with 8 mL of 0.1 N
to:
Titrate with 0.1 N
FENTANYL IMPURITIES/Organic Impurities/Acceptance criteria USP36–NF31 3554 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Footnote f of Table 2: Change
N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]acetanilide hydrochloride, or acetyl fentanyl.
to:
N-(1-Phenethylpiperidin-4-yl)-N-phenylacetamide.
VANCOMYCIN HYDROCHLORIDE FOR INJECTION SPECIFIC TESTS/Content of Vancomycin USP36–NF31 5546 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 27 of Analysis: Change
Result = [rI/(D × rB) + rA] × 100
to:
Result = {rI/[(D × rB) + rA]} × 100
OIL- AND WATER-SOLUBLE VITAMINS WITH MINERALS CAPSULES STRENGTH/Molybdenum, Method 1 Second Supplement to USP36–NF31 6372 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 2 of Standard solutions: Change
2.0
to:
5.0