Errata - English

PDF CSV January 30, 2023 through January 31, 2025 All Errata for USP–NF How to use
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Monograph Title Section Source Publication Page Number Errata Post Date Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
POWDERED HOLY BASIL LEAF COMPOSITION/Content of Triterpenes USP37–NF32 5456 30-May-2014 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 30-May-2014 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 30-May-2014 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 30-May-2014 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 28-Mar-2014 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 28-Mar-2014 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 28-Mar-2014 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 28-Mar-2014 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 28-Mar-2014 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 28-Mar-2014 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 28-Mar-2014 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 28-Mar-2014 1-Apr-2014 USP38–NF33 USP38–NF33 Line 2: Change
[7753-83-7]
to:
[7757-83-7]
ONDANSETRON ORAL SOLUTION Assay USP36–NF31 4586 28-Mar-2014 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 28-Mar-2014 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 28-Mar-2014 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 28-Mar-2014 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 28-Mar-2014 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)
ONDANSETRON INJECTION Assay Second Supplement to USP36–NF31 Online 28-Mar-2014 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 28-Mar-2014 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 28-Mar-2014 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 28-Mar-2014 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.
OIL- AND WATER-SOLUBLE VITAMINS WITH MINERALS CAPSULES STRENGTH/Molybdenum, Method 1 Second Supplement to USP36–NF31 6372 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 2 of Standard solutions: Change
2.0
to:
5.0
GLYCERYL TRISTEARATE IDENTIFICATION/Fatty Acid Composition USP36–NF31 2033 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 19 of Analysis: Change
Result = [(FMC × PFA1 × AMC)/(PMC × AFA1)] × 100
to:
Result = (FMC × PFA1 ×… Read More
DICLOFENAC SODIUM DELAYED-RELEASE TABLETS IMPURITIES/Organic Impurities/Procedure USP36–NF31 3221 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 22 of Analysis: Change
rS = peak response for each impurity from the Standard solution
to:
rS = peak response of diclofenac related compound A from the Standard solution
TIZANIDINE TABLETS IMPURITIES/Organic Impurities/Procedure USP36–NF31 5408 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 9 of Sample solution: Change
45-µm or finer pore size
to:
0.45-µm or finer pore size
OXALIPLATIN INJECTION IMPURITIES/Limit of Oxalic Acid First Supplement to USP36–NF31 6033 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 3 of Analysis: Change
Calculate the percentage of each impurity
to:
Calculate the percentage of oxalic acid
WATER-SOLUBLE VITAMINS WITH MINERALS CAPSULES STRENGTH/Molybdenum, Method 1 Second Supplement to USP36–NF31 6479 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 2 of Standard solutions: Change
2.0
to:
5.0
CEFTAZIDIME FOR INJECTION Assay USP36–NF31 2887 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 6 of Procedure: Change
250,000[C/W (100 − m − s)](rU / rS)
to:
25,000{C/[W (100 − m − s)]}(rU / rS)
RIBOFLAVIN 5′-PHOSPHATE SODIUM IMPURITIES/Free Riboflavin and Riboflavin Diphosphates USP36–NF31 5037 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of Emission wavelength: Change
530 nm
to:
530 nm (monochromator-based detector) or 470 nm (filtered-type detector)
CYCLOMETHICONE ASSAY/Procedure/System suitability First Supplement to USP36–NF31 5909 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 2 of Suitability requirements: Change
Relative standard deviation: NMT 2.0% for cyclomethicone 4, cyclomethicone 5, and cyclomethicone 6, Standard solution A, Standard solution B, and Standard solution C
to:
Relative standard deviation: NMT… Read More
OIL- AND WATER-SOLUBLE VITAMINS WITH MINERALS ORAL SOLUTION STRENGTH/Chromium Second Supplement to USP36–NF31 6399 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 13 of Analysis: Change
C = concentration of chromium in the Standard solution (µg/mL)
to:
C = concentration of chromium in the Sample solution (µg/mL)
ANAGRELIDE HYDROCHLORIDE ASSAY/Procedure/Chromatographic system/System suitability USP36–NF31 2500 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 2 of Suitability requirements: Change
Column efficiency: NMT
to:
Column efficiency: NLT
DILTIAZEM HYDROCHLORIDE IMPURITIES/Organic Impurities USP36–NF31 3258 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 21 of Analysis: Change
rS = response of each impurity peak from the Standard solution
to:
rS = peak response of desacetyl diltiazem from the Standard solution
VANCOMYCIN HYDROCHLORIDE SPECIFIC TESTS/Composition of Vancomycin USP36–NF31 5543 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 28 of Analysis: Change
Result = [(rI/(D × rB) + rA)] × 100
to:
Result = {rI/[(D × rB) + rA]} × 100
<1660> CONTAINERS GLASS-EVALUATION OF INNER SURFACE DURABILITY EVALUATION OF THE INNER SURFACE DURABILITY/Aggressive Screening Conditions Second Supplement to USP36–NF31 6221 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Row 1 of Column 3 of Table 4: Change
3% Citric Acid pH 8.0
to:
3% Sodium Citrate pH 8.0
ISOPROPYL ALCOHOL ASSAY/Procedure Second Supplement to USP36–NF31 6638 31-Jan-2014 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 17 of Chromatographic system: Change
Linear velocity: 35 cm/s
to:
Flow rate: 2.3 mL/min
AND
Row 2 of Column 1 of Table 2: Change
Diethyl ether
to:
Ethyl ether
CLARITHROMYCIN ASSAY/Procedure/System suitability USP36–NF31 3016 31-Jan-2014 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 31-Jan-2014 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 31-Jan-2014 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 31-Jan-2014 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 31-Jan-2014 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 31-Jan-2014 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 31-Jan-2014 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
LACTATED RINGER'S INJECTION Definition USP36–NF31 5055 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 13: Change
408.0 mg of chloride
to:
428.0 mg of chloride
BUFFER SOLUTIONS 4. Standard Buffer Solutions/4.1 Preparation Second Supplement to USP36–NF31 6244 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of 4. Boric Acid and Potassium Chloride 0.2 M: Change
12.73 g/L of boric acid
to:
12.37 g/L of boric acid
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 5 Second Supplement to USP36–NF31 6592 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 3 of Acid stage sample solution: Change
suitable filter of 45-µm pore size.
to:
suitable filter of 0.45-µm pore size.
AND
Line 3 of Buffer stage sample solution: Change
suitable filter of 45-µm pore size.
to:
suitable filter of 0.45-µm pore size.
ALMOND OIL SPECIFIC TESTS/Sterol Composition USP36–NF31 1877 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Row 9 of Table 2: Change
Δ7-Stigmastenol ≥3.0%
to:
Δ7-Stigmastenol ≤3.0%
FLUOCINONIDE TOPICAL SOLUTION Alcohol content USP36–NF31 3618 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of Standard solution: Change
Dilute 20.0 mL of USP Alcohol
to:
Dilute 20.0 mL of alcohol
MINERAL OIL SPECIFIC TESTS USP36–NF31 4372 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of Viscosity—Capillary Viscometer Methods <911>: Change
34.5 and 150.0 mm2· s−1
to:
34.5–150.0 mm2· s−1
ATROPINE SULFATE SPECIFIC TESTS/Optical Rotation, Specific Rotation <781> First Supplement to USP36–NF31 5948 22-Nov-2013 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of Sample solution: Change
0.1 mg/mL in water
to:
0.1 g/mL of Atropine Sulfate in water