Errata - English

PDF CSV September 15, 2023 through September 15, 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
ECHINACEA PALLIDA ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP37–NF32 5353 30-May-2014 1-Jun-2014 USP38–NF33 USP38–NF33 Line 5: Change
USP Powdered Echinacea purpurea Extract RS
to:
USP Powdered Echinacea pallida Extract RS
POWDERED ECHINACEA PALLIDA ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP37–NF32 5356 30-May-2014 1-Jun-2014 USP38–NF33 USP38–NF33 Line 5: Change
USP Powdered Echinacea purpurea Extract RS
to:
USP Powdered Echinacea pallida Extract RS
POWDERED ECHINACEA PALLIDA EXTRACT ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP37–NF32 5359 30-May-2014 1-Jun-2014 USP38–NF33 USP38–NF33 Line 5: Change
USP Powdered Echinacea purpurea Extract RS
to:
USP Powdered Echinacea pallida Extract RS
POWDERED ECHINACEA PURPUREA EXTRACT COMPOSITION USP37–NF32 5371 30-May-2014 1-Jun-2014 USP38–NF33 USP38–NF33 Line 14 of Analysis in Content of Total Phenols: Change
CS = concentration of the relevant analyte in the corresponding Standard solution
CU = concentration of Echinacea purpurea in the Sample solution (mg/mL)
to:… Read More
POWDERED DECAFFEINATED GREEN TEA EXTRACT COMPOSITION/Content of Polyphenols/Chromatographic system USP37–NF32 5438 30-May-2014 1-Jun-2014 USP38–NF33 USP38–NF33 Line 1 of Column: Change
4.6-mm 6 25-cm;
to:
4.6-mm × 25-cm;
POWDERED DECAFFEINATED GREEN TEA EXTRACT SPECIFIC TESTS USP37–NF32 5438 30-May-2014 1-Jun-2014 USP38–NF33 USP38–NF33 Line 5 of Analysis in Limit of Gallic Acid: Change
Separately calculate the percentages of gallic acid
to:
Calculate the percentage of gallic acid
AND
Line 5 of Analysis in Limit of Caffeine: Change
Separately calculate the percentages of caffeine
… Read More
HOLY BASIL LEAF COMPOSITION/Content of Triterpenes USP37–NF32 5454 30-May-2014 1-Jun-2014 USP38–NF33 USP38–NF33 Line 4 of Standard solution B: Change
0.45-μL
to:
0.45-μm
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
POWDERED HOLY BASIL LEAF EXTRACT COMPOSITION/Content of Triterpenes USP37–NF32 5458 30-May-2014 1-Jun-2014 USP38–NF33 USP38–NF33 Line 4 of Standard solution B: Change
0.45-μL
to:
0.45-μm
ORANGE OIL ASSAY/Total Aldehyde Content USP37–NF32 6091 30-May-2014 1-Jun-2014 USP38–NF33 USP38–NF33 Line 1 of Sample: Change
5 mL of Oil
to:
5 mL of Orange Oil, accurately weighed
ATROPINE SULFATE IMPURITIES First Supplement to USP37–NF32 6591 30-May-2014 1-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
CIPROFLOXACIN EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 2 First Supplement to USP37–NF32 6619 30-May-2014 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
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.
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]
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
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
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
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
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
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
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.
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)
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
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°
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.
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
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
<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>;
<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>)
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
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
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
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)
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
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
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
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.
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)
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:
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
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
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
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
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,
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
<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
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
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)
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