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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 Post Date Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
QUETIAPINE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 3 USP38–NF33 5104 27-Mar-2015 1-Apr-2015 USP39–NF34 USP39–NF34 Line 7 of Instrumental conditions: Change
10 0mg,
to:
100 mg,
AND
Line 5 of Tolerances: Change
For Tablets labeled to contain 100 mg, 200 mg, 300 mg, or 400 mg:
to:
For Tablets labeled to contain 50 mg, 100 mg, 200 mg, 300 mg, or 400 mg:
PHENYTOIN SODIUM USP Reference standards <11> USP37–NF32 4289 27-Mar-2015 1-Apr-2015 USP39–NF34 USP39–NF34 Line 3 of USP Phenytoin Related Compound A RS: Change
C14H15NO2
to:
C14H13NO2
SORBITOL SORBITAN SOLUTION SPECIFIC TESTS USP37–NF32 6197 27-Mar-2015 1-Apr-2015 USP39–NF34 USP39–NF34 Line 1 of pH <791>: Change
4.0–7.0, in a 14% solution of Sorbitol Sorbitan Solution in carbon dioxide-free water
to:
4.0–7.0, in a 14% (w/w) solution of Sorbitol Sorbitan Solution in carbon dioxide-free water
MINERAL OIL SPECIFIC TESTS/Readily Carbonizable Substances Test <271> Second Supplement to USP37–NF32 Online 27-Mar-2015 1-Apr-2015 USP39–NF34 USP39–NF34 Line 1 of Acceptance criteria: Change
The Sample may turn hazy, but it remains colorless, or shows a slight pink or yellow color, and the Sample does not become darker than the Standard solution.
to:
The oil portion of the Sample may turn hazy, but it… Read More
COSYNTROPIN SPECIFIC TESTS/UV Absorption Spectrophotometry USP38–NF33 2958 27-Mar-2015 1-Apr-2015 USP39–NF34 USP39–NF34 Line 1 of Sample solution: Change
hydrochloride
to:
hydrochloric acid
AMINOBENZOIC ACID IMPURITIES/Organic Impurities USP37–NF32 1730 27-Mar-2015 1-Apr-2015 USP39–NF34 USP39–NF34 Add the subsection:
Standard stock solution: 0.25 mg/mL each of USP Benzocaine RS and 4-nitrobenzoic acid in methanol
AND
Line 2 of Standard solution: Change
in Mobile phase
to:
in Mobile phase, from the Standard stock solution
ASPARTAME ASSAY/Procedure USP37–NF32 5857 27-Mar-2015 1-Apr-2015 USP39–NF34 USP39–NF34 Line 3 of Analysis: Change
crystal violet
to:
crystal violet TS
RIVASTIGMINE TARTRATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> First Supplement to USP37–NF32 Online 27-Mar-2015 1-Apr-2015 USP39–NF34 USP39–NF34 Line 2 of USP Rivastigmine Related Compound A RS: Change
Di-p-toluoyl-D-(+)-tartaric acid monohydrate.
C20H20O9 404.37
to:
(+)-Di-(p-toluoyl)-D-tartaric acid.
C20H18O8 386.35
CLARITHROMYCIN TABLETS IMPURITIES/Organic Impurities/Chromatographic system USP38–NF33 2850 27-Mar-2015 1-Apr-2015 USP39–NF34 USP39–NF34 Line 1 of Column: Change
4.6-mm × 10-cm; 3-µm packing L1
to:
4.6-mm × 10-cm; 3.5-µm packing L1
RIVASTIGMINE TARTRATE CAPSULES ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP37–NF32 4616 27-Mar-2015 1-Apr-2015 USP39–NF34 USP39–NF34 Line 2 of USP Rivastigmine Related Compound A RS: Change
Di-p-toluoyl-D-(+)-tartaric acid monohydrate.
C20H20O9 404.37
to:
(+)-Di-(p-toluoyl)-D-tartaric acid.
C20H18O8 386.35
TREHALOSE IMPURITIES/Heavy Metals, Method I <231> USP37–NF32 6247 27-Mar-2015 1-Apr-2015 USP39–NF34 USP39–NF34 Line 1 of Monitor preparation: Change
Prepare with 2.5 mL of Standard Lead Solution.
to:
Prepare with 2.0 mL of Standard Lead Solution.
BISMUTH SUBCARBONATE IMPURITIES/Limit of Lead USP38–NF33 2449 27-Mar-2015 1-Apr-2015 USP39–NF34 USP39–NF34 Line 1 of Acceptance criteria: Change
Meets the requirements
to:
NMT 0.002%
QUETIAPINE FUMARATE IMPURITIES/Organic Impurities USP38–NF33 5102 27-Mar-2015 1-Apr-2015 USP39–NF34 USP39–NF34 Line 2 of Peak identification solution: Change
USP Quetiapine Fumarate Related Compound B RS
to:
USP Quetiapine Related Compound B RS
AND
Line 3 of Peak identification solution: Change
USP Quetiapine Fumarate Related Compound G RS
to:
USP Quetiapine Related… Read More
BETAMETHASONE DIPROPIONATE ASSAY/Procedure USP37–NF32 1961 27-Mar-2015 1-Apr-2015 USP39–NF34 USP39–NF34 Line 2 of Sample solution: Change
5.0 mL each of the Internal standard solution and the Standard stock solution
to:
5.0 mL each of the Internal standard solution and the Sample stock solution
PURIFIED BENTONITE IDENTIFICATION/A. X-Ray Diffraction <941> USP37–NF32 5862 27-Mar-2015 1-Apr-2015 USP39–NF34 USP39–NF34 Line 4 of Acceptance criteria: Change
from the pattern of Sample B is 1.492 and 1.504 Å.
to:
from the pattern of Sample B is between 1.492 and 1.504 Å.
RED CLOVER TABLETS SPECIFIC TESTS/Microbial Enumeration Tests <2021> USP37–NF32 5526 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 4: Change
NLT 103 cfu/g.
to:
NMT 103 cfu/g.
ATROPINE SULFATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP38–NF33 2325 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 2 of USP Hyoscyamine Related Compound A RS: Change
Norhyoscyamine sulfate; (1R,3r,5S)-8-azabicyclo [3.2.1]oct-3-yl(2S)-3-hydroxy-2-phenylpropanoate.C16H21NO3 275.34
to:
Norhyoscyamine sulfate; (1R,3r,5… Read More
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLETS ASSAY/Procedure USP38–NF33 2752 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Buffer: Change
0.20 sodium hydroxide
to:
0.20 N sodium hydroxide
PAROXETINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP38–NF33 4765 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Lines 4 and 7 of USP Paroxetine System Suitability Mixture A RS: Change
hydrochloride (3 S-trans)
to:
hydrochloride (3S-trans)
GADOVERSETAMIDE INJECTION Relaxivity <761> USP37–NF32 3121 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Apparatus: Change
Use a mini-NMR spectrometer with suitable sensitivity (see Apparatus under Nuclear Magnetic Resonance <761>).
to:
Use an NMR spectrometer with suitable sensitivity.
BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS IMPURITIES/Organic Impurities Revision Bulletin (Official October 01, 2014) Online 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Row 4 of Column 1 of Table 16: Change
R,S,S,-Thiomorpholine derivativec
to:
S,R,R,-Thiomorpholine derivativec
PANCURONIUM BROMIDE ASSAY/Procedure/Chromatographic system USP37–NF32 4176 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Column: Change
4.6-mm × 250-cm; 5-µm packing L1
to:
4.6-mm × 25-cm; 5-µm packing L1
VALSARTAN TABLETS PERFORMANCE TESTS/Dissolution <711> USP37–NF32 5116 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Medium: Change
pH 6.8 phosphate buffer; 1000 mL, degassed
to:
pH 6.8 phosphate buffer prepared as follows. Dissolve 6.805 g of monobasic potassium phosphate and 0.896 g of sodium hydroxide in and dilute with water to 1000 mL. Adjust with 0.2 M sodium hydroxide or 1 M… Read More
RISPERIDONE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP37–NF32 7240 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 2 of USP Risperidone Related Compound G RS: Change
3-[2-[4-(4-Fluoro-2-hydroxybenzoyl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one.
C23H28FN3O3 413.49
to:
3-[2-[4-(4-… Read More
CAFFEINE CITRATE INJECTION ASSAY/Procedure USP38–NF33 2520 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 5 of Analysis: Change
Result = (rU/rS) × CS × (Mr1/Mr2) × 100
to:
Result = (rU/rS) × C… Read More
MESALAMINE RECTAL SUSPENSION OTHER COMPONENTS/Content of Sodium Benzoate (if present) USP38–NF33 4270 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 5 of Analysis: Change
Result = (rU/rS) × CS × (10/W) × 100
to:
Result = (rU/rS) × CS × (10/W)
CHLORAMPHENICOL SODIUM SUCCINATE Limit of free chloramphenicol USP37–NF32 2285 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 10 of Chromatographic system: Change
Chromatograph the Standard solution, and record the peak areas as directed for Procedure: the relative standard deviation for replicate injections is not less than 2.0%.
to:
Chromatograph the Standard solution, and… Read More
CIPROFLOXACIN EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711> Revision Bulletin (Official October 01, 2014) Online 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 13 of Analysis in Test 1: Change
Mr2 = molecular weight of ciprofloxacin hydrochloride, 367.81
to:
Mr2 = molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81
AND
Line 12 of Analysis in Test… Read More
METHOTREXATE IMPURITIES/Organic Impurities/Procedure 1: Related Compounds USP37–NF32 3762 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Standard solution A: Change
0.1 μg/mL of USP Methotrexate RS in Solution A, from the Standard stock solution
to:
0.1 µg/mL of USP Methotrexate RS in Solution A, from Standard stock solution A
TERAZOSIN TABLETS PERFORMANCE TESTS/Dissolution <711> USP37–NF32 4874 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 10 of Analysis: Change
Mr2 = molecular weight of terazosin hydrochloride dihydrate, 459.92
to:
Mr2 = molecular weight of terazosin hydrochloride, 423.89
EXTENDED PHENYTOIN SODIUM CAPSULES IDENTIFICATION/A. Infrared Absorption—General <197> First Supplement to USP37–NF32 6681 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Sample: Change
6 mg/mL of phenytoin sodium in water from a suitable number of Capsules prepared as follows. Nominally transfer 300 mg of the powder into 50 mL of water in a separator.
to:
300 mg of phenytoin sodium from the contents of Capsules in 50 mL of water in a… Read More
BUTABARBITAL SODIUM ORAL SOLUTION ASSAY/Procedure USP38–NF33 2500 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 17 of Analysis: Change
CU = nominal concentration of butabarbital sodium in the Sample solution (µg/mL)
to:
CU = nominal concentration of butabarbital sodium in the Sample solution (mg/mL)
CITRIC ACID, MAGNESIUM OXIDE, AND SODIUM CARBONATE IRRIGATION ASSAY/Citric Acid USP38–NF33 2844 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 16 of Analysis: Change
CU = nominal concentration of citric acid monohydrate in the Assay preparation for citric acid/citrate assay (units/mL)
to:
CU = nominal concentration of citric acid monohydrate in the Assay… Read More
AZITHROMYCIN IMPURITIES/Organic Impurities/Procedure 1 USP37–NF32 1886 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 6 of Analysis: Change
Calculate the percentages of desosaminylazithromycin and N-demethylazithromycin in the portion of Azithromycin taken:
to:
Calculate the percentages of desosaminylazithromycin, N-demethylazithromycin, and azaerythromycin A in the portion of… Read More
VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Revision Bulletin (Official April 01, 2014) Online 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 2 of USP Valsartan Related Compound B RS: Change
(S-N-Butyryl-N-([2′-(1H-tetrazole-5-yl)biphen-4-yl]methyl)-valine.
to:
N-Butyryl-N-{[2′-(1H-tetrazole-5-yl)biphenyl-4-yl]methyl}-L-valine.
HYDROGEN PEROXIDE CONCENTRATE ASSAY/Procedure USP37–NF32 3272 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Sample solution: Change
1 mL of Concentrate, diluted to 100 mL
to:
Weigh about 1 mL of Concentrate in a 100-mL volumetric flask, and dilute with water to volume.
POTASSIUM BITARTRATE IDENTIFICATION USP37–NF32 4346 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Change
C. Identification Tests—General, Tartrate <191>
to:
C. Identification Tests—General, Tartrate <191>: Meets the requirements
AND
Delete subsections:
Sample solution: 1 in 10 solution
Acceptance criteria: Meets the requirements
ZIPRASIDONE HYDROCHLORIDE IMPURITIES/Limit of Tetrahydrofuran USP37–NF32 5219 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Standard solution: Change
0.05 mg/mL of USP Ziprasidone Hydrochloride RS in dimethyl sulfoxide
to:
0.05 mg/mL of tetrahydrofuran in dimethyl sulfoxide
AMIODARONE HYDROCHLORIDE ORGANIC IMPURITIES/Procedure 1/Chromatographic system USP38–NF33 2198 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Adsorbent: Change
0.5-mm layer of chromatographic silica gel and fluorescent indicator with maximum absorbance at 254 nm
to:
Suitable layer of chromatographic silica gel and fluorescent indicator with maximum absorbance at 254 nm
CAFFEINE CITRATE ORAL SOLUTION ASSAY/Procedure USP38–NF33 2521 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 5 of Analysis: Change
Result = (rU/rS) × CS × (Mr1/Mr2) × 100
to:
Result = (rU/rS) × C… Read More
PAROXETINE HYDROCHLORIDE IMPURITIES/Limit of 1-Methyl-4-(p-fluorophenyl)-1,2,3,6-tetrahydropyridine USP38–NF33 4765 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Standard solution: Change
42 mg/mL
to:
42 ng/mL
ESTRADIOL VAGINAL INSERTS PERFORMANCE TESTS/Dissolution <711> USP37–NF32 2866 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 3 of Analysis: Change
Calculate the amount of estradiol (C18H24O2) dissolved:
to:
Record the chromatograms, and measure the responses for the estradiol peak. Construct a calibration curve by plotting the peak response versus concentration of… Read More
CIPROFLOXACIN EXTENDED-RELEASE TABLETS IMPURITIES/Organic Impurities Revision Bulletin (Official October 01, 2014) Online 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 16 of Analysis: Change
Mr2 = molecular weight of ciprofloxacin hydrochloride, 367.81
to:
Mr2 = molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81
AND
Line 14 of the second Calculate statement in Analysis… Read More
PACLITAXEL Related compounds/Test 2 (for Material Labeled as Produced by a Semisynthetic Process) USP37–NF32 4163 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 6 after table in Chromatographic system: Change
the relative standard deviation for replicate injections is not more than 2.0%.
to:
the relative standard deviation for replicate injections is not more than 2.0% for the paclitaxel peak.
TETRACAINE OINTMENT Assay USP37–NF32 4891 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 7 of Procedure: Change
(264.37/300.83)(C)(AU / AS)
to:
(264.36/300.82)(C)(AU / AS)
GLYCERYL BEHENATE ASSAY/Procedure/Chromatographic system Second Supplement to USP37–NF32 7075 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Column: Change
7.0-mm × 60-cm; 5-µm packing L21
[Note—Two 7.0-mm × 30-cm L21 columns
to:
7.5-mm × 60-cm; 5-µm 100-Å packing L21
[Note—Two 7.5-mm × 30-cm L21 columns
BUTABARBITAL SODIUM TABLETS PERFORMANCE TESTS/Uniformity of Dosage Units <905>/Procedure for content uniformity USP38–NF33 2501 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 18 of Analysis: Change
CU = nominal concentration of butabarbital sodium in the Sample solution
to:
CU = nominal concentration of butabarbital sodium in the Sample solution (mg/mL)
ESCITALOPRAM TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 2 USP38–NF33 3364 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 13 of Analysis: Change
Mr2 = molecular weight of escitalopram oxalate, 405.30
to:
Mr2 = molecular weight of escitalopram oxalate, 414.43
AZITHROMYCIN SPECIFIC TESTS/pH <791> USP37–NF32 1886 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Sample solution: Change
2 mg/mL from the Sample stock solution in a mixture of methanol and water (1:1)
to:
2 mg/mL obtained by mixing equal volumes of Sample stock solution and water
CIPROFLOXACIN EXTENDED-RELEASE TABLETS ASSAY/Procedure Revision Bulletin (Official October 01, 2014) Online 30-Jan-2015 1-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33 Line 17 of Analysis: Change
Mr2 = molecular weight of ciprofloxacin hydrochloride, 367.81
to:
Mr2 = molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81