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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 Official Date Target Errata Print Publication Target Online Fix Publication Description
<1160> PHARMACEUTICAL CALCULATIONS IN PHARMACY PRACTICE 19. MEAN KINETIC TEMPERATURE/19.2 MKT Equation USP42–NF37 7831 1-May-2019 NA NA In the variable definition list: Change
Tn = value for the total number of storage temperatures recorded during the observation period temperature recorded during the nth time period, e.g., nth week
to:
Tn Read More
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS ASSAY/Procedure/Chromatographic system First Supplement to USP42–NF37 Online 1-May-2019 NA NA In Column: Change
4.6-mm × 15-cm; 5-µm packing L7. [Note—Conditioning of the Column with Solution A and Solution B (90:10) (ERR 1-Mar-2019) for about 30 min is recommended prior to use.]
to:
4.6-mm × 15-cm… Read More
IMIPRAMINE PAMOATE CAPSULES IMPURITIES/Organic Impurities USP42–NF37 Online 1-May-2019 NA NA In Solution A: Change
Chromatographic acetonitrile
to:
Acetonitrile
AND
In Solution B: Change
chromatographic acetonitrile
to:
acetonitrile
MORPHINE SULFATE EXTENDED-RELEASE CAPSULES IMPURITIES/Organic Impurities Revision Bulletin (Official November 01, 2018) Online 1-May-2019 NA NA In Row 4 of Column 1 of Table 5: Change
Morphine related compound Bb
to:
Morphine related compound B (anhydrous)b
HYPROMELLOSE PHTHALATE IMPURITIES/Chloride and Sulfate <221>, Chloride Harmonization (Official May 01, 2019) Online 1-May-2019 NA NA In Analysis: Change
Add 1 mL of silver nitrate TS to the Standard solution and then add a 50-mL portion of the Sample solution. Mix and allow to stand for 5 min protected from direct sunlight. Compare the turbidity of the… Read More
<855> NEPHELOMETRY AND TURBIDIMETRY 5. FORMAZIN TURBIDITY STANDARDS USP42–NF37 7059 1-May-2019 NA NA In paragraph 1: Change
IUPAC Compendium of Chemical Technology,
to:
IUPAC Compendium of Chemical Terminology,
FELODIPINE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 2 USP42–NF37 1787 1-May-2019 NA NA In the second variable definition list in Analysis: Change
VS = volume of the Sample solution withdrawn at each time point, i
to:
VS = volume of the Sample solution withdrawn at… Read More
LEVALBUTEROL INHALATION SOLUTION IMPURITIES/Organic Impurities USP42–NF37 2520 1-May-2019 NA NA In Row 3 of Table 3: Change
Levalbuterol —  — —
to:
Levalbuterol 1.0 — —
THALIDOMIDE Assay USP42–NF37 4281 1-May-2019 NA NA In Chromatographic system: Change
and the relative standard deviation for replicate injections is not more than 1.0%.
to:
and the relative standard deviation for the response ratio of thalidomide to phenacetin is not more than 1.0%.
REAGENTS AND REFERENCE TABLES REAGENT SPECIFICATIONS USP42–NF37 6104 1-May-2019 NA NA In Ferric Nitrate: Change
[10421-48-4].
to:
[7782-61-8].
PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711> Revision Bulletin (Official March 01, 2019) Online 1-May-2019 NA NA In the Figure 1 caption: Change
(see Drug Release <724>, Figure 4c)
to:
(see Drug Release <724>, Figure 5c)
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS PERFORMANCE TESTS/Dissolution <711> First Supplement to USP42–NF37 Online 1-May-2019 NA NA In Row 2 of Column 3 of Table 4: Change
0.014/0.028▲2S (USP41)
to:
0.014
AND
In Row 3 of Column 3 of Table 4: Change
0.014
to:
0.014/0.028
AND
In Chromatographic… Read More
LEVALBUTEROL HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 2518 1-May-2019 NA NA In USP Levalbuterol Related Compound D RS: Change
5-{2-[(1,1-Dimethylethyl)amino]-1-hydroxyethyl}-2-hydroxy-benzaldehyde.
C13H19NO3 237.29
[NOTE—This may be available as the sulfate salt (2:1).]▲ (USP… Read More
MORPHINE SULFATE EXTENDED-RELEASE CAPSULES ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Revision Bulletin (Official November 01, 2018) Online 1-May-2019 NA NA In USP Morphine Related Compound B RS: Change
2,2'-Bimorphine.
C34H36N2O6 568.66
to:
2,2'-Bimorphine trihydrate.
C34H36N2O6 ∙ 3H2O 622.72
INOSITOL IMPURITIES/Limit of Lead USP42–NF37 5776 1-May-2019 NA NA In Standard lead solution: Delete
A comparison solution prepared on the basis of 100 µL of the Standard lead solution per g of substance being tested contains the equivalent of 1 part of lead per million parts of substance being tested.
<1160> PHARMACEUTICAL CALCULATIONS IN PHARMACY PRACTICE 10. ALLIGATION ALTERNATE AND ALGEBRA METHODS FOR COMBINING MULTIPLE STRENGTHS OF THE SAME ACTIVE PHARMACEUTICAL INGREDIENT USP42–NF37 7831 1-May-2019 NA NA In 10.2 Algebra Method/10.2.1 Calculating by using the algebra method/Examples—Algebra method:
In example 2, in equations 1, 2, 3, and 4 in all instances: Change
Cs
to:
Qs
AND
In example… Read More
ATORVASTATIN CALCIUM ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 410 1-May-2019 NA NA In USP Atorvastatin Related Compound A RS: Change
Desfluoro impurity, or (3R,5R)-7-[3-(phenylcarbamoyl)-2-isopropyl-4,5-diphenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
to:
Calcium (3R,5R)-7-[2-… Read More
IMIPRAMINE PAMOATE CAPSULES ASSAY/Procedure USP42–NF37 Online 1-May-2019 NA NA In Solution A and Solution B and Diluent: Change
Chromatographic acetonitrile
to:
Acetonitrile
LEVALBUTEROL INHALATION SOLUTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 2520 1-May-2019 NA NA In USP Levalbuterol Related Compound D RS: Change
5-[2-{(1,1-Dimethylethyl)amino}-1-hydroxyethyl]-2-hydroxy-benzaldehyde;
Also known as 5-[2-{(1,1-Dimethylethyl)amino}methyl]-4-hydroxy-3-(methoxymethyl)-benzenemethanol.
C13H… Read More
TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 1/Instrumental conditions USP42–NF37 4409 1-May-2019 NA NA In Cell: Change
5 cm
to:
5 mm
<855> NEPHELOMETRY AND TURBIDIMETRY 4. INSTRUMENTATION USP42–NF37 7059 1-May-2019 NA NA In paragraph 2: Change
silicone diodes
to:
silicon diodes
CLONIDINE TRANSDERMAL SYSTEM PERFORMANCE TESTS/Drug Release <724>/Test 1 USP42–NF37 1084 1-May-2019 NA NA Apparatus 7: Change
(see Figure 4a).
to:
(see Figure 5a).
METAXALONE IDENTIFICATION/B. USP41–NF36 2611 1-Apr-2019 NA NA Change
The retention time of the major peak of the Sample solution corresponds to that of the Sample solution, as obtained in the Assay.
to:
The retention time of the major peak of the Sample solution corresponds to that of… Read More
ISOPHANE INSULIN HUMAN SUSPENSION ASSAY/Procedure Interim Revision Announcement (Official January 01, 2019) Online 1-Apr-2019 NA NA In Standard solution: Change
USP Insulin Beef RS
to:
USP Insulin Human RS
SCOPOLAMINE HYDROBROMIDE IDENTIFICATION/B. First Supplement to USP41–NF36 8420 1-Apr-2019 NA NA In Sample solution: Change
50 mg/mL of alcohol
to:
50 mg/mL in water
PREDNISOLONE SODIUM PHOSPHATE Related compounds USP41–NF36 3416 1-Apr-2019 NA NA In Table 1: Add
Prednisolone sodium phosphate 1.00 — —
MERCAPTOPURINE IMPURITIES/Organic Impurities USP41–NF36 2587 1-Apr-2019 NA NA Change
Sample solution: 0.12 mg/mL of Mercaptopurine in Solution A. [NOTE—Inject the Sample solution within 1 h of preparation.]
to:
Sample stock solution: 0.5 mg/mL of mercaptopurine in a mixture of methanol and Read More
BUMETANIDE TABLETS ASSAY/Procedure Second Supplement to USP41–NF36 Online 1-Apr-2019 NA NA In Sample solution: Change
Nominally 0.05 mg/mL of bumetanide prepared as follows.
to:
Nominally 125 µg/mL of bumetanide prepared as follows.
RUTIN CHEMICAL INFORMATION USP41–NF36 4841 1-Apr-2019 NA NA Change
3-Rhamnoglucoside of 5,7,3',4'-tetrahydroxyflavonol;
2-(3,4-Dihydroxyphenyl)-5,7-dihydroxy-4H-chromen-4-one-3-yl 6-O-α-L-rhamnopyranosyl-β-D-glucoside [250249-75-3].
to:
3-Rhamnoglucoside of 5,7,3',4'-tetrahydroxyflavonol… Read More
ARGATROBAN CHEMICAL INFORMATION USP41–NF36 346 1-Mar-2019 NA NA See https://www.uspnf.com/sites/default/files/usp_pdf/EN/february_2019_errata_image1.pdf for correction
CALCIUM SILICATE IMPURITIES/Limit of Lead USP41–NF36 5240 1-Mar-2019 NA NA In Lead standard solution: Change
1000 mg of lead/mL4
to:
1000 mg of lead/L4
CARBINOXAMINE MALEATE TABLETS IMPURITIES/Organic Impurities Second Supplement to USP41–NF36 8788 1-Mar-2019 NA NA In the Standard stock solution: Change
USP Carbinoxamine Maleate RS free base)
to:
carbinoxamine)
AND
In the Standard solution: Change
USP Carbinoxamine Maleate RS free base)
to:
carbinoxamine)
AND
In the Analysis… Read More
REAGENTS Reagent Specifications/7,8-Dihydrofolic Acid Second Supplement to USP41–NF36 9052 1-Mar-2019 NA NA Change
(L-Glutamic Acid, N-[4-[[(2-Amino-3,4,7,8-tetrahydro-4-pteridinyl)methyl]amino]benzoyl]-),
to:
(L-Glutamic Acid, N-[4-[[(2-Amino-3,4,7,8-tetrahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-),
METHYLDOPA SPECIFIC TESTS/Optical Rotation <781S> USP41–NF36 2666 1-Mar-2019 NA NA In the Sample solution: Change
aluminum chloride
to:
aluminum chloride hexahydrate
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS ASSAY/Procedure/Chromatographic system Second Supplement to USP41–NF36 8781 1-Mar-2019 NA NA In Column: Change
[Note—Conditioning of the Column with Solution A and Solution B (80:20)
to:
[Note—Conditioning of the Column with Solution A and Solution B (90:10)
MESNA TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP41–NF36 8906 1-Mar-2019 NA NA In USP Mesna Related Compound A RS: Change
2-(Acetylthio)ethane-1-sulfonic acid.
C4H8O4S2 184.22
to:
2-(Acetylthio)ethane-1-sulfonic acid, potassium salt, crystal adduct with potassium chloride.
C4… Read More
DEXMEDETOMIDINE HYDROCHLORIDE CHEMICAL INFORMATION USP41–NF36 Online 1-Mar-2019 NA NA This erratum applies to the USP-NF ONLINE platform only.
See https://www.uspnf.com/sites/default/files/usp_pdf/EN/february_2019_errata_image1.pdf for correction
REAGENTS Solutions/Volumetric Solutions/0.01 N Sodium Hydroxide VS USP41–NF36 5770 1-Mar-2019 NA NA See https://www.uspnf.com/sites/default/files/usp_pdf/EN/february_2019_errata_image1.pdf for correction
FLUDROCORTISONE ACETATE TABLETS IMPURITIES/Organic Impurities/Table 1 Second Supplement to USP41–NF36 8843 1-Mar-2019 NA NA In footnote a: Change
9-Fluoro-11β,17,21-trihydroxypregn-4-ene-3,20-dione 21-acetate.
to:
9-Fluoro-11β,17,21-trihydroxypregn-4-ene-3,20-dione.
<1010> ANALYTICAL DATA—INTERPRETATION AND TREATMENT MEASUREMENT PRINCIPLES AND VARIATION USP42–NF37 7129 1-Mar-2019 NA NA See https://www.uspnf.com/sites/default/files/usp_pdf/EN/february_2019_errata_image1.pdf for correction
OXANDROLONE Related compounds USP41–NF36 3072 1-Mar-2019 NA NA In footnote 4 of the second table: Change
Methyl-(1,17β-dihydroxy-17α-methyl-1,3-seco-2-nor-5α-androstane-3-oate.
to:
Methyl 1,17β-dihydroxy-17α-methyl-1,3-seco-2-nor-5α-androstan-3-oate.
CARBINOXAMINE MALEATE IMPURITIES/Organic Impurities Second Supplement to USP41–NF36 8786 1-Mar-2019 NA NA In Standard stock solution: Change
(equivalent to 0.05 mg/mL of USP Carbinoxamine Maleate RS free base) and 0.05 mg/mL each of USP Carbinoxamine Related Compound A RS, USP Carbinoxamine Related Compound B RS, and USP Carbinoxamine Related Compound C RS… Read More
PRAZOSIN HYDROCHLORIDE COMPOUNDED ORAL SUSPENSION ASSAY/Procedure Second Supplement to USP41–NF36 8945 1-Mar-2019 NA NA In the Mobile phase: Change
tetramethylammonium hydrochloride
to:
tetramethylammonium hydroxide
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS ASSAY/Procedure USP41–NF36 1358 1-Mar-2019 NA NA In Buffer: Change
0.5 g/L of citric acid and 0.4 g/L of dibasic sodium phosphate in water
to:
0.5 g/L of anhydrous citric acid and 0.4 g/L of anhydrous dibasic sodium phosphate in water
AMITRIPTYLINE HYDROCHLORIDE TABLETS IMPURITIES/Organic Impurities Second Supplement to USP41–NF36 8759 1-Mar-2019 NA NA In Analysis: Change
rU = peak response of amitriptyline related compound A, amitriptyline related compound B, or nortriptyline hydrochloride from the Sample solution
rS = peak response of amitriptyline related… Read More
MESNA ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP41–NF36 8904 1-Mar-2019 NA NA In USP Mesna Related Compound A RS: Change
2-(Acetylthio)ethane-1-sulfonic acid.
C4H8O4S2 184.22
to:
2-(Acetylthio)ethane-1-sulfonic acid, potassium salt, crystal adduct with potassium chloride.
C4… Read More
SALMETEROL INHALATION POWDER PERFORMANCE TESTS First Supplement to USP41–NF36 Online 1-Feb-2019 NA NA In the definition list in Particle Size Distribution by Cascade Impaction/Analysis: Change
Mr1 = molecular weight of salmeterol free base, 415.75
to:
Mr1 = molecular weight of salmeterol… Read More
SALIX SPECIES BARK POWDER INTRODUCTION USP42–NF37 5189 1-Feb-2019 NA NA Delete
(This monograph is postponed indefinitely.)
LEFLUNOMIDE IMPURITIES/Organic Impurities/Procedure 2 USP41–NF36 2353 1-Feb-2019 NA NA Change
Standard solution: 0.5 µg/mL of USP Leflunomide RS, from the Standard solution in Mobile phase
to:
Standard stock solution: Proceed as directed in the Standard solution in the Assay.
Read More
SALIX SPECIES BARK DRY EXTRACT INTRODUCTION USP42–NF37 5187 1-Feb-2019 NA NA Delete
(This monograph is postponed indefinitely.)