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PDF CSV October 4, 2022 through October 5, 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
RALTEGRAVIR CHEWABLE TABLETS IMPURITIES/Organic Impurities USP43–NF38 3835 1-May-2020 NA NA In Analysis: Change
Mr1 = molecular weight of raltegravir, 444.44
to:
Mr1 = molecular weight of raltegravir, 444.42
CETIRIZINE HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 915 1-May-2020 NA NA In USP Cetirizine Related Compound A RS: Change
506.98
to:
506.97
OIL-SOLUBLE VITAMINS TABLETS STRENGTH USP43–NF38 5356 1-May-2020 NA NA In Vitamin E, Method 3/Analysis: Change
alpha -ocopheryl acetate
to:
alpha-tocopheryl acetate
DEMECLOCYCLINE HYDROCHLORIDE SPECIFIC TESTS/Loss on Drying USP43–NF38 1248 1-May-2020 NA NA In Analysis: Change
Dry the Sample at 60° for 3 h.
to:
Dry the Sample in a capillary-stoppered bottle in vacuum at 60° for 3 h.
WATER-SOLUBLE VITAMINS WITH MINERALS TABLETS STRENGTH USP43–NF38 5552 1-May-2020 NA NA In the Calculate statement in Niacin or Niacinamide, Pyridoxine Hydrochloride, Riboflavin, and Thiamine, Method 1/Analysis: Delete
, calcium pantothenate (C18H32CaN2O10), and folic acid (C19… Read More
EPINEPHRINE ADDITIONAL REQUIREMENTS USP43–NF38 Online 1-May-2020 NA NA This erratum applies to the USP-NF ONLINE platform only.
In USP Reference Standards <11>: Add
USP Racepinephrine Hydrochloride RS
SODIUM METABISULFITE IMPURITIES/Limit of Chloride USP43–NF38 6020 1-May-2020 NA NA In Analysis: Change
(see Nephelometry, Turbidimetry, and Visual Comparison <855>).
to:
(see Visual Comparison <630>).
MEXILETINE HYDROCHLORIDE CHEMICAL INFORMATION USP43–NF38 2943 1-May-2020 NA NA Change
[5370-01-04].
to:
[5370-01-4].
<856> NEAR-INFRARED SPECTROSCOPY 4. VALIDATION AND VERIFICATION USP43–NF38 7161 1-May-2020 NA NA In 4.1 Validation/4.1.1 Accuracy/Validation criteria/Criteria 1: Change
Suitable agreement between SEP
to:
Suitable agreement between the standard error of prediction (SEP)
PROPRANOLOL HYDROCHLORIDE IMPURITIES/Organic Impurities USP43–NF38 3746 1-May-2020 NA NA In System suitability/Suitability requirements/Relative standard deviation: Change
NMT 5.0,
to:
NMT 5.0%,
RALTEGRAVIR CHEWABLE TABLETS ASSAY/Procedure USP43–NF38 3835 1-May-2020 NA NA In Analysis: Change
Mr1 = molecular weight of raltegravir, 444.44
to:
Mr1 = molecular weight of raltegravir, 444.42
VITAMIN E ASSAY/Alpha Tocopheryl Acid Succinate USP43–NF38 4637 1-May-2020 NA NA In Sample solution: Change
tocoopheryl
to:
tocopheryl
REPOSITORY CORTICOTROPIN INJECTION ADDITIONAL REQUIREMENTS USP43–NF38 1174 1-May-2020 NA NA In USP Reference Standards <11>: Add
USP Ascorbic Acid RS
OIL- AND WATER-SOLUBLE VITAMINS WITH MINERALS TABLETS STRENGTH USP43–NF38 5476 1-May-2020 NA NA In the Calculate statement in Niacin or Niacinamide, Pyridoxine Hydrochloride, Riboflavin, and Thiamine, Method 1/Analysis: Delete
, calcium pantothenate (C18H32CaN2O10), and folic acid (C19… Read More
EPINEPHRINE IMPURITIES/Organic Impurities USP43–NF38 1645 1-May-2020 NA NA In the third calculation in the Analysis: Change
CU = concentration of Epinephrine in the Sample solution (mg/mL)
to:
CU = concentration of Epinephrine in the Sample solution (µg/mL)
HEXYLENE GLYCOL IMPURITIES/Organic Impurities USP43–NF38 5814 1-May-2020 NA NA In Any other individual impurity/Relative Response Factor in Table 2: Change

to:
1.0
LOPERAMIDE HYDROCHLORIDE IMPURITIES/Organic Impurities USP43–NF38 2658 1-May-2020 NA NA In System suitability/Suitability requirements/Peak-to-valley ratio: Change
NLT 1.5 for loperamide related compounds G and H; NLT 1.5 for loperamide related compounds E and A, System suitability solution
to:
NLT 1.5 for… Read More
0.02 M EDETATE DISODIUM VS REAGENTS AND REFERENCE TABLES/Solutions USP43–NF38 6240 1-May-2020 NA NA Change
0.7444 g
to:
7.444 g
POLYVINYL ALCOHOL IDENTIFICATION/A. USP43–NF38 3593 1-May-2020 NA NA Change
Infrared Absorption <197K>
to:
Spectroscopic Identification Tests <197>, Infrared Spectroscopy: 197K
RALTEGRAVIR TABLETS PERFORMANCE TESTS/Dissolution <711> USP43–NF38 3834 1-May-2020 NA NA In Analysis: Change
Mr1 = molecular weight of raltegravir, 444.44
to:
Mr1 = molecular weight of raltegravir, 444.42
SACCHARIN SODIUM SPECIFIC TESTS/Readily Carbonizable Substances Test <271> USP43–NF38 3965 1-May-2020 NA NA In Matching fluid A: Change
ferric chloride TS,
to:
ferric chloride CS,
BUDESONIDE IMPURITIES/Organic Impurities USP43–NF38 604 1-May-2020 NA NA In footnote k in Table 2: Change
16α,17-[Butylidenebis(oxy)]-11β,21-dihydroxypregna-1,4-diene-3,20-dione-21-acetate.
to:
16α,17-[Butylidenebis(oxy)]-11β-hydroxypregna-1,4-diene-3,20-dione-21-yl acetate.
OIL-SOLUBLE VITAMINS TABLETS ADDITIONAL REQUIREMENTS/Labeling USP43–NF38 5356 1-May-2020 NA NA In footnote 1: Change
-alpha-tocopheryl
to:
all-rac-alpha-tocopheryl
AND
Change
USP Vitamin E unit
to:
USP Vitamin E Unit
AND
Change
2R-alphatocopherol
to:
2R-alpha-tocopherol
DEXAMETHASONE ACETATE Chromatographic purity USP43–NF38 1290 1-May-2020 NA NA Change
Format buffer
to:
Formate buffer
CAPRYLIC ACID ASSAY/Procedure/Chromatographic system USP43–NF38 5664 1-May-2020 NA NA In Column: Change
30-cm
to:
30-m
LEUCOVORIN CALCIUM FOR INJECTION ASSAY/Procedure/Chromatographic system USP43–NF38 2569 1-May-2020 NA NA Delete
Run time: 2 times the retention time of the leucovorin peak
SUCROSE PALMITATE IMPURITIES/Inorganic Impurities USP43–NF38 6078 1-May-2020 NA NA In Fats and Fixed Oils, Acid Value <401>: Change
NMT 6.0%,
to:
NMT 6.0,
NIACIN IDENTIFICATION/B. USP43–NF38 3138 1-May-2020 NA NA Change
Ultraviolet Absorption <197U>
to:
Spectroscopic Identification Tests <197>, Ultraviolet-Visible Spectroscopy: 197U
<1125> NUCLEIC ACID-BASED TECHNIQUES -- GENERAL APPENDICES USP43–NF38 7865 1-May-2020 NA NA In Appendix 2: Delete the Row for
dNTP dinucleotide triphosphate
RALTEGRAVIR TABLETS DEFINITION USP43–NF38 3834 1-May-2020 NA NA Change
(C20H20FN6O5)
to:
(C20H21FN6O5)
RALTEGRAVIR CHEWABLE TABLETS PERFORMANCE TESTS/Dissolution <711> USP43–NF38 3835 1-May-2020 NA NA In Analysis: Change
Mr1 = molecular weight of raltegravir, 444.44
to:
Mr1 = molecular weight of raltegravir, 444.42
ALOSETRON HYDROCHLORIDE IMPURITIES/Organic Impurities USP43–NF38 141 1-May-2020 NA NA In System suitability/Suitability requirements/Resolution: Change
NLT 7
to:
NLT 3
CALCIUM AND VITAMIN D WITH MINERALS TABLETS STRENGTH USP43–NF38 4845 1-May-2020 NA NA In Calcium, Copper, Magnesium, Manganese, and Zinc, Method 2/Acceptance criteria: Change
NLT 90.0%–125.0%
to:
90.0%–125.0%
DAPSONE TABLETS IDENTIFICATION/B. USP43–NF38 1241 1-May-2020 NA NA Change
Ultraviolet Absorption <197U>
to:
Spectroscopic Identification Tests <197>, Ultraviolet-Visible Spectroscopy: 197U
WATER-SOLUBLE VITAMINS TABLETS STRENGTH USP43–NF38 5512 1-May-2020 NA NA In Biotin, Method 3/Solid-phase extraction: Change
anion-xchange
to:
anion-exchange
AND
In the Calculate statement in Niacin or Niacinamide, Pyridoxine Hydrochloride, Riboflavin, and Thiamine, Method 1/Analysis: Delete
,… Read More
EPINEPHRINE IMPURITIES/Enantiomeric Purity USP43–NF38 Online 1-May-2020 NA NA This erratum applies to the USP-NF ONLINE platform only.
In System suitability solution: Change
0.03 mg/mL of in Mobile phase
to:
0.03 mg/mL of USP Racepinephrine Hydrochloride RS in Mobile phase
POLYOXYL 35 CASTOR OIL IDENTIFICATION/C. Identity by Fatty Acid Composition USP43–NF38 5956 1-May-2020 NA NA In System suitability/Suitability requirements/Relative standard deviation: Change
linoeate
to:
linoleate
MENADIONE ASSAY/Procedure USP43–NF38 2780 1-May-2020 NA NA In Endpoint detection: Change
Potentiometric
to:
Visual
<191> IDENTIFICATION TESTS—GENERAL CHEMICAL IDENTIFICATION TESTS USP43–NF38 6587 1-Aug-2020 NA NA In Bicarbonate/B.: Change
(1:20)
to:
(1 in 20)
AND
In Borate/A.: Change
(1:50):
to:
(1 in 50):
AND
In Calcium/A.: Change
(1:20)
to:
(1 in 20)
AND
In Carbonate/B.:… Read More
PROPOFOL IMPURITIES/Organic Impurities, Procedure 2 USP43–NF38 3739 1-May-2020 NA NA In Table 3: Delete
Propofol related compound Bb 0.8 1.0 0.05
AND
Change
Propofol related compound Ac
to:
Propofol related compound Ab
AND
Change
b2,6-Diisopropylbenzoquinone.
Read More
RALTEGRAVIR TABLETS IMPURITIES/Organic Impurities USP43–NF38 3834 1-May-2020 NA NA In Analysis: Change
Mr1 = molecular weight of raltegravir, 444.44
to:
Mr1 = molecular weight of raltegravir, 444.42
VITAMIN A TABLETS ASSAY/Procedure 2 USP43–NF38 4635 1-May-2020 NA NA In the variable definition list in Analysis: Change
Sample solution 1
to:
Sample solution
ITRACONAZOLE CAPSULES PERFORMANCE TESTS/Dissolution <711>/Test 1 Revision Bulletin (Official August 01, 2019) Online 1-Apr-2020 NA NA In System suitability/Suitability requirements/Relative standard deviation: Change
NMT 2.0% for 5 replicate injections
to:
NMT 2.0% for 5 replicates
ANTITHROMBIN III HUMAN SPECIFIC TESTS USP42–NF37 350 1-Apr-2020 NA NA In Pyrogen Test <151>: Change
USP Antithrombin III Units
to:
Antithrombin III IU
ANTITHROMBIN III HUMAN ADDITIONAL REQUIREMENTS USP42–NF37 350 1-Apr-2020 NA NA In Labeling: Change
USP Antithrombin III Units.
to:
Antithrombin III IU.
CALCIUM ACETATE CAPSULES PERFORMANCE TESTS/Dissolution <711> Revision Bulletin (Official January 01, 2020) Online 1-Mar-2020 NA NA In Test 1/Analysis: Change
dissolved at time point (i):
Resulti = (rU/rS) × CS × V × D × (1/L) × 100
to:
dissolved:
Read More
FLUNIXIN MEGLUMINE INJECTION IMPURITIES/Organic Impurities USP42–NF37 1890 1-Mar-2020 NA NA In Sensitivity solution: Change
in Diluent from the Standard solution
to:
in Diluent
LITHIUM CARBONATE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 1 USP42–NF37 2598 1-Mar-2020 NA NA In Analysis: Change
V = volume of Medium, 900 mL
to:
V = volume of Medium, 800 mL
DICLOXACILLIN SODIUM CAPSULES PERFORMANCE TESTS USP42–NF37 1330 1-Mar-2020 NA NA In Dissolution <711>: Change
Sample solution: Sample per the chapter. Dilute with Medium to a concentration that is similar to the Standard solution.
Tolerances: NLT 75% (Q) of the labeled amount of… Read More
ALFADEX CHEMICAL INFORMATION USP42–NF37 5561 1-Feb-2020 NA NA Change
972.84
to:
972.85