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PDF CSV May 14, 2022 through May 14, 2024 All Errata for USP–NF How to use
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<1467> RESIDUAL SOLVENTS—VERIFICATION OF COMPENDIAL PROCEDURES AND VALIDATION OF ALTERNATIVE PROCEDURES VERIFICATION OF COMPENDIAL PROCEDURES USP43–NF38 8404 1-Dec-2020 NA NA In Limit Procedures: Procedure A and Procedure B/Verification when solvents likely to be present (LTBP) are not known/Specificity: Change
or acetonitrile and cis-dichloroethene
to:
or methylisobutylketone and cis-dichloroethene
<1227> VALIDATION OF MICROBIAL RECOVERY FROM PHARMACOPEIAL ARTICLES VALIDATION OF NEUTRALIZATION METHODS—RECOVERY COMPARISONS Second Supplement to USP42–NF37 9616 1-Dec-2019 NA NA In paragraph 1 in Recovery on Agar Medium: Change
If it is necessary to solubilize the test stample,
to:
If it is necessary to solubilize the test sample,
<852> ATOMIC ABSORPTION SPECTROSCOPY VALIDATION AND VERIFICATION/Precision/Intermediate Precision USP38–NF33 649 1-Dec-2015 USP40–NF35 Second Supplement to USP39–NF34 Line 3: Change
As a minimum, the analytical procedure should be assessed by performing the repeatability test in any of the conditions previously mentioned (totaling 12 measurements).
to:
As a minimum, the analytical procedure should be assessed by performing the repeatability test in… Read More
FLURAZEPAM HYDROCHLORIDE USP REFERENCE STANDARDS 〈11〉 USPNF Online Online 1-Mar-2024 NA NA In USP Flurazepam Related Compound C RS: Change
5-Chloro-2-(2-diethylaminoethyl(amino)-2′-fluorobenzophenone hydrochloride.
to:
5-Chloro-2-(2-diethylaminoethylamino)-2′-fluorobenzophenone hydrochloride.
<467> RESIDUAL SOLVENTS USP REFERENCE STANDARDS <11> USPNF Online Online 1-Sep-2022 NA NA Change
USP Residual Solvent Class 2—Mixture C RS
to:
USP Residual Solvents Class 2—Mixture C RS
<81> ANTIBIOTICS—MICROBIAL ASSAYS Turbidimetric Method USP36–NF31 76 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.
PACLITAXEL INJECTION TITLE USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA Change
Paclit 1axel Injection
to:
Paclitaxel Injection
<661.1> PLASTIC MATERIALS OF CONSTRUCTION TEST METHODS/Tin in Non-Tin-Stabilized Materials USP41–NF36 6403 1-Apr-2018 USP42–NF37 USP42–NF37 Line 3 of Sample solution: Change
If the solution is not colorless, add the sodium sulfate
to:
If the solution is not colorless, add the sodium sulfite
<661.2> PLASTIC PACKAGING SYSTEMS FOR PHARMACEUTICAL USE TEST METHODS/Physicochemical Tests/Water Extraction/Acidity or alkalinity USP39–NF34 506 1-Dec-2016 USP41–NF36 Second Supplement to USP40–NF35 Line 2 of Methyl red TS 2: Change
NMT 0.1 mL of 0.02 N hydrochloric acid
to:
NMT 0.1 mL of 0.02 N sodium hydroxide
<661.1> PLASTIC MATERIALS OF CONSTRUCTION TEST METHODS/Physicochemical Tests/Absorbance USP39–NF34 493 1-Apr-2016 USP40–NF35 USP40–NF35 Line 3 of Plasticized polyvinyl chloride: Delete
Additionally, for nonplasticized polyvinyl chloride materials only, determine the spectrum between 250 and 330 nm in the alcohol sample associated with Solution S6.
<661.1> PLASTIC MATERIALS OF CONSTRUCTION TEST METHODS/Extractions/Table 3 USP39–NF34 493 1-Apr-2016 USP40–NF35 USP40–NF35 Column 4 of S3 row: Change
Extractable metals: Al, Sb, As, Ba, Cd, Co, Ge, Hg, Mn, Ni, Pb, Ti, V, and Zn
to:
Extractable metals: Al, As, Ba, Cd, Co, Hg, Mn, Ni, Pb, Ti, V, and Zn
<661.1> PLASTIC MATERIALS OF CONSTRUCTION TEST METHODS/Extractions/Table 3 USP39–NF34 493 1-Apr-2016 USP40–NF35 USP40–NF35 Line 1 of footnote b: Change
For nonplasticized polyethylene only.
to:
For polyethylene only.
<661.1> PLASTIC MATERIALS OF CONSTRUCTION TEST METHODS USP40–NF35 542 1-Dec-2016 USP41–NF36 Second Supplement to USP40–NF35 Line 1 of Physicochemical Tests/Acidity or Alkalinity/BRP indicator solution: Change
1.0 mg/mL of bromophenol blue,
to:
1.0 mg/mL of bromothymol blue,
AND
Line 3 of Plastic Additives/Polyethylene, Cyclic Olefins, and Polypropylene/Phenolic… Read More
<661.1> PLASTIC MATERIALS OF CONSTRUCTION TEST METHODS USP41–NF36 6403 1-Aug-2018 USP43–NF38 Second Supplement to USP41–NF36 Line 1 of Plastic Additives/Reference solutions/Reference solution I: Change
0.24 mg/mL of USP Plastic Additive 4 RS prepared in the Solvent mixture
to:
0.24 mg/mL of USP Plastic Additive 4 RS prepared in methylene… Read More
<561> ARTICLES OF BOTANICAL ORIGIN TEST FOR AFLATOXINS/Method I USP42–NF37 6701 1-Jun-2019 NA NA In Aflatoxin standard solution: Change
ε = molecular absorptivity
to:
ε = molar absorptivity
AND
in paragraph 2 of Aflatoxin standard solution: Change
transfer an accurate volume of each aflatoxin standard stock solution
to:… Read More
<621> CHROMATOGRAPHY SYSTEM SUITABILITY/Stationary Phase USP35–NF30 258 1-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31 Line 3 of Flow Rate (HPLC): Change
Read More
<621> CHROMATOGRAPHY SYSTEM SUITABILITY USPNF Online Online 1-Dec-2022 NA NA Change
System Repeatability—Assay of an Active Substance or an Excipient
to:
System Repeatability
DESCRIPTION AND SOLUBILITY SUNFLOWER OIL Second Supplement to USP38–NF33 7761 1-Dec-2015 USP40–NF35 Second Supplement to USP39–NF34 Line 5: Change
NF category: Coating agent; emollient; solvent; tablet and/or capsule diluent; vehicle (oleaginous).
to:
NF category: Coating agent; emollient; solvent; diluent; vehicle (oleaginous).
OIL- AND WATER-SOLUBLE VITAMINS WITH MINERALS CAPSULES STRENGTH/Molybdenum, Method 1 Second Supplement to USP36–NF31 6372 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 2 of Standard solutions: Change
2.0
to:
5.0
WATER-SOLUBLE VITAMINS WITH MINERALS CAPSULES STRENGTH/Molybdenum, Method 1 Second Supplement to USP36–NF31 6479 1-Feb-2014 USP38–NF33 Second Supplement to USP37–NF32 Line 2 of Standard solutions: Change
2.0
to:
5.0
VALERIAN TINCTURE STRENGTH/Content of Valerenic Acids Second Supplement to USP36–NF31 6352 1-Dec-2013 USP38–NF33 Second Supplement to USP37–NF32 Line 1 of Acceptance criteria: Change
90.0%–120.0%
to:
NLT 0.015% of valerenic acids, calculated as the sum of hydroxyvalerenic acid, acetoxyvalerenic acid, and valerenic acid
MILK THISTLE CAPSULES STRENGTH/Content of Silymarin USP39–NF34 6765 1-Apr-2017 USP41–NF36 USP41–NF36 Row 2 of Column 2 of Table 1: Change
0
to:
85
AND
Row 2 of Column 3 of Table 1: Change
0
to:
15
MILK THISTLE TABLETS STRENGTH/Content of Silymarin USP39–NF34 6767 1-Apr-2017 USP41–NF36 USP41–NF36 Row 2 of Column 2 of Table 1: Change
0
to:
85
AND
Row 2 of Column 3 of Table 1: Change
0
to:
15
CURCUMINOIDS CAPSULES STRENGTH/Content of Curcuminoids/Chromatographic system USP39–NF34 6583 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 1 of Column: Change
4.6-mm × 20-cm;
to:
4.6-mm × 25-cm;
CURCUMINOIDS TABLETS STRENGTH/Content of Curcuminoids/Chromatographic system USP39–NF34 6585 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 1 of Column: Change
4.6-mm × 20-cm;
to:
4.6-mm × 25-cm;
OIL- AND WATER-SOLUBLE VITAMINS WITH MINERALS ORAL SOLUTION STRENGTH/Chromium Second Supplement to USP36–NF31 6399 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)
EVENING PRIMROSE OIL CAPSULES STRENGTH/Analysis USP40–NF35 6952 1-Jun-2017 USP41–NF36 USP41–NF36 In the first variable definition list: Change
mS = weight of USP Methyl Ester RS in the Standard solution (mg)
to:
mS = weight of the relevant USP Methyl Ester RS in the Standard solution (mg)
OIL- AND WATER-SOLUBLE VITAMINS CAPSULES STRENGTH USP40–NF35 7290 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1 of Vitamin A, Method 1/Sample solution: Change
Sample solution
to:
Sample stock solution
AND
Line 23 of Sample solution: Change
Dilute a volume of this solution
to:
Sample solution: Dilute a volume of the Sample stock… Read More
OIL- AND WATER-SOLUBLE VITAMINS TABLETS STRENGTH USP40–NF35 7318 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1 of Vitamin A, Method 1/Sample solution: Change
Sample solution
to:
Sample stock solution
AND
Line 16 of Sample solution: Change
Dilute a 10-mL volume of this solution
to:
Sample solution: Dilute a 10-mL volume of the Sample… Read More
OIL- AND WATER-SOLUBLE VITAMINS WITH MINERALS CAPSULES STRENGTH USP40–NF35 7336 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1 of Vitamin A, Method 1/Sample solution: Change
Sample solution
to:
Sample stock solution
AND
Line 23 of Vitamin A, Method 1/Sample solution: Change
Dilute a volume of this solution
to:
Sample solution: Dilute a volume of the… Read More
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%
OIL- AND WATER-SOLUBLE VITAMINS WITH MINERALS TABLETS STRENGTH USP40–NF35 7375 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1 of Vitamin A, Method 1/Sample solution: Change
Sample solution
to:
Sample stock solution
AND
Line 16 of Sample solution: Change
Dilute a 10-mL volume of this solution
to:
Sample solution: Dilute a 10-mL volume of the Sample… Read More
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
OIL- AND WATER-SOLUBLE VITAMINS TABLETS STRENGTH USP43–NF38 5419 1-May-2020 NA NA In the variable definition for F in Vitamin E, Method 2/Analysis: Change
1/2 for products labeled to contain all-rac vitamin E sources)
to:
1/2 (for products labeled to contain all-rac vitamin E sources)
AND
In Biotin,… Read More
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
OIL- AND WATER-SOLUBLE VITAMINS WITH MINERALS CHEWABLE GELS STRENGTH USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA In Vitamins B3 (as Niacinamide), B6, and Folic Acid, Method 1/System suitability: Change
[Note—The relative retention times for niacinamide, pyridoxine, and folic acid are about 1.0, 1.6, 2.0, and 3.0 respectively.]
to:
[Note—The relative… Read More
OIL-SOLUBLE VITAMINS CAPSULES STRENGTH USP40–NF35 7248 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1 of Vitamin A, Method 1/Sample solution: Change
Sample solution
to:
Sample stock solution
AND
Line 23 of Sample solution: Change
Dilute a volume of this solution
to:
Sample solution: Dilute a volume of the Sample stock… Read More
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
OIL-SOLUBLE VITAMINS TABLETS STRENGTH USP40–NF35 7258 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1 of Vitamin A, Method 1/Sample solution: Change
Sample solution
to:
Sample stock solution
AND
Line 16 of Sample solution: Change
Dilute a 10-mL volume of this solution
to:
Sample solution: Dilute a 10-mL volume of the Sample… Read More
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
OIL-SOLUBLE VITAMINS WITH MINERALS CAPSULES STRENGTH USP40–NF35 7265 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1 of Vitamin A/Sample solution: Change
Sample solution
to:
Sample stock solution
AND
Line 21 of Sample solution: Change
Further dilute this solution
to:
Sample solution: Dilute the Sample stock solution
AND
Line 2… Read More
OIL- AND WATER-SOLUBLE VITAMINS WITH MINERALS CAPSULES STRENGTH USPNF Online Online 1-Nov-2023 NA NA In Vitamin A, Method 3/Analysis: Change
CS = concentration of retinyl acetate (C23H32O2) from USP Vitamin A RS in the Standard solution (μg/mL)
to:
CS = concentration… Read More
OIL-SOLUBLE VITAMINS WITH MINERALS TABLETS STRENGTH USP40–NF35 7280 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1 of Vitamin A/Sample solution: Change
Sample solution
to:
Sample stock solution
AND
Line 15 of Sample solution: Change
Further dilute this solution
to:
Sample solution: Dilute the Sample stock solution
AND
Line 2… Read More
OIL-SOLUBLE VITAMINS CAPSULES STRENGTH USPNF Online Online 1-Nov-2023 NA NA In Vitamin A, Method 3/Analysis: Change
CS = concentration of retinyl acetate (C23H32O2) from USP Vitamin A RS in the Standard solution (μg/mL)
to:
CS = concentration… Read More
<31> VOLUMETRIC APPARATUS STANDARDS OF ACCURACY First Supplement to USP43–NF38 Online 1-Nov-2020 NA NA In paragraph 3: Change
and then touched against the wall of the receiving vessel to drain the tips.
to:
and then touched against the wall of the receiving vessel to drain the pipet tip.
0.1 M ZINC SULFATE VS STANDARDIZATION USPNF Online Online 1-Dec-2022 NA NA In Standardization with visual end point: Change
M = mL edetate disodium × edetate disodium/mL ZnSO4
to:
M = mL edetate disodium × M edetate disodium/mL ZnSO4
AND
In Standardization with potentiometric end point… Read More
0.1 N Potassium Permanganate VS STANDARDIZATION USPNF Online Online 1-Sep-2022 NA NA In Standardization with potentiometric endpoint: Change
N = g Na2C2O4/mL KMNnO4 solution × 0.06700
to:
N = g Na2C2O4/mL KMnO4 solution × 0.06700
<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 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>)
<661.1> PLASTIC MATERIALS OF CONSTRUCTION SPECIFICATIONS/Polyethylene/Extractable Metals USP39–NF34 493 1-Apr-2016 USP40–NF35 USP40–NF35 Line 1 of Zirconium: Change
1 µg/g.
to:
0.1 µg/g.
<661.1> PLASTIC MATERIALS OF CONSTRUCTION SPECIFICATIONS/Polyethylene Terephthalate and Polyethylene Terephthalate G/Extractable Metals USP39–NF34 493 1-Apr-2016 USP40–NF35 USP40–NF35 Line 1 of Titanium: Change
0.1 µg/g.
to:
1 µg/g.