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CSV April 26, 2016 through April 26, 2018 See all Errata for USP–NF How to use
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Monograph Title Section Source Publication Page Number Errata Official Date Sort ascending Target Errata Print Publication Target Online Fix Publication Description
SALMETEROL INHALATION POWDER ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP40–NF35 6096 1-Apr-2018 USP42–NF37 USP42–NF37 Line 2 of USP Salmeterol Related Compound H RS: Change
1-Hydroxy-4-[2-hydroxy-5-(1-hydroxy-2-{[6-(4-phenylbutoxy)hexyl]amino}ethyl)benzyl]-2-naphthoic acid.
C36H43NO6 585.73
to:
1-Hydroxy-4-[2-hydroxy-5-(1-… Read More
PERINDOPRIL ERBUMINE IMPURITIES/Limit of Perindopril Related Compound I/System suitability USP40–NF35 5644 1-Apr-2018 USP42–NF37 USP42–NF37 Line 3: Add
[Note—The relative retention times for perindopril and perindopril related compound I are 1.0 and 1.6, respectively.]
FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP40–NF35 4309 1-Apr-2018 USP42–NF37 USP42–NF37 Line 2 of USP Salmeterol Related Compound H RS: Change
1-Hydroxy-4-[2-hydroxy-5-(1-hydroxy-2-{[6-(4-phenylbutoxy)hexyl]amino}ethyl)benzyl]-2-naphthoic acid.
C36H43NO6 585.73
to:
1-Hydroxy-4-[2-hydroxy-5-(1-… Read More
<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
PIPERACILLIN AND TAZOBACTAM FOR INJECTION IMPURITIES/Organic Impurities, Procedure 2/Table 3 USP40–NF35 5728 1-Mar-2018 USP42–NF37 Second Supplement to USP41–NF36 Footnote m: Change
(2S,5R,6R)-Ethyl 6-((R)-2-{(2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxopiperazine-1-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxamido}-2-phenylacetamido)-3,3-dimethyl-7-… Read More
PAROXETINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> First Supplement to USP40–NF35 ONLINE 1-Mar-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of USP Paroxetine Related Compound F RS: Change
trans(−)-1-Methyl-3-[1,3-benzodioxol-5-yloxy)methyl]-4-(fluorophenyl)piperidine.
to:
(3S,4R)-3-[(Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)-1-methylpiperidine.
NOREPINEPHRINE BITARTRATE IDENTIFICATION/B. Procedure USP40–NF35 5380 1-Mar-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of Analysis: Change
Add 1 drop of ferric chloride TS.
to:
Add 1 drop of ferric chloride TS to 2 mL of Sample solution.
NOREPINEPHRINE BITARTRATE ASSAY/Procedure USP40–NF35 5380 1-Mar-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of Sample solution: Change
25 mg/mL of Norepinephrine Bitartrate in glacial acetic acid. If necessary warm slightly to effect solution.
to:
Dissolve 500 mg of Norepinephrine Bitartrate in 20 mL of glacial acetic acid, warming slightly if necessary to… Read More
CHLORHEXIDINE GLUCONATE ORAL RINSE Identification USP40–NF35 3367 1-Mar-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of C: Change
Undiluted Oral Rinse used as the test solution meets the requirements for Identification test B under Calcium Gluconate, except that a Standard solution containing about 0.6 mg of USP Potassium Gluconate RS per mL is used and 15 μL… Read More
AMLODIPINE AND ATORVASTATIN TABLETS ASSAY/Procedure First Supplement to USP41–NF36 8270 1-Mar-2018 USP42–NF37 Second Supplement to USP41–NF36 In the variable definition list of the second equation in Analysis: Change
Mr2 = molecular weight of atorvastatin calcium, 1209.39
to:
Mr2 = molecular weight of atorvastatin calcium, 1155.34
AMLODIPINE AND ATORVASTATIN TABLETS PERFORMANCE TESTS/Dissolution <711> First Supplement to USP41–NF36 8270 1-Mar-2018 USP42–NF37 Second Supplement to USP41–NF36 In the variable definition list of the second equation in Analysis: Change
Mr2 = molecular weight of atorvastatin calcium, 1209.39
to:
Mr2 = molecular weight of atorvastatin calcium, 1155.34
AMLODIPINE AND ATORVASTATIN TABLETS IMPURITIES/Organic Impurities Related to Atorvastatin First Supplement to USP41–NF36 8270 1-Mar-2018 USP42–NF37 Second Supplement to USP41–NF36 In the variable definition list in Analysis: Change
Mr2 = molecular weight of atorvastatin calcium, 1209.39
to:
Mr2 = molecular weight of atorvastatin calcium, 1155.34
<1210> STATISTICAL TOOLS FOR PROCEDURE VALIDATION 3. ACCURACY AND PRECISION/3.1 Methods for Estimating Accuracy and Precision USP41–NF36 7622 1-Mar-2018 USP42–NF37 Second Supplement to USP41–NF36 Paragraph 4: Change
For example, with ɑ = 0.05 and n = 9, t0.95:8 = 1.860 provides a 100(1− 2 × 1.05)%
to:
For example, with ɑ = 0.05 and n = 9, t0.95:8 = 1.860 provides a 100(1 − 2 × 0.05)%
<601> INHALATION AND NASAL DRUG PRODUCTS: AEROSOLS, SPRAYS, AND POWDERS—PERFORMANCE QUALITY TESTS C. AERODYNAMIC SIZE DISTRIBUTION—INHALATION AEROSOLS, SPRAYS, AND POWDERS USP41–NF36 6327 1-Mar-2018 USP42–NF37 Second Supplement to USP41–NF36 Figure 6: Change
Boquilla del Inhalador
to:
Inhaler Mouthpiece
AND
Change
Tubo de Admisión
to:
Induction Port
AND
Change
Cono de Ingreso
to:
Entrance Cone
<81> ANTIBIOTICS—MICROBIAL ASSAYS CALCULATIONS/Turbidimetric Assay/Sample Data USP40–NF35 143 1-Mar-2018 USP42–NF37 Second Supplement to USP41–NF36 Second equation in Step 1: Change
0.0125 =
to:
0.0062 =
AND
Third equation in Step 1: Change
0.0325 =
to:
0.0322 =
REAGENTS REAGENT SPECIFICATIONS USP41–NF36 5724 1-Mar-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of 9Z-Retinoic Acid: Change
Acidalitretinoin),
to:
Alitretinoin),
TIMOLOL MALEATE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP40–NF35 6481 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 3 of USP Timolol Related Compound D RS: Change
C6H9N7O4S
to:
C6H9N3O2S
TIMOLOL MALEATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> First Supplement to USP40–NF35 8416 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of USP Timolol Related Compound A RS: Change
(R)-1-(tert-Butylamino)-3-(4-morpholino-1,2,5-thiadiazol-3-yloxy)propan-2-ol.
C13H24N4O3S 316.42
to:
(R)-1-(tert-Butylamino)-3-(4-… Read More
QUETIAPINE EXTENDED-RELEASE TABLETS IMPURITIES/Organic Impurities Revision Bulletin (Official November 01, 2017) ONLINE 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Footnote a of Table 5: Change
total impurities.
to:
total degradation products.
AND
Footnote b: Change
total impurities.
to:
total degradation products.
PHENYTOIN ORAL SUSPENSION PERFORMANCE TESTS/Dissolution <711> USP41–NF36 3286 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 In the Analysis: Change
CS = concentration of USP Phenytoin RS in the Standard solution
to:
CS = concentration of USP Phenytoin RS in the Standard solution (mg/mL)
NIACIN EXTENDED-RELEASE TABLETS ASSAY/Procedure Revision Bulletin (Official January 01, 2018) ONLINE 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 3 of System suitability: Change
Table 4
to:
Table 13
NEVIRAPINE TABLETS IMPURITIES/Organic Impurities USP40–NF35 5333 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of Standard solution: Change
0.125 μg/mL of USP Nevirapine Anhydrous RS from Standard stock solution A in Diluent
to:
0.125 μg/mL of USP Nevirapine Anhydrous RS in Diluent
LIDOCAINE HYDROCHLORIDE AND DEXTROSE INJECTION Identification USP40–NF35 4852 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of B: Change
It responds to the Identification test under Dextrose.
to:
Add a few drops of a solution (1 in 20) to 5 mL of hot alkaline cupric tartrate TS. A copious red precipitate of cuprous oxide is formed.
ESZOPICLONE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Revision Bulletin (Official August 01, 2017) ONLINE 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of USP Eszopiclone Related Compound A RS: Change
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide.
C17H17ClN6O4 404.81
to:
[Note… Read More
ESZOPICLONE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP40–NF35 4090 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of USP Eszopiclone Related Compound A RS: Change
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide.
C17H17ClN6O4 404.81
to:
[Note… Read More
ECHINACEA SPECIES POWDER CAPSULES IDENTIFICATION USP41–NF36 4595 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 4 of A. HPTLC for Articles of Botanical Origin <203>/For Capsules containing Echinacea angustifolia powder prepared from dried rhizome and roots/System suitability: Change
Standard solution B shows two major blue bands at about the… Read More
ECHINACEA SPECIES DRY EXTRACT TABLETS IDENTIFICATION USP41–NF36 4592 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 4 of A. HPTLC for Articles of Botanical Origin <203>/For Tablets containing Echinacea angustifolia Dry Extract/System suitability: Change
Standard solution B shows two major blue bands at about the middle section due to caftaric acid (… Read More
ECHINACEA SPECIES DRY EXTRACT CAPSULES IDENTIFICATION USP41–NF36 4590 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 4 of A. HPTLC for Articles of Botanical Origin <203>/For Capsules containing Echinacea angustifolia Dry Extract/System suitability: Change
Standard solution B shows two major blue bands at about the middle section due to caftaric acid (… Read More
POWDERED ECHINACEA PURPUREA EXTRACT IDENTIFICATION USP40–NF35 6944 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 3 of A. Thin-Layer Chromatography/Presence of chicoric acid and absence of echinacoside/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF… Read More
POWDERED ECHINACEA PURPUREA IDENTIFICATION USP40–NF35 6942 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 3 of A. Thin-Layer Chromatography/Presence of chicoric acid and absence of echinacoside/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF… Read More
ECHINACEA PURPUREA ROOT IDENTIFICATION USP40–NF35 6940 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 3 of A. Thin-Layer Chromatography/Presence of chicoric acid and absence of echinacoside/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF… Read More
ECHINACEA PURPUREA AERIAL PARTS IDENTIFICATION USP40–NF35 6937 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 3 of A. Thin-Layer Chromatography/Presence of chicoric acid and absence of echinacoside/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF… Read More
POWDERED ECHINACEA PALLIDA EXTRACT IDENTIFICATION USP40–NF35 6935 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside and absence of dicaffeoylquinic acid/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower R Read More
POWDERED ECHINACEA PALLIDA IDENTIFICATION USP40–NF35 6933 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside and absence of dicaffeoylquinic acid/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower R Read More
ECHINACEA PALLIDA IDENTIFICATION USP40–NF35 6931 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside and absence of dicaffeoylquinic acid/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower R Read More
POWDERED ECHINACEA ANGUSTIFOLIA EXTRACT IDENTIFICATION USP40–NF35 6928 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside and dicaffeoylquinic acid/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF Read More
POWDERED ECHINACEA ANGUSTIFOLIA IDENTIFICATION USP40–NF35 6926 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside and dicaffeoylquinic acid/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF Read More
ECHINACEA ANGUSTIFOLIA IDENTIFICATION USP40–NF35 6923 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside and dicaffeoylquinic acid/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF Read More
DOPAMINE HYDROCHLORIDE AND DEXTROSE INJECTION Identification USP40–NF35 3866 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of A: Change
It responds to the Identification test under Dextrose.
to:
Add a few drops of a solution (1 in 20) to 5 mL of hot alkaline cupric tartrate TS. A copious red precipitate of cuprous oxide is formed.
DOBUTAMINE IN DEXTROSE INJECTION Identification USP40–NF35 3843 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of B: Change
It meets the requirements for the Identification test under Dextrose.
to:
Add a few drops of a solution (1 in 20) to 5 mL of hot alkaline cupric tartrate TS. A copious red precipitate of cuprous oxide is formed.
POWDERED DIGITALIS IDENTIFICATION/B. Thin-Layer Chromatographic Identification Test USP40–NF35 3762 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 3 of Standard solution A: Change
lead acetate,
to:
lead acetate TS,
AND
Line 11 of Analysis: Change
Locate the two prominent bands from Standard solution A corresponding in RF value to the two bands from… Read More
BRETYLIUM TOSYLATE IN DEXTROSE INJECTION Identification USP40–NF35 3049 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of B: Change
It responds to the Identification test under Dextrose.
to:
Add a few drops of a solution (1 in 20) to 5 mL of hot alkaline cupric tartrate TS. A copious red precipitate of cuprous oxide is formed.
<1103> IMMUNOLOGICAL TEST METHODS—ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA) PROCEDURES/Solid Phase USP40–NF35 1344 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 7 of Coating the Solid Phase—Immobilization of Capture Reagent: Change
1–10 µg/well
to:
1–10 µg/mL
L104 CHROMATOGRAPHIC COLUMNS/Packings First Supplement to USP41–NF36 8503 1-Feb-2018 USP42–NF37 Second Supplement to USP41–NF36 Add
L104—Triazol groups chemically bonded to porous silica particles, 1.5–10 μm in diameter.
VALERIAN TABLETS IDENTIFICATION/A. Thin-Layer Chromatography USP40–NF35 7244 1-Jan-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of Chromatographic system/Developing solvent system:Change
acetic acid
to:
glacial acetic acid
AND
Line 2 ofChromatographic system/Derivatization reagent B: Change
aceticacid
to:
glacial acetic acid
VALERIAN TINCTURE IDENTIFICATION/A. Thin-Layer Chromatography USP40–NF35 7243 1-Jan-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of Chromatographic system/Developing solvent system:Change
acetic acid
to:
glacial acetic acid
AND
Line 2 ofChromatographic system/Derivatization reagent B: Change
aceticacid
to:
glacial acetic acid
POWDERED VALERIAN EXTRACT IDENTIFICATION/A. Thin-Layer Chromatography USP40–NF35 7241 1-Jan-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of Chromatographic system/Developing solvent system:Change
acetic acid
to:
glacial acetic acid
AND
Line 2 ofChromatographic system/Derivatization reagent B: Change
aceticacid
to:
glacial acetic acid
POWDERED VALERIAN IDENTIFICATION/C. Thin-Layer Chromatography USP40–NF35 7240 1-Jan-2018 USP42–NF37 Second Supplement to USP41–NF36
Line 2 of Chromatographic system/Developing solvent system:Change
acetic acid
to:
glacial acetic acid
AND
Line 2 ofChromatographic system/Derivatization reagent B: Change
aceticacid
to:
glacial acetic acid
VALERIAN IDENTIFICATION/C. Thin-Layer Chromatography USP40–NF35 7238 1-Jan-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of Chromatographic system/Developing solvent system:Change
acetic acid
to:
glacial acetic acid
AND
Line 2 ofChromatographic system/Derivatization reagent B: Change
aceticacid
to:
glacial acetic acid
OLMESARTAN MEDOXOMIL TABLETS ASSAY/Chromatographic system Revision Bulletin (Official August 01, 2017) ONLINE 1-Jan-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 1 of Detector: Change
Identification B
to:
Identification A