Errata - English

In Chromatographic system: Change
The liquid chromatograph is equipped with a 216-nm detector and a 4.6-mm × 20-cm column that contains packing L10.
to:
The liquid chromatograph is equipped with a 216-nm detector and a 4.6-mm × 25-cm column that contains packing L10.

Change
A 1-mL portion of the filtrate from Identification test B meets the requirements of the test for Limit of morphine under Codeine Phosphate.
to:
Dissolve about 50 mg of potassium ferricyanide in 10 mL of water, and add 1 drop of ferric chloride TS and a 1-mL portion of the filtrate from Identification test B: no blue color is produced immediately.

In USP Benazepril Related Compound B RS: Change
(3S) 3-[[(1R) 1-(Ethoxycarbonyl)-3-phenylpropyl] amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid, monohydrochloride;
Also known as 2-[(SR)-3-{[(RS)-1-Ethoxy-1-oxo-4-phenylbutan-2-yl]amino}-2-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl]acetic acid hydrochloride.
to:
2-[(S)-3-{[(R)-1-Ethoxy-1-oxo-4-phenylbutan-2-yl]amino}-2-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl]acetic acid hydrochloride;
Also known as (3S) 3-[[(1R)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid, monohydrochloride.

Change
Mobile phase, Diluent, System suitability solution, Standard solution, and Sample solution: Proceed as directed in the Assay.
to:
Mobile phase, Diluent, System suitability solution, Standard solution, Sample solution, and System suitability: Proceed as directed in the Assay.

In USP Benazepril Related Compound A RS: Change
(3R) 3-[[(1R) 1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid, monohydrochloride.
to:
2-[(R)-3-{[(R)-1-Ethoxy-1-oxo-4-phenylbutan-2-yl]amino}-2-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl]acetic acid hydrochloride;
Also known as (3R) 3-[[(1R)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid, monohydrochloride.
AND
In USP Benazepril Related Compound B RS: Change
(3S) 3-[[(1R) 1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid, monohydrochloride.
to:
2-[(S)-3-{[(R)-1-Ethoxy-1-oxo-4-phenylbutan-2-yl]amino}-2-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl]acetic acid hydrochloride;
Also known as (3S) 3-[[(1R)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid, monohydrochloride.
AND
In USP Benazepril Related Compound C RS: Change
3-(1-Carboxy-3-phenyl-1(S)-propyl)amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid.
to:
(S)-2-{[(S)-1-(Carboxymethyl)-2-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepin-3-yl]amino}-4-phenylbutanoic acid;
Also known as 3-(1-Carboxy-3-phenyl-1(S)-propyl)amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid.
AND
In USP Benazepril Related Compound D RS: Change
(3-(1-Ethoxycarbonyl-3-cyclohexyl-(1S)-propyl)amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine)-1-acetic acid, monohydrochloride.
to:
2-[(S)-3-{[(S)-4-Cyclohexyl-1-ethoxy-1-oxobutan-2-yl]amino}-2-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl]acetic acid hydrochloride;
Also known as (3-(1-Ethoxycarbonyl-3-cyclohexyl-(1S)-propyl)amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine)-1-acetic acid, monohydrochloride.
AND
In USP Benazepril Related Compound E RS: Change
3-Amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid.
to:
(S)-2-(3-Amino-2-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl)acetic acid hydrochloride;
Also known as 3-Amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride.
C₁₂H₁₄N₂O₃ · HCl 270.71
AND
In USP Benazepril Related Compound F RS: Change
tert-Butyl-3-amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid.
to:
tert-Butyl (S)-2-(3-amino-2-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl)acetate;
Also known as tert-Butyl-3-amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid.
C₁₆H₂₂N₂O₃ 290.36
AND
In USP Benazepril Related Compound G RS: Change
(3-(1-Ethoxycarbonyl-3-phenyl-(1S)-propyl)amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine)-1-acetic acid ethyl ester.
to:
Ethyl (S)-2-{[(S)-1-(2-ethoxy-2-oxoethyl)-2-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepin-3-yl]amino}-4-phenylbutanoate;
Also known as (3-(1-Ethoxycarbonyl-3-phenyl-(1S)-propyl)amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine)-1-acetic acid ethyl ester.
C₂₆H₃₂N₂O₅ 452.55

In USP Lansoprazole Related Compound B RS: Change
2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-pyridin-2-yl] methyl]sulfanyl]-1H-benzimidazole.
C₁₆H₁₄F₃N₃OS 353.36
to:
2-{[(3-Methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl)methyl]thio}benzimidazole monohydrate.
C₁₆H₁₄F₃N₃OS · H₂O 371.38

In USP Benazepril Related Compound B RS: Change
(3S)-3-[[(1R)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid, monohydrochloride;
Also known as 2-[(SR)-3-{[(RS)-1-Ethoxy-1-oxo-4-phenylbutan-2-yl]amino}-2-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl]acetic acid hydrochloride.
to:
2-[(S)-3-{[(R)-1-Ethoxy-1-oxo-4-phenylbutan-2-yl]amino}-2-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl]acetic acid hydrochloride;
Also known as (3S)-3-[[(1R)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid, monohydrochloride.

In Limit of Ethyl Acetate and Cyclohexane/Analysis: Change
Samples: Standard stock solution, Standard solution A, Standard solution B, Standard solution C, and Sample solution
to:
Samples: Standard solution A, Standard solution B, Standard solution C, and Sample solution
AND
In Limit of Benzene/Analysis: Change
Samples: Standard stock solution, Standard solution A, Standard solution B, Standard solution C, and Sample solution
to:
Samples: Standard solution A, Standard solution B, Standard solution C, and Sample solution

In Limit of Ethyl Acetate and Cyclohexane/Analysis: Change
Samples: Standard stock solution, Standard solution A, Standard solution B, Standard solution C, and Sample solution
to:
Samples: Standard solution A, Standard solution B, Standard solution C, and Sample solution
AND
In Limit of Benzene/Analysis: Change
Samples: Standard stock solution, Standard solution A, Standard solution B, Standard solution C, and Sample solution
to:
Samples: Standard solution A, Standard solution B, Standard solution C, and Sample solution

In Limit of Ethyl Acetate and Cyclohexane/Analysis: Change
Samples: Standard stock solution, Standard solution A, Standard solution B, Standard solution C, and Sample solution
to:
Samples: Standard solution A, Standard solution B, Standard solution C, and Sample solution
AND
In Limit of Benzene/Analysis: Change
Samples: Standard stock solution, Standard solution A, Standard solution B, Standard solution C, and Sample solution
to:
Samples: Standard solution A, Standard solution B, Standard solution C, and Sample solution

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 retention times for niacinamide, pyridoxine, and folic acid are about 1.0, 2.0, and 3.0, respectively.]
AND
In Vitamins B1 (as Thiamine Ion) and B2 (as Riboflavin), Method 1; Vitamin C (as Ascorbic Acid), Vitamins B3 (as Niacinamide), B6 (as Pyridoxine), and Folic Acid, Method 2/Analysis: Change
Calculate the percentage of the labeled amount of vitamin B1 as thiamine ion (C₁₂H₁₇N₄OS⁺), vitamin B2 as riboflavin (C₁₇H₂₀N₄O₆), vitamin B3 as niacinamide (C₆H₆N₂O), vitamin B6 as pyridoxine (C₈H₁₁NO₃), and folic acid (C₁₉H₁₉N₇O₆), in the portion of Chewable Gels taken:
to:
Calculate the percentage of the labeled amount of vitamin C as ascorbic acid (C₆H₈O₆), vitamin B1 as thiamine ion (C₁₂H₁₇N₄OS⁺), vitamin B2 as riboflavin (C₁₇H₂₀N₄O₆), vitamin B3 as niacinamide (C₆H₆N₂O), vitamin B6 as pyridoxine (C₈H₁₁NO₃), and folic acid (C₁₉H₁₉N₇O₆), in the portion of Chewable Gels taken:
AND
In Vitamins B1 (as Thiamine Ion) and B2 (as Riboflavin), Method 1; Vitamin C (as Ascorbic Acid), Vitamins B3 (as Niacinamide), B6 (as Pyridoxine), and Folic Acid, Method 2/Acceptance criteria: Change
90.0%–150.0% of the labeled amounts of vitamin B3 as niacinamide, vitamin B6 as pyridoxine, riboflavin, and thiamine as thiamine ion (C₁₂H₁₇N₄OS⁺); and NLT 90.0% and NMT 245.0% of the labeled amount of folic acid
to:
90.0%–250.0% of the labeled amount of vitamin C as ascorbic acid; 90.0%–150.0% of the labeled amounts of vitamin B3 as niacinamide, vitamin B6 as pyridoxine, riboflavin, and thiamine as thiamine ion (C₁₂H₁₇N₄OS⁺); and NLT 90.0% and NMT 245.0% of the labeled amount of folic acid

In Medium: Change
Sodium phosphate buffer, pH of 6.0 (14.2 g/L of disodium hydrogen orthophosphate anhydrous in water, adjusted with dilute hydrochloric acid to a pH of 6.0)
to:
Sodium phosphate buffer, pH 6.0 (14.2 g/L of sodium phosphate, dibasic, anhydrous in water, adjusted with dilute hydrochloric acid to pH 6.0)
AND
In Solution A: Change
orthophosphoric acid
to:
phosphoric acid

Change
489.64
to:
489.65
AND
Change
(Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(E)-(3S)-3-hydroxy-3-methyl-1-octenyl]cyclopentyl]-5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1);
to:
(Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(E)-(3S)-3-hydroxy-3-methyloct-1-enyl]cyclopentyl]-5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1);

In USP Mirtazapine Resolution Mixture RS: Change
Impurity D: 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine.
to:
Impurity D: [Note–This impurity may be available either as the free base form or as the hydrochloride salt form.] 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine or 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine hydrochloride.

In Light-resistant container: Change
〈661.2〉, Functionality, Spectral Transmission Requirements for Light-Resistant Components and Systems.
to:
〈661.2〉, Functionality Test Method, Spectral Transmission Requirements for Light-Resistant Components and Systems.

In USP Amoxicillin Related Compound A RS: Change
(2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid.
C₁₆H₁₄N₂O₂ 266.29
to:
(2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid.
C₈H₁₂N₂O₃S 216.26

In USP Riluzole Related Compound A RS: Change
4-Trifluoromethoxyphenylamine; 4-trifluoromethoxyanaline.
C₇H₆F₃NO 177.12
to:
4-(Trifluoromethoxy)aniline.
C₇H₆F₃NO 177.13

In USP Mirtazapine Resolution Mixture RS: Change
Impurity D: 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine.
to:
Impurity D: [Note–This impurity may be available either as the free base form or as the hydrochloride salt form.] 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine or 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine hydrochloride.