Errata - English

Change
Similarly, a specific gravity value of 0.8092 in column 1 corresponds to a solution that contains 95% alcohol by weight or 92.42% alcohol v/v.
to:
Similarly, a specific gravity value of 0.8092 in column 1 corresponds to a solution that contains 95% alcohol v/v or 92.42% alcohol by weight.

In USP Ziprasidone Related Compound F RS: Change
2-(2-Amino-5-{2-[4-(benzo[d]isothiazol-3-yl)piperazin-1-yl]ethyl}-4-chlorophenyl)acetic acid.
C₂₁H₂₃ClN₄O₂S 430.95
to:
Sodium 2-(2-amino-5-{2-[4-(benzisothiazol-3-yl)piperazin-1-yl]ethyl}-4-chlorophenyl)acetate monohydrate;
Also known as Sodium 2-(2-amino-5-{2-[4-(benzo[d]isothiazol-3-yl)piperazin-1-yl]ethyl}-4-chlorophenyl)acetate monohydrate.
C₂₁H₂₂ClN₄NaO₂S · H₂O 470.95

Change
Apparatus 5 (see general chapter Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests 〈601〉), a cascade impactor, has been calibrated at 15 L/min specifically to meet the recommendation of the CEN Standard and is therefore used for this test.³
to:
The Next Generation Impactor without pre-separator used with inhalation aerosols, inhalation sprays, and nasal aerosols is described in Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests 〈601〉. An archival version of this cascade impactor has been calibrated at 15 L/min specifically to meet the recommendation of the CEN Standard and this configuration is therefore used for this test.³
AND
In Apparatus: Change
A detailed description of Apparatus 5 and the induction port is contained in 〈601〉, and includes details of
to:
Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests <601>, C.4 Next Generation Impactor without Pre-separator for Inhalation Aerosols, Inhalation Sprays, and Nasal Aerosols includes details of
AND
In Procedure: Change
Figure 2. Apparatus 5 for Measuring the Size Distribution of Products for Nebulization.
to:
Figure 2. Next Generation Impactor without Pre-separator for Measuring the Size Distribution of Products for Nebulization.
AND
In Procedure: Change
on the back-up filter as described for Apparatus 5 (see 〈601〉).
to:
on the back-up filter as described in Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests <601>, C.4 Next Generation Impactor without Pre-separator for Inhalation Aerosols, Inhalation Sprays, and Nasal Aerosols.
AND
In Procedure: Change
Determine the cumulative mass-weighted particle-size distribution of the aerosol size-fractionated by the impactor in accordance with the procedure given in 〈601〉.
to:
Determine the cumulative mass-weighted particle-size distribution of the aerosol size-fractionated by the impactor in accordance with the procedure given in Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests <601>, C.4 Next Generation Impactor without Pre-separator for Inhalation Aerosols, Inhalation Sprays, and Nasal Aerosols.
AND
In Table 2: Change
Table 2. Cut-off Sizes for Apparatus 5 at 15 L/min
to:
Table 2. Cut-off Sizes for Next Generation Impactor without Pre-separator at 15 L/min

In Test 3/Analysis: Change
Result = (r_U/r_S) × C_S × D
r_U = peak response from the Sample solution
r_S = peak response from the Standard solution
C_S = concentration of the Standard solution (mg/mL)
D = dilution factor of the Sample solution, 50
to:
Result = (A_U/A_S) × C_S × D
A_U = absorbance from the Sample solution
A_S = absorbance from the Standard solution
C_S = concentration of the Standard solution (mg/mL)
D = dilution factor of the Sample solution, 50

In A.: Change
Render the filtrate alkaline with 6 N ammonium hydroxide, extract with several small portions of chloroform, and proceed as directed in Identification test A under Codeine Phosphate Injection, beginning with “Evaporate the combined chloroform extracts.” The specified results are observed.
to:
Render the filtrate alkaline with 6 N ammonium hydroxide and extract with several small portions of chloroform. Evaporate the combined chloroform extracts on a steam bath to dryness, and dry at 80° for 4 hours: the IR absorption spectrum of a potassium bromide dispersion of the residue so obtained exhibits maxima at the same wavelengths as that of the codeine obtained by similarly treating 1 mL of a solution of USP Codeine Phosphate RS (1 in 100).

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