Errata - English

Change
Solution A, Solution B, Mobile phase, Internal standard solution, and Chromatographic system—Prepare as directed in the Assay under Dimenhydrinate Tablets.
to:
Solution A—Dissolve 0.8 g of ammonium bicarbonate in 800 mL of water. Add 200 mL of methanol, filter, and degas.
Solution B—Dissolve 0.8 g of ammonium bicarbonate in 150 mL of water. Add 850 mL of methanol, filter, and degas.
Mobile phase—Use variable mixtures of Solution A and Solution B as directed for Chromatographic system. Make adjustments if necessary (see System Suitability under Chromatography 〈621〉).
Internal standard solution—Prepare a solution in methanol containing 2.0 mg of 2-hydroxybenzyl alcohol per mL.
AND
Add
Chromatographic system (see Chromatography 〈621〉)—
The liquid chromatograph is equipped with a 229-nm detector and a 4.6-mm × 25-cm column that contains packing L7. The flow rate is about 1.5 mL per minute. The chromatograph is programmed as follows.

Time (minutes), 0, 0–7.0, 7.0–7.1, 7.1–15, 15–15.1, 15.1–22.0
Solution A (%), 100, 100, 100→0, 0, 0→100, 100
Solution B (%), 0, 0, 0→100, 100, 100→0, 0
Elution, equilibration, isocratic, linear gradient, isocratic, linear gradient, isocratic

Chromatograph the Standard preparation, and record the peak areas as directed for Procedure: the relative retention times are about 0.3 for 8-chlorotheophylline, 0.5 for the internal standard, and 1.0 for diphenhydramine; the resolution, R, between 8-chlorotheophylline and the internal standard is not less than 4.5; and the relative standard deviation for replicate injections is not more than 2.0%.
AND
Change
Procedure—Proceed as directed for Procedure in the Assay under Dimenhydrinate Tablets. Calculate the quantity, in mg, of dimenhydrinate (C₁₇H₂₁NO · C₇H₇ClN₄O₂) in each mL of the Injection taken by the formula:
(200C/V)(R_U/R_S)
in which C is the concentration of USP Dimenhydrinate RS in the Standard preparation; V is the volume, in mL, of Injection taken; and the other terms are as defined therein.
to:
Procedure— Separately inject equal volumes (about 10 μL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the areas for the major peaks. Calculate the quantity, in mg, of dimenhydrinate (C₁₇H₂₁NO · C₇H₇ClN₄O₂) in each mL of the Injection taken by the formula:
(200C/V)(R_U/R_S)
in which C is the concentration of USP Dimenhydrinate RS in the Standard preparation; V is the volume, in mL, of Injection taken; and R_U and R_S are the peak area ratios of diphenhydramine to the internal standard obtained from the Assay preparation and the Standard preparation, respectively.

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.

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).

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 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 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 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 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

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 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

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 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