Errata - English

In B. Identification Tests—General 〈191〉, Chemical Identification Tests, Chloride: Change
Meets the requirements when tested as specified in test B.
to:
Meets the requirements of the test for amine hydrochlorides

Change
Shake a portion of Oral Suspension with a mixture of acetone and 0.1 N hydrochloric acid (4:1) to obtain a solution containing about 1 mg of amoxicillin per mL. The solution responds to the Identification test under Amoxicillin Capsules.
to:
Prepare a test solution by shaking a portion of Oral Suspension with a mixture of acetone and 0.1 N hydrochloric acid (4:1) to obtain a solution containing about 1 mg of amoxicillin per mL. Prepare a Standard solution of USP Amoxicillin RS in 0.1 N hydrochloric acid containing 1 mg per mL. Use within 10 minutes after preparation. Apply separately 5 µL of each solution on a thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture (see Chromatography 〈621〉). Place the plate in a suitable chromatographic chamber, and develop the chromatogram in a solvent system consisting of a mixture of methanol, chloroform, water, and pyridine (90:80:30:10). When the solvent front has moved about three-fourths of the length of the plate, remove the plate from the chamber, and dry with warm air for 10 minutes. Locate the spots on the plate by spraying lightly with a solution of ninhydrin in alcohol containing 3 mg per mL, and dry at 110° for 15 minutes: the R_F value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.

In Dissolution 〈711〉/Test 1/Analysis: Change
Result = (r_U/r_S) × C_S × V × (1/L) × 100
r_U = peak response of linezolid from the Sample solution
r_S = peak response of linezolid from the Standard solution
C_S = concentration of USP Linezolid RS in the Standard solution (mg/mL)
V = volume of Medium, 900 mL
L = label claim (mg/Tablet)
to:
Result = (r_U/r_S) × C_S × V × (1/L) × D × 100
r_U = peak response of linezolid from the Sample solution
r_S = peak response of linezolid from the Standard solution
C_S = concentration of USP Linezolid RS in the Standard solution (mg/mL)
V = volume of Medium, 900 mL
L = label claim (mg/Tablet)
D = dilution factor of the Sample solution, as needed

Change
A: The contents of the Capsules respond to Identification tests A and B under Theophylline Tablets.
B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
to:
A: Triturate a quantity of the contents of Capsules, equivalent to about 500 mg of theophylline, with 10-mL and 5-mL portions of solvent hexane, and discard the solvent hexane. Triturate the residue with two 10-mL portions of a mixture of equal volumes of 6 N ammonium hydroxide and water, and filter each time. Evaporate the combined filtrates to about 5 mL, neutralize, if necessary, with 6 N acetic acid, using litmus, and then cool to about 15°, with stirring. Collect the precipitate on a filter, wash it with cold water, and dry at 105° for 2 hours: the theophylline so obtained melts between 270° and 274° (see Melting Range or Temperature 〈741〉, Procedures, Procedure for Class I). Retain the remaining portion of the theophylline for use in Identification test B.
B: The IR absorption spectrum of a potassium bromide dispersion of the residue obtained in Identification test A exhibits maxima only at the same wavenumbers as that of a potassium bromide dispersion of USP Theophylline RS.
C: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.

In Acetic Acid in Peptides/Analysis: Change
C_SPA = concentration of potassium acetate in each of the Standard solutions (mg/mL)
to:
C_SPA = concentration of potassium acetate in each of the Standard solutions (µg/mL)
AND
In Ammonium/Analysis: Change
C_SAC = concentration of ammonium chloride in each of the Standard solutions (mg/mL)
to:
C_SAC = concentration of ammonium chloride in each of the Standard solutions (µg/mL)

Change
Where the label states that Seco barbital Sodium is sterile, it meets the requirements for Sterility Tests 〈71〉 and for Bacterial endotoxins under Secobarbital Sodium for Injection. Where the label states that Secobarbital Sodium must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements for Bacterial endotoxins under Secobarbital Sodium for Injection.
to:
Where the label states that Secobarbital Sodium is sterile, it meets the requirements for Sterility Tests 〈71〉 and the level of bacterial endotoxins is not more than 0.9 USP Endotoxin Units per mg of secobarbital sodium tested per Bacterial Endotoxins Test <85>. Where the label states that Secobarbital Sodium must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins is not more than 0.9 USP Endotoxin Units per mg of secobarbital sodium tested per Bacterial Endotoxins Test <85>.

Change
The solution obtained responds to the Identification test under Amoxicillin Capsules.
to:
Prepare a Standard solution of USP Amoxicillin RS in 0.1 N hydrochloric acid containing 4 mg per mL. Use within 10 minutes after preparation. Apply separately 5 µL of each solution on a thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture (see Chromatography <621>). Place the plate in a suitable chromatographic chamber, and develop the chromatogram in a solvent system consisting of a mixture of methanol, chloroform, water, and pyridine (90:80:30:10). When the solvent front has moved about three-fourths of the length of the plate, remove the plate from the chamber, and dry with warm air for 10 minutes. Locate the spots on the plate by spraying lightly with a solution of ninhydrin in alcohol containing 3 mg per mL, and dry at 110° for 15 minutes: the R_F value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.

In Dissolution 〈711〉/Test for dutasteride/Tier 2/Medium: Change
10 g/L of cetyltrimethylammonium bromide and 750,000 USP units of activity/mg of pepsin, purified in 0.1 N hydrochloric acid; 900 mL
to:
Dissolve 10 g of cetyltrimethylammonium bromide and 1.6 g of pepsin, purified in 1000 mL of 0.1 N hydrochloric acid; 900 mL

In USP Reference Standards 〈11〉/USP Cefdinir Related Compound A RS: Change
413.43
to:
413.42
AND
In USP Reference Standards 〈11〉/USP Cefdinir Related Compound B RS: Change
C₁₄H₁₃N₄O₄S₂ 365.41
to:
C₁₄H₁₄N₄O₄S₂ 366.41

In Organic Impurities/Table 2: Change
3'-N-Demethyl-3'-N-[(4-methylphenyl)sulfonyl]azithromycin^m
to:
3′-N-{[4-(Acetylamino)phenyl]sulfonyl}-3′-demethylazithromycin^m
AND
In Table 2/footnote m: Change
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-[N-(4-methylphenylsulfonyl)-N-methylamino]-3,4,6-trideoxy-ß-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.
to:
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-[N-(4-acetamidophenylsulfonyl)-N-methylamino]-3,4,6-trideoxy-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.

Change
Application volume, Developing solvent system, Procedure—Proceed as directed for the Identification test under Amoxicillin Tablets.
to:
Application volume—5 µL.
Developing solvent system—a mixture of methanol, chloroform, water, and pyridine (90:80:30:10).
Procedure—Proceed as directed in Thin-Layer Chromatographic Identification Test <201>. Dry the plate with the aid of a current of warm air for 10 minutes. Locate the spots on the plate by spraying lightly with a solution of ninhydrin in alcohol containing 3 mg per mL, and dry at 110° for 15 minutes.

In Dissolution 〈711〉/Test 2/Acid stage: Change
Acid stage standard solution: (L/10) mg/mL of USP Pantoprazole Sodium RS from the Standard stock solution in Acid stage medium, where L is the label claim in mg/Tablet
to:
Acid stage standard solution: (L/10000) mg/mL of USP Pantoprazole Sodium RS from the Standard stock solution in Acid stage medium, where L is the label claim in mg/Tablet
AND
In Dissolution <711>/Test 2/Buffer stage: Change
Buffer stage standard solution: (L/1000) of USP Pantoprazole Sodium RS where L is the label claim in mg/Tablet
to:
Buffer stage standard solution: (L/1000) mg/mL of USP Pantoprazole Sodium RS from the Standard stock solution in Buffer stage medium, where L is the label claim in mg/Tablet

In USP Reference Standards 〈11〉/USP Cefdinir Related Compound A RS: Change
413.43
to:
413.42
AND
In USP Reference Standards 〈11〉/USP Cefdinir Related Compound B RS: Change
C₁₄H₁₃N₄O₄S₂ 365.41
to:
C₁₄H₁₄N₄O₄S₂ 366.41

In Dissolution 〈711〉/Test 1/Analysis: Change
Determine the percentage of telmisartan (C₃₃H₃₀N₄O₂) dissolved:
Result = (A_U × C_S × V × 100)/(A_S × D × L)
to:
Calculate the percentage of the labeled amount of telmisartan (C₃₃H₃₀N₄O₂) dissolved:
Result = (A_U/A_S) × C_S × V × D × (1/L) × 100
AND
Change
C_S = concentration of the Standard solution (mg/mL)
to:
C_S = concentration of USP Telmisartan RS in the Standard solution (mg/mL)
AND
In Dissolution 〈711〉/Test 2/Analysis: Change
r_U = peak response from the Sample solution
r_S = peak response from the Standard solution
to:
r_U = peak response of telmisartan from the Sample solution
r_S = peak response of telmisartan from the Standard solution
AND
In Dissolution 〈711〉/Test 3/Analysis: Change
C_S = concentration of the Standard solution (mg/mL)
to:
C_S = concentration of USP Telmisartan RS in the Standard solution (mg/mL)

In Procedure/Analysis: Change
Calculate the percentage of methylbenzethonium chloride (C₂₈H₄₄ClNO₂ · H₂O) in the portion of Methylbenzethonium Chloride taken:
to:
Calculate the percentage of methylbenzethonium chloride (C₂₈H₄₄ClNO₂) in the portion of Methylbenzethonium Chloride taken:

Change
Prepare a test solution containing the equivalent of 4 mg of amoxicillin per mL by adding 0.1 N hydrochloric acid to Amoxicillin for Injectable Suspension. Allow the solution to stand for 5 minutes before use: the solution responds to the Identification test under Amoxicillin Capsules.
to:
Prepare a test solution containing the equivalent of 4 mg of amoxicillin per mL by adding 0.1 N hydrochloric acid to Amoxicillin for Injectable Suspension. Allow the solution to stand for 5 minutes before use. Prepare a Standard solution of USP Amoxicillin RS in 0.1 N hydrochloric acid containing 4 mg per mL. Use within 10 minutes after preparation. Apply separately 5 µL of each solution on a thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture (see Chromatography <621>). Place the plate in a suitable chromatographic chamber, and develop the chromatogram in a solvent system consisting of a mixture of methanol, chloroform, water, and pyridine (90:80:30:10). When the solvent front has moved about three-fourths of the length of the plate, remove the plate from the chamber, and dry with warm air for 10 minutes. Locate the spots on the plate by spraying lightly with a solution of ninhydrin in alcohol containing 3 mg per mL, and dry at 110° for 15 minutes: the R_F value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.

In Vitamin A, Method 3/Analysis: Change
C_S = concentration of retinyl acetate (C₂₃H₃₂O₂) from USP Vitamin A RS in the Standard solution (μg/mL)
to:
C_S = concentration of retinyl acetate (C₂₂H₃₂O₂) from USP Vitamin A RS in the Standard solution (μg/mL)

In Alcohol-Insoluble Matter/Sample solution: Change
100 mg/mL of Urea dissolved in warm alcohol
to:
Dissolve 5.0 g of Urea in 50 mL of warm alcohol.
AND
In Alcohol-Insoluble Matter/Analysis: Change
If any insoluble residue remains, pass the Sample solution through a tared filter, wash the residue and the filter with 20 mL of warm alcohol per 50 mL of Sample solution, and dry at 105° for 1 h.
to:
If any insoluble residue remains, pass the Sample solution through a tared filter, wash the residue and the filter with 20 mL of warm alcohol, and dry at 105° for 1 h.

In Procedure/System suitability/Suitability requirements: Change
Resolution: NLT 3 between telmisartan and telmisartan related compound A
Tailing factor: NMT 2.0 for the telmisartan peak
Capacity factor: NLT 1.5
Relative standard deviation: NMT 2.0%
to:
Resolution: NLT 3 between telmisartan and telmisartan related compound A
Tailing factor: NMT 2.0 for telmisartan
Relative standard deviation: NMT 2.0% for telmisartan

In Vitamin A, Method 3/Analysis: Change
C_S = concentration of retinyl acetate (C₂₃H₃₂O₂) from USP Vitamin A RS in the Standard solution (μg/mL)
to:
C_S = concentration of retinyl acetate (C₂₂H₃₂O₂) from USP Vitamin A RS in the Standard solution (μg/mL)

In Organic Impurities/System suitability: Change
Sample: Standard solution
[Note—The relative retention times for methoxy tamsulosin, tamsulosin, ethoxyphenoxy ethyl bromide, and desethoxy tamsulosin are 0.73, 1.00, 1.80, and 2.80, respectively.]
Suitability requirements
Tailing factor: NMT 2.0
Relative standard deviation: NMT 5.0%
Signal-to-noise ratio: NLT 10
to:
Samples: Standard solution and Sensitivity solution
[Note—The relative retention times for methoxy tamsulosin, tamsulosin, ethoxyphenoxy ethyl bromide, and desethoxy tamsulosin are 0.73, 1.00, 1.80, and 2.80, respectively.]
Suitability requirements
Tailing factor: NMT 2.0, Standard solution
Relative standard deviation: NMT 5.0%, Standard solution
Signal-to-noise ratio: NLT 10, Sensitivity solution

In Dissolution 〈711〉/Test 8/Tolerances: Change
The percentage of the labeled amount of valproic acid (C₈H₁₆O₂) dissolved at the times specified conform to Dissolution <711>, Acceptance Table 1.
to:
The percentage of the labeled amount of valproic acid (C₈H₁₆O₂) dissolved at the times specified conform to Dissolution <711>, Acceptance Table 2.

In Organic Impurities/Table 3/footnote c: Change
2-[(2-Amino-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy]-2-hydroxypropyl methyl-L-valinate hydrochloride.
to:
3-[(2-Amino-6-oxo-1,6-dihydropurin-9-yl)methoxy]-2-hydroxypropyl L-valinate hydrochloride.

In Dissolution <711>/Test 1/Procedure/Chromatographic procedure/Analysis: Change
Result = (R_U/R_S) × C_S × V × (1/L) × 100
to:
Result = (R_U/R_S) × C_S × V × D × (1/L) × 100
AND
Add
D = dilution factor of the Sample solution, 2

In A./Standard solution B: Change
USP Procyanidin A₂ RS
to:
USP Procyanidin A2 RS
AND
In A./System suitability/Suitability requirements/Derivatization reagent B/White light: Change
Standard solution B exhibits two brown bands in the upper-half section corresponding to procyanidin A₂ and epicatechin. Standard solution C exhibits two brown bands in the upper-half section corresponding in R_F and color to procyanidin A₂ and epicatechin in Standard solution B. Standard solution C also exhibits a series of faint or indistinct brown bands of differing intensities below procyanidin A₂ in the lower-half section.
to:
Standard solution B exhibits two brown bands in the upper-half section corresponding to procyanidin A2 and epicatechin. Standard solution C exhibits two brown bands in the upper-half section corresponding in R_F and color to procyanidin A2 and epicatechin in Standard solution B. Standard solution C also exhibits a series of faint or indistinct brown bands of differing intensities below procyanidin A2 in the lower-half section.
AND
In A./Acceptance criteria/Derivatization reagent B/White light: Change
The Sample solution exhibits two faint brown bands corresponding in R_F to procyanidin A₂ and epicatechin in Standard solution B. The Sample solution also exhibits a series of faint or indistinct brown bands of differing intensities in the lower-half section, corresponding to the same bands in Standard solution C. No bands corresponding in R_F to epigallocatechin-3-O-gallate, procyanidin B₂, or procyanidin B₁ appear below procyanidin A₂.
to:
The Sample solution exhibits two faint brown bands corresponding in R_F to procyanidin A2 and epicatechin in Standard solution B. The Sample solution also exhibits a series of faint or indistinct brown bands of differing intensities in the lower-half section, corresponding to the same bands in Standard solution C. No bands corresponding in R_F to epigallocatechin-3-O-gallate, procyanidin B2, or procyanidin B1 appear below procyanidin A2.
AND
In C./Acceptance criteria/Profile at 520 nm: Change
cyanidin-3-O-arabinose,
to:
cyanidin-3-O-arabinoside,
AND
In C./Acceptance criteria/Profile at 520 nm: Change
peonidin-3-O-arabinose
to:
peonidin-3-O-arabinoside

In Organic Impurities/Table 2: Change:
3′-N-{[4-(Acetylamino)phenyl]sulfonyl}-3′-demethylazithromycin^m
to:
3’-N-Demethyl-3’-N-[(4-methylphenyl)sulfonyl]azithromycin^m
AND
In Organic Impurities/Table 2/footnote m: Change
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-[N-(4-acetamidophenylsulfonyl)-N-methylamino]-3,4,6-trideoxy-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.
to:
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-[N-(4-methylphenylsulfonyl)-N-methylamino]-3,4,6-trideoxy-ß-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.

In Chromatographic system and Procedure: Change
C is the concentration, in mg per mL, of USP Dextromethorphan Hydrobromide RS, on the anhydrous basis, in the Standard preparation;
to:
C is the concentration, in mg per mL, of USP Dextromethorphan Hydrobromide RS in the Standard preparation;