Errata - English

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 A.: Change
Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197A, 197K, and 197S
to:
Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197A, 197K, or 197S
Procedure for 197S

Change
Characteristic emission lines for calcium at 184.0, 315.9, and 317.9 nm from the Sample solution correspond to those from the Standard solution, as obtained in the Assay.
to:
Characteristic emission lines for calcium at 184.0, 315.9, and 317.9 nm from the Sample solution correspond to those from the Standard solution, as obtained in the Content of Calcium.

Change
The spectrum obtained from the Sample solution shows IR maxima in the regions of 3500–3200, 2950–2890, 1653–1633, and 1070–1000 cm^–1.
to:
The spectrum obtained from the sample preparation shows IR maxima in the regions of 3500–3200, 2950–2890, 1653–1633, and 1070–1000 cm^–1.

Change
Related Compounds
System suitability solution and Sample solution: Prepare as directed in the Assay.
Analysis
Samples: System suitability solution and Sample solution
Using the chromatograms of the Sample solution and the System suitability solution, calculate the percentage of atovaquone related compounds in the portion of Atovaquone taken:
to:
Organic Impurities
Mobile phase, Diluent, System suitability solution, Standard solution, Sample solution, Chromatographic system and System suitability: Proceed as directed in the Assay.
Analysis
Sample: Sample solution
Calculate the percentage of atovaquone related compounds in the portion of Atovaquone taken:

In Organic Impurities/Standard solution: Change
isosorbide related compound A
to:
isosorbide mononitrate related compound A
AND
In System suitability/Suitability requirements/Relative standard deviation: Change
isosorbide related compound A,
to:
isosorbide mononitrate related compound A,
AND
In four instances in Analysis: Change
isosorbide related compound A,
to:
isosorbide mononitrate related compound A,
AND
In Table 1: Change
Isosorbide related compound A
to:
Isosorbide mononitrate related compound A

In Organic Impurities/Standard solution: Change
isosorbide related compound A
to:
isosorbide mononitrate related compound A
AND
In System suitability/Suitability requirements/Relative standard deviation: Change
isosorbide related compound A,
to:
isosorbide mononitrate related compound A,
AND
In four instances in Analysis: Change
isosorbide related compound A,
to:
isosorbide mononitrate related compound A,
AND
In Table 1: Change
Isosorbide related compound A
to:
Isosorbide mononitrate related compound A

In Organic Impurities/Solution B: Change
Acetonitrile, methanol, and Buffer (55:5:40). Adjust with potassium hydroxide TS to a pH of 6.0.
to:
Acetonitrile, methanol, and Buffer (55:5:40). Adjust with potassium hydroxide solution to a pH of 6.0.
AND
In both equations in Organic Impurities/Analysis: Change
449.40
to:
449.39

In Limit of Methanol (Methyl Alcohol) and Methyl Acetate/Analysis: Change
C_U = concentration of methanol (methyl alcohol) or methyl acetate in the Sample solution (mg/mL)
to:
C_U = concentration of Polyvinyl Alcohol in the Sample solution (mg/mL)

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.

In Sulfite/Analysis/footnote 1: Change
Test kit for sulfite determination may be ordered from the following suppliers: Megazyme Ltd. (Product code: K-ETSULPH); R-Biopharm (Enzytec) (Article No.: E6275); BioSenTec/Nzytech (Catalogue No.: AK00071).
to:
Test kit for sulfite determination may be ordered from the following suppliers: Megazyme Ltd. (Product code K-ETSULPH); R-Biopharm (Enzytec) (Article No. E6275); Nzytech (Catalogue No. AK00071) and BioSenTec (Product reference 040-E).

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 footnote m in Table 2: 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 Organic Impurities, Procedure 2/footnote 4: Change
5-[[3-[[3-[[[3-[[3-[[3,5-Bis-[[[2,3-dihydroxypropyl]amino]carbonyl]-2,4,6-triiodophenyl](acetylimino)]-2-hydroxypropyl](acetylimino)]-5-[[[2,3-dihydroxypropyl]amino]carbonyl]-2,4,6-triiodophenyl]carbonyl]amino]-2-hy droxypropyl]oxy]-2-hydroxypropyl](acetylimino)]-N,N'-bis(2,3-dihy droxypropyl)-2,4,6-triiodo-1,3-benzendicarboxamide.
to:
5-[[3-[[3-[[[3-[[3-[[3,5-Bis-[[[2,3-dihydroxypropyl]amino]carbonyl]-2,4,6-triiodophenyl](acetylamino)]-2-hydroxypropyl](acetylamino)]-5-[[[2,3-dihydroxypropyl]amino]carbonyl]-2,4,6-triiodophenyl]carbonyl]amino]-2-hydroxypropyl]oxy]-2-hydroxypropyl](acetylamino)]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzendicarboxamide.

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 Leachable Arsenic/Analysis: Change
A 3.0-mL portion of the Sample solution meets the requirements in Arsenic 〈211〉, Procedures, Procedure.
to:
A 3.0-mL portion of the Sample solution meets the requirements in Arsenic 〈211〉, Procedures, Procedure 1.

In Limit of Naloxone Related Compound D: Delete
Sensitivity solution: 1.25 µg/mL of USP Naloxone Related Compound D RS in 0.1 N hydrochloric acid
AND
In System suitability/Samples: Delete
Sensitivity solution,
AND
In System suitability/Suitability requirements: Delete
Signal-to-noise ratio: NLT 10, Sensitivity solution

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 Limit of Unspecified Impurities: Change
Mobile phase and Chromatographic system: Proceed as directed in the Assay.
to:
Mobile phase, Standard stock solution, and Chromatographic system: Proceed as directed in the Assay.

In Standard solution: Change
7.5 µg/mL of USP 2-Methylbenzhydrol RS in methanol
to:
7.5 µg/mL of USP Methylbenzhydrol RS in methanol
AND
In Analysis: Change
C_S = concentration of USP 2-Methylbenzhydrol RS in the Standard solution (mg/mL)
to:
C_S = concentration of USP Methylbenzhydrol RS in the Standard solution (mg/mL)

Change
Standard solution: 1.0 µg/mL of USP p-Chloroaniline RS in Diluent
to:
Standard solution: 0.001 mg/mL of USP p-Chloroaniline RS in Diluent
AND
In Analysis: Change
Result = (r_U/r_S) × (C_S/C_U) × D × 100
to:
Result = (r_U/r_S) × (C_S/C_U) × 100
AND
Delete
D = dilution factor for the Sample solution, 2.5

In Analysis: Change
Calculate the percentage of any unspecified impurities in the portion of Sotalol Hydrochloride taken:
Result = (r_U/r_S) × (C_S/C_U) × 100
r_U= sum of all the peak responses of all unspecified impurities from the Sample solution
to:
Calculate the percentage of any unspecified impurity in the portion of Sotalol Hydrochloride taken:
Result = (r_U/r_S) × (C_S/C_U) × 100
r_U = peak response of each unspecified impurity from the Sample solution
AND
In Table 1: Change
Any unspecified impurities
to:
Any unspecified impurity

In Table 2, footnote b: Change
(4S,4aR,5S,5aR,6R,12aS)-2-Acetyl-4-(dimethylamino)-4a,5a,6,12a-tetrahydro-3,5,10,12,12a-pentahydroxy-6-methyl-tetracene-1,11-dioxo-2-naphthacenecarboxamide.
to:
(4S,4aR,5S,5aR,6R,12aS)-2-Acetyl-4-(dimethylamino)-3,5,10,12,12a-pentahydroxy-6-methyl-4a,5a,6,12a-tetrahydrotetracene-1,11(4H,5H)-dione.

In Analysis: Change
M_r1 = molecular weight of atorvastatin, 558.64
M_r2 = molecular weight of atorvastatin calcium, 1155.34
to:
M_r1 = molecular weight of atorvastatin, 558.65
M_r2 = molecular weight of atorvastatin calcium, 1155.36

In Analysis: Change
C_S = concentration of the corresponding USP Doxazosin Related Compound RS or USP Doxazosin Mesylate RS (for calculating unspecified impurities) in the Standard solution (mg/mL)
to:
C_S = concentration of the corresponding USP Reference Standard or USP Doxazosin Mesylate RS (for calculating unspecified impurities) in the Standard solution (mg/mL)