Errata - English

Change
Proceed as directed in Identification test A under Metaproterenol Sulfate Inhalation Solution, beginning with “Allow the spots to dry”:
to:
Allow the spots to dry, and develop the chromatogram in a solvent system consisting of the upper layer of a freshly prepared mixture of butyl alcohol, water, and formic acid (50:25:7) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, mark the solvent front, and allow the solvent to evaporate. Locate the spots on the plate by examination under short-wavelength UV light:

Change
It responds to the Identification test under Penicillin G Benzathine Oral Suspension.
to:
Mix a portion of it with methanol to obtain a solution containing about 3000 Penicillin G Units per mL. Apply 20 µL of this test solution and 20 µL of a Standard solution of USP Penicillin G Benzathine RS in methanol containing 2.5 mg per mL to a suitable thin-layer chromatographic plate (see Chromatography 〈621〉) coated with a 0.25-mm layer of chromatographic silica gel, and allow the spots to dry. Using an unlined developing chamber, develop the chromatogram in a solvent system consisting of a mixture of methanol, acetonitrile, and ammonium hydroxide (70:30:3) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, and allow to air-dry. Spray the plate uniformly with a spray reagent prepared as follows. Dissolve 20 g of tartaric acid and 1.7 g of bismuth subnitrate in 80 mL of water. Add 2.5 mL of this solution, 2.5 mL of potassium iodide solution (4 in 10), and 10 g of tartaric acid to 50 mL of water, and mix. Examine the chromatograms: the principal spot obtained from the test solution corresponds in R_F value 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 System suitability: Change
[Note—The approximate relative retention times for (3S,3′S)-zeaxanthin, (3R,3′S-meso)-zeaxanthin, (3R,3′R)-zeaxanthin, and (3R,3′R,6′R)-lutein are 0.94, 1.00, 1.06, and 1.11, respectively.]
to:
[Note—The approximate relative retention times for (3S,3′S)-zeaxanthin, (3R,3′S)-zeaxanthin, (3R,3′R)-zeaxanthin, and (3R,3′R,6′R)-lutein are 0.94, 1.00, 1.06, and 1.11, respectively.]
AND
In System suitability/Suitability requirements/Resolution: Change
(3R,3′S-meso)-zeaxanthin
to:
(3R,3′S)-zeaxanthin
AND
In Analysis: Change
(3R,3′S-meso)-zeaxanthin
to:
(3R,3′S)-zeaxanthin
AND
In Acceptance criteria: Change
(3R,3′S-meso)-Zeaxanthin
to:
(3R,3′S)-Zeaxanthin

In footnote 1 in Molecular Weight Measurements of Low Molecular Weight Heparins by Gel Permeation Chromatography/Chromatographic system/Columns/Analytical: Change
guard column TSK SWXL 6-mm × 4-mm;
to:
guard column TSK SWXL 6-mm × 4-cm;

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 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 Analysis: Change
Result = (R_U/R_S) x C_S x V x (D/W_U) x (1/L) x 100
R_U = peak area ratio of ibuprofen to benzophenone from the Sample solution
R_S = peak area ratio of ibuprofen to benzophenone from the Standard solution
C_S = concentration of USP Ibuprofen RS in the Standard solution (mg/mL)
V = volume of Medium, 900 mL
D = density of Oral Suspension (g/mL)
W_U = weight of the portion of Oral Suspension added to the Medium (g)
L = label claim (mg/mL)
to:
Result = (R_U/R_S) x C_S x V x (d/W_U) x D x (1/L) x 100
R_U = peak area ratio of ibuprofen to benzophenone from the Sample solution
R_S = peak area ratio of ibuprofen to benzophenone from the Standard solution
C_S = concentration of USP Ibuprofen RS in the Standard solution (mg/mL)
V = volume of Medium, 900 mL
d = density of Oral Suspension (g/mL)
W_U = weight of the portion of Oral Suspension added to the Medium (g)
D = dilution factor of the Sample solution, 2
L = label claim (mg/mL)

In Standard solution B: Change
Before injection, pass through a membrane filter of 0.45-µL or finer pore size,
to:
Before injection, pass through a membrane filter of 0.45-µm or finer pore size,
AND
In Sample solution: Change
Before injection, pass through a membrane filter of 0.45-µL or finer pore size,
to:
Before injection, pass through a membrane filter of 0.45-µm or finer pore size,

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 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 Test A: Change
It responds to the Identification test under Penicillin G Benzathine Oral Suspension: the spot obtained from the test solution, corresponding in R_F value to that obtained from the Standard solution, is completely resolved from a second spot, produced by penicillin G procaine.
to:
Mix a portion of it with methanol to obtain a solution containing about 3000 Penicillin G Units per mL. Apply 20 µL of this test solution and 20 µL of a Standard solution of USP Penicillin G Benzathine RS in methanol containing 2.5 mg per mL to a suitable thin-layer chromatographic plate (see Chromatography 〈621〉) coated with a 0.25-mm layer of chromatographic silica gel, and allow the spots to dry. Using an unlined developing chamber, develop the chromatogram in a solvent system consisting of a mixture of methanol, acetonitrile, and ammonium hydroxide (70:30:3) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, and allow to air-dry. Spray the plate uniformly with a spray reagent prepared as follows. Dissolve 20 g of tartaric acid and 1.7 g of bismuth subnitrate in 80 mL of water. Add 2.5 mL of this solution, 2.5 mL of potassium iodide solution (4 in 10), and 10 g of tartaric acid to 50 mL of water, and mix. Examine the chromatograms: the principal spot obtained from the test solution corresponds in R_F value to that obtained from the Standard solution. The spot obtained from the test solution, corresponding in R_F value to that obtained from the Standard solution, is completely resolved from a second spot, produced by penicillin G procaine.

In USP Tryptophan Related Compound A RS: Change
3,3′-[Ethylidenebis(1H-indole-1,3-diyl)]bis[2S)-2-aminopropanoic]acid.
C₂₄H₂₆N₄O₄ 432.49
to:
(2S,2'S)-3,3'-[Ethane-1,1-diylbis(1H-indole-1,3-diyl)]bis(2-aminopropanoic acid).
C₂₄H₂₆N₄O₄ 434.50

Change
USP Atorvastatin Related Compound H RS (lactone impurity)
to:
USP Atorvastatin Related Compound H RS
Also known as Lactone impurity;
AND
Change
USP Atorvastatin Related Compound I RS (acetonide impurity)
to:
USP Atorvastatin Related Compound I RS
Also known as Acetonide impurity;

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 Acceptance criteria/Total impurities: Change
NMT 2.5%. Disregard any peak below 0.05% of the peak area of fluocinolone acetonide from the Standard solution.
to:
NMT 2.5%. Disregard any peak below 0.05% of the peak area of fluocinolone acetonide from the Sample solution.

Change
Where the label states tetracycline hydrochloride must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins are such that the requirement under the relevant dosage form monograph(s) in which tetracycline hydrochloride is used can be met.
to:
Where the label states Tetracycline Hydrochloride must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins are such that the requirement under the relevant dosage form monograph(s) in which Tetracycline Hydrochloride is used can be met.

In Analysis: Change
r_A = peak response of each saccharide degree of polymerization (DP₁–DP₃) in the Sample solution (If any peaks of DP₄ and above are observed in the sample, take the summation of all peak responses DP₄₊ and use this value as r_U.)
to:
r_A = peak response of each saccharide degree of polymerization (DP₁–DP₃) in the Sample solution (If any peaks of DP₄ and above are observed in the sample, take the summation of all peak responses DP₄₊ and use this value as r_A.)

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 Analysis: Change
r_S = sum of all the peaks except those each of which with an area less than 0.1 times the area of the major peak from the Reference solution
to:
r_T = sum of all the peaks except those each of which with an area less than 0.1 times the area of the major peak from the Reference solution

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

Change
2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimeth oxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate, pentamethylene ester
to:
2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate, pentamethylene ester

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)