Errata - English

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 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.)

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 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 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 Analysis: Change
C_S = concentration of USP Prazosin Hydrochloride RS in the Standard solution (µg/mL)
C_U = nominal concentration of prazosin in the Sample solution (µg/mL)
M_r1 = molecular weight of prazosin, 383.41
M_r2 = molecular weight of prazosin hydrochloride, 419.86
to:
C_S = concentration of USP Prazosin Hydrochloride RS in the Standard solution (mg/mL)
C_U = nominal concentration of prazosin in the Sample solution (mg/mL)
M_r1 = molecular weight of prazosin, 383.41
M_r2 = molecular weight of prazosin hydrochloride, 419.87

In Content of Proanthocyanidins/Standard stock solution: Change
USP Procyanidin A₂ RS
to:
USP Procyanidin A2 RS
AND
In Content of Proanthocyanidins/Analysis: Change
Use the absorbance recorded for Standard solutions 1–5 to obtain a calibration curve (absorbance vs. concentration, in µg/mL, of procyanidin A₂) and perform a linear regression analysis. Determine the concentration (C), in µg/mL, of total proanthocyanidins as procyanidin A₂ in the Sample solution.
to:
Use the absorbance recorded for Standard solutions 1–5 to obtain a calibration curve (absorbance vs. concentration, in µg/mL, of procyanidin A2) and perform a linear regression analysis. Determine the concentration (C), in µg/mL, of total proanthocyanidins as procyanidin A2 in the Sample solution.
AND
In Content of Proanthocyanidins/Analysis: Change
C = concentration of the Sample solution as procyanidin A₂ from the regression line (µg/mL)
to:
C = concentration of the Sample solution as procyanidin A2 from the regression line (µg/mL)
AND
In Content of Proanthocyanidins/Acceptance criteria: Change
procyanidin A₂
to:
procyanidin A2

Change
847.00
to:
847.02
AND
Change
(9S,12E,14S,15R,16S,17R,18R,19R,20S,21S,22E,24Z)-6,16,18,20-Tetrahydroxy-1′-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethylspiro[9,4-(epoxypentadeca[1,11,13]trienimino)-2H-furo[2′,3′:7,8]naphth[1,2-d]imidazole-2,4′-piperidine]-5,10,26-(3H,9H)-trione-16-acetate
to:
(9S,12E,14S,15R,16S,17R,18R,19R,20S,21S,22E,24Z)-6,18,20-Trihydroxy-1’-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethyl-5,10,26-trioxo-3,5,9,10-tetrahydrospiro[9,4-(epoxypentadeca[1,11,13]trienimino)-2H-furo[2’,3’:7,8]naphtho[1,2-d]imidazole-2,4’-piperidin]-16-yl acetate

Change
523.32
to:
523.33
AND
Change
(3R)-3-Amino-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl-4-(2,4,5-trifluorophenyl)butan-1-one phosphate monohydrate
to:
(3R)-3-Amino-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-4-(2,4,5-trifluorophenyl)butan-1-one phosphate monohydrate

In Test 2/Analysis: Change
C_S = concentration of USP Prazosin Hydrochloride RS in the Standard solution (µg/mL)
to:
C_S = concentration of USP Prazosin Hydrochloride RS in the Standard solution (mg/mL)
AND
Change
M_r2 = molecular weight of prazosin hydrochloride, 419.86
to:
M_r2 = molecular weight of prazosin hydrochloride, 419.87

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 B.: Change
The retention time of the major peak of the Sample solution exhibits maxima and minima at the same wavelengths as those of the Standard solution, as obtained in the Assay.
to:
The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

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 Dissolution 〈711〉/Medium: Change
26.7 g/L of sodium acetate trihydrate in water. Add 133 mL of glacial acetic acid to this solution, and then dilute with water to 10 L; 900 mL.
to:
0.02 M sodium acetate buffer, pH 3.5, prepared as follows. Dissolve 2.67 g of sodium acetate in 100 mL of water. Add 13.3 mL of glacial acetic acid and then dilute with water to 1000 mL; 900 mL.

In General Pharmacopeial Requirements/Pesticide Residues: Change
where L is the limit in the original article as listed in Table 4 (see Pesticide Residue Analysis under Articles of Botanical Origin <561>)
to:
where L is the limit in the original article as listed in Table 5 (see Pesticide Residue Analysis under Articles of Botanical Origin <561>)

In Test 1, Test 3, Test 4, Test 5, and Test 6/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 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 Analysis: Change
Calculate the percentage of Nandrolone Decanoate (C₂₈H₄₄O₃) in the portion of Nandrolone Decanoate taken:
to:
Calculate the percentage of nandrolone decanoate (C₂₈H₄₄O₃) in the portion of Nandrolone Decanoate taken:

In USP Reference Standards 〈11〉: Change
USP Rivastigmine Tartrate R-Isomer RS
to:
USP Rivastigmine Tartrate R-Isomer RS
(R)-3-[1-(Dimethylamino)ethyl]phenyl ethylmethylcarbamate, hydrogen tartrate.
C₁₄H₂₂N₂O₂ · C₄H₆O₆ 400.42

In Test 2/Analysis: Change
C_S = concentration of USP Norethindrone Acetate RS (mg/mL) or USP Ethinyl Estradiol RS (ug/mL) in the Standard solution
to:
C_S = concentration of USP Norethindrone Acetate RS (mg/mL) or USP Ethinyl Estradiol RS (µg/mL) in the Standard solution

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 Dissolution 〈711〉/Standard solution: Change
USP Dapsone RS of a known concentration in Medium
to:
(L/1000) mg/mL of USP Dapsone RS in Medium, where L is the label claim in mg/Tablet. Transfer a portion of this solution containing 0.2 mg of dapsone to a 25-mL volumetric flask, add 5 mL of 1 N sodium hydroxide, and dilute with water to volume.