Errata - English

In Liquid Chromatography: Isocratic Elution/Injection volume: Change
Result = (V_inj2 = V_inj1 (L₂ d_c2² )/(L₁ d_c1²)
to:
V_inj2 = V_inj1 (L₂ d_c2² )/(L₁ d_c1²)
AND
In Liquid Chromatography: Gradient Elution/Column parameters and flow rate: Change
F₂ = F₂ × [(dc₂² × dp₁)/(dc₁² × dp₂)]
to:
F₂ = F₁ × [(dc₂² × dp₁)/(dc₁² × dp₂)]

In USP Melengestrol Acetate Related Compound A RS: Change
16-Methylene-17α-hydroxy-4-pregnene-3,20-dione 17-acetate.
to:
16-Methylene-3,20-dioxopregn-4-en-17-yl acetate.
AND
In USP Melengestrol Acetate Related Compound B RS: Change
17α-Hydroxy-6,16-dimethyleneprogna-4-ene-3,20-dione 17-acetate.
to:
6,16-Dimethylene-3,20-dioxopregn-4-en-17-yl acetate.

Change
541.68
Milbemycin B, 5-O-demethyl-28-deoxy-25-methyl-6,28-epoxy-23-hydroxyimino-, [6R,23S,25S(E)]-; (2αE,4E,5′S,6R,6′S,8E,11R,13R,15S,17αR,20αR,20βS)-3′,4′,5′,6,6′,7,10,11,14,15,17α,20,20α,20β-tetradecahydro-20β-hydroxy-5′,6′,6,8,19-pentamethylspiro[11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2′-[2H]pyran]-17-one 20-oxime.
to:
541.69
Milbemycin B, 5-demethoxy-28-deoxy-6,28-epoxy-5-(hydroxyamino)-25-methyl-, (6R,25R)-; (2R,2a′E,2a1′S,4′E,5S,6R,6′R,8′E,11′R,15′S,17a′R,20′Z,20a′R)-2a1′-Hydroxy-20′-(hydroxyimino)-5,6,6′,8′,19′-pentamethyl-2a1′,3,4,5,6,6′,7′,10′,11′,14′,15′,17a′,20′,20a′-tetradecahydro-2′H,17′H-spiro[pyran-2,13′-[11,15]methano[1,5]dioxacyclooctadecino[9,8,7-cd]benzofuran]-17′-one.
AND
Change
555.70
Milbemycin B, 5-O-demethyl-28-deoxy-25-ethyl-6,28-epoxy-23-hydroxyimino-, [6R,23S,25S(E)]-; (2αE,4E,5′S,6R,6′S,8E,11R,13R,15S,17αR,20αR,20βS)-6′-ethyl-3′,4′,5′,6,6′,7,10,11,14,15,17α,20,20α,20β-tetradecahydro-20β-hydroxy-5′,6,8,19-tetramethylspiro[11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2′-[2H]pyran]-17-one 20-oxime.
to:
555.71
Milbemycin B, 5-demethoxy-28-deoxy-6,28-epoxy-25-ethyl-5-(hydroxyamino)-, [6R,25R]-; (2R,2a′E,2a1′S,4′E,5S,6R,6′R,8′E,11′R,15′S,17a′R,20′Z,20a′R)-6-Ethyl-2a1′-hydroxy-20′-(hydroxyimino)-5,6′,8′,19′-tetramethyl-2a1′,3,4,5,6,6′,7′,10′,11′,14′,15′,17a′,20′,20a′-tetradecahydro-2′H,17′H-spiro[pyran-2,13′-[11,15]methano[1,5]dioxacyclooctadecino[9,8,7-cd]benzofuran]-17′-one.

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 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 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
Prepare Lidocaine, Racepinephrine, and Tetracaine Hydrochlorides Compounded Topical Gel containing 40 mg/mL of lidocaine hydrochloride, 1 mg/mL of racepinephrine hydrochloride, and 10 mg/mL of tetracaine hydrochloride as follows (see Pharmaceutical Compounding—Sterile Preparations <797>).
to:
Prepare Lidocaine, Racepinephrine, and Tetracaine Hydrochlorides Compounded Topical Gel containing 40 mg/mL of lidocaine hydrochloride, 1 mg/mL of racepinephrine hydrochloride, and 10 mg/mL of tetracaine hydrochloride as follows (see Pharmaceutical Compounding—Nonsterile Preparations <795>).

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.

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
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 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 Analysis: Change
C_U = nominal concentration of dimenhydrinate in the Sample solution (mg/mL)
to:
C_U = determined concentration of dimenhydrinate in the Sample solution, as obtained in the Assay (mg/mL)

Change
Where tetracycline hydrochloride must be sterile or subjected to further processing during the preparation of injectable dosage forms to ensure acceptable levels of bacterial endotoxins, it is so labeled.
to:
Where Tetracycline Hydrochloride must be sterile or subjected to further processing during the preparation of injectable dosage forms to ensure acceptable levels of bacterial endotoxins, it is so labeled.

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

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 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

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 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 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