Errata - English

Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside and dicaffeoylquinic acid/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower R_F) and chlorogenic acid (higher R_F) that are clearly separated,
to:
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher R_F) and chlorogenic acid (lower R_F) that are clearly separated,
AND
Line 3 of C.: Change
Standard solution B;
to:
Standard solution C;

Line 3 of A. Thin-Layer Chromatography/Presence of chicoric acid and absence of echinacoside/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower R_F) and chlorogenic acid (higher R_F) that are clearly separated,
to:
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher R_F) and chlorogenic acid (lower R_F) that are clearly separated,

Line 4 of A. HPTLC for Articles of Botanical Origin <203>/For Tablets containing Echinacea angustifolia Dry Extract/System suitability: Change
Standard solution B shows two major blue bands at about the middle section due to caftaric acid (lower R_F) and chlorogenic acid (higher R_F) that are clearly separated,
to:
Standard solution B shows two major blue bands at about the middle section due to caftaric acid (higher R_F) and chlorogenic acid (lower R_F) that are clearly separated,

Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside and dicaffeoylquinic acid/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower R_F) and chlorogenic acid (higher R_F) that are clearly separated,
to:
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher R_F) and chlorogenic acid (lower R_F) that are clearly separated,
AND
Line 3 of C.: Change
Standard solution B;
to:
Standard solution C;

Footnote e and f: Change
^e Methyl 7-chloro-6,7,8-trideoxy-6-[(2S,4R)-1-methyl-4-ethylpyrrolidine-2-carboxamido]-1-thio-L-threo-α-D-galacto-octopyranoside 3-phosphate.
^f Methyl 7-chloro-6,7,8-trideoxy-6-[(2S,4R)-1-methyl-4-propylpyrrolidine-2-carboxamido]-1-thio-D-threo-α-D-galacto-octopyranoside.
to:
^e Methyl 7-chloro-6,7,8-trideoxy-6-[(2S,4R)-1-methyl-4-propylpyrrolidine-2-carboxamido]-1-thio-L-threo-α-D-galacto-octopyranoside 3-phosphate.
^f Methyl 7-chloro-6,7,8-trideoxy-6-[(2S,4R)-1-methyl-4-propylpyrrolidine-2-carboxamido]-1-thio-L-threo-α-D-galacto-octopyranoside.

Line 5 of paragraph 1 of Robust Design During Development: Change
lamellae (46,47)
to:
lamellae as discussed in Evaluation of the Inner Surface Durability of Glass Containers <1660> and by the FDA (45)
AND
Line 2 of paragraph 4 of Robust Design During Development: Change
(ICH)-relevant trials.
to:
(ICH)-relevant trials (46).

Line 2 of USP Chlorpheniramine Related Compound C RS: Change
3-(4-Chlorophenyl-N-methyl-3-(pyridin-2-yl)propan-1-amine.
C₁₅H₁₇CIN₂ 260.76
to:
3-(4-Chlorophenyl)-N-methyl-3-(pyridin-2-yl)propan-1-amine maleate.
C₁₅H₁₇CIN₂ · C₄H₄O₄ 376.83

Line 2 of USP Irinotecan Related Compound C RS: Change
(S)-9-[(1,4′-Bipiperidine)-1′-carbonyloxy]-4-methyl-11-ethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1H-pyrano[3′,4′:6,7]indolizino[1,2-b]quinoline hydrochloride.
to:
11-Ethyl-4-hydroxy-4-methyl-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano[3′,4′:6,7]indolizino[1,2-b]quinolin-9-yl (1,4′-bipiperidine)-1′-carboxylate hydrochloride.

Line 2 of USP Chlorpheniramine Related Compound C RS: Change
3-(4-Chlorophenyl-N-methyl-3-(pyridin-2-yl)propan-1-amine.
C₁₅H₁₇CIN₂ 260.76
to:
3-(4-Chlorophenyl)-N-methyl-3-(pyridin-2-yl)propan-1-amine maleate.
C₁₅H₁₇CIN₂ · C₄H₄O₄ 376.83

In Acid stage/Analysis/variable definition list: Change
V = volume of Medium, 750 mL
to:
V = volume of Acid stage medium, 750 mL
AND
In Buffer stage/Analysis/variable definition list: Change
V = volume of Medium, 1000 mL
to:
V = volume of Buffer stage medium, 1000 mL

Line 2 of USP Almotriptan Related Compound D RS: Change
1-[({3-[2-(Dimethylamino)ethyl]indol-5-yl}methyl)sulfonyl]pyrrolidine N-oxide.
C₁₇H₂₅N₃O₃S 351.46
to:
1-[({3-[2-(Dimethylamino)ethyl]indol-5-yl}methyl)sulfonyl]pyrrolidine N-oxide hydrochloride.
C₁₇H₂₅N₃O₃S · HCl 387.92

Line 2 of USP Cilostazol Related Compound C RS: Change
1-(4-(5-Cyclohexyl-1H-tetrazol-1-yl)butyl)-6-(4-(1-cyclohexyl-1H-tetrazol-5-yl)butoxy)-3,4-dihydroquinolin-2(1H)-one.
C₃₁H₄₃N₉O₃ 589.73
to:
1-(4-(1-Cyclohexyl-1H-tetrazol-5-yl)butyl)-6-(4-(1-cyclohexyl-1H-tetrazol-5-yl)butoxy)-3,4-dihydroquinolin-2(1H)-one.
C₃₁H₄₅N₉O₂ 575.75

Line 4 of USP Almotriptan Related Compound B RS: Change
C₁₅H₂₂N₃O₂S
to:
C₁₅H₂₁N₃O₂S
AND
Line 2 of USP Almotriptan Related Compound D RS: Change
1-[({3-[2-(Dimethylamino)ethyl]indol-5-yl}methyl)sulfonyl]pyrrolidine N-oxide.
C₁₇H₂₅N₃O₃S 351.46
to:
1-[({3-[2-(Dimethylamino)ethyl]indol-5-yl}methyl)sulfonyl]pyrrolidine N-oxide hydrochloride.
C₁₇H₂₅N₃O₃S · HCl 387.92

Line 3 of Analysis: Change
Calculate the percentage of each specified impurity
to:
Calculate the percentage of each specified impurity, other than chloroquine related compound G,
AND
In Analysis/second equation/variable definition list: Change
r_U=peak response of chloroquine N-oxide or any other impurity from the Sample solution
r_U=peak response of chloroquine related compound G or any other impurity from the Sample solution

Change
Buffer solution, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Diluted Isosorbide Dinitrate.
to:
Buffer solution—Dissolve 15.4 g of ammonium acetate in water, add 11.5 mL of glacial acetic acid, dilute with water to 1000 mL, and mix to obtain a solution having a pH of about 4.7.
Mobile phase—Mix 350 mL of water, 100 mL of Buffer solution, and 550 mL of methanol. Cool to room temperature, dilute with water to 1000 mL, mix, degas, and filter. Make adjustments if necessary (see System Suitability under Chromatography <621>).
Internal standard solution—Transfer a quantity of diluted nitroglycerin to a suitable volumetric flask, add about 60% of the flask volume of methanol, sonicate for 5 minutes, and shake for 30 minutes. Dilute with methanol to volume to obtain a solution having a concentration of about 3 mg of nitroglycerin per mL, and mix. Allow any undissolved material to settle, filter, and store the filtrate in an airtight container.
Standard preparation—Transfer about 125 mg of recently mixed USP Diluted Isosorbide Dinitrate RS, accurately weighed, to a 50-mL volumetric flask, add about 30 mL of Mobile phase, shake for 30 minutes, dilute with Mobile phase to volume, and mix. Pipet 10 mL of the resulting solution into a 25-mL volumetric flask, and add 4.0 mL of Internal standard solution and 4 mL of dilute Buffer solution (1 in 10). Cool to room temperature, dilute with Mobile phase to volume, and mix to obtain a solution having a known concentration of about 0.25 mg of isosorbide dinitrate per mL, based on the quantity of USP Diluted Isosorbide Dinitrate RS weighed and the labeled content of isosorbide dinitrate. Pass a portion of this solution through a 0.45-µm filter.
AND
Change
Procedure—Proceed as directed for Procedure in the Assay under Diluted Isosorbide Dinitrate.
to:
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 220-nm detector and a 4-mm × 25-cm column that contains packing L1. The flow rate is about 1 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the resolution, R, between isosorbide dinitrate and nitroglycerin is not less than 2.0; and the relative standard deviation for replicate injections determined from the peak response ratios is not more than 2%. [NOTE—The relative retention times are about 0.75 for isosorbide dinitrate and 1.0 for nitroglycerin. The relative retention times for isosorbide mononitrates, if present, are about 0.38.]
Procedure—Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.

Line 2 of USP Mycophenolate Mofetil Related Compound B RS: Change
(RS)-7-Hydroxy-5-methoxy-4-methyl-6-[2-(5-methyl-2-oxo-tetrahydrofuran-5-yl)ethyl]-3H-isobenzofuranyl-1-one.
to:
(RS)-7-Hydroxy-5-methoxy-4-methyl-6-[2-(5-methyl-2-oxo-tetrahydrofuran-5-yl)ethyl]-3H-isobenzofuran-1-one.

Line 1: Change
Buffer solution and Mobile phase—Prepare as directed in the Assay under Diluted Isosorbide Dinitrate.
to:
Buffer solution and Mobile phase—Prepare as directed in the Assay.
AND
Line 1 of Chromatographic system: Change
(see Chromatography <621>)—Proceed as directed in the Assay under Diluted Isosorbide Dinitrate.
to:
(see Chromatography <621>)—Proceed as directed in the Assay.