Errata - English

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 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 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 Fenoldopam Related Compound A RS: Change
1-Methyl-3-benzazepine-7,8-diol, 6-chloro-2,3,4,5-tetrahydro-1-(4-hydroxyphenyl)-, methanesulfonate (salt).
C₁₇H₁₈ClNO₃ · CH₄SO₃ 415.89
to:
6-Chloro-1-(4-hydroxyphenyl)-3-methyl-2,3,4,5-tetrahydro-1H-benzo[d]azepine-7,8-diol hydrochloride
(N-Methyl-6-chloro-2,3,4,5-tetrahydro-1-(4-hydroxyphenyl)-1H-3-benzazepine-7,8-diol hydrochloride).
C₁₇H₁₉ClNO₃ · HCl 356.24

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 underChromatography <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.

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 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.

Change footnotes
^dEthyl 5-benzoyl-1-methylbenzimidazol-2-ylcarbamate.
^eMethyl 5-(4-toluoyl)-1-methylbenzimidazol-2-ylcarbamate.
to:
^dEthyl (5-benzoyl-1H-benzimidazol-2-yl)carbamate.
^eMethyl 5-(4-toluoyl)-1H-benzimidazol-2-ylcarbamate.

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 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 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 2 of USP Candesartan Cilexetil Related Compound D RS: Change
1-{[(Cyclohexyloxycarbonyloxy)carbonyl]oxy}ethyl 3-{[2’-(2-ethyl-2H-tetrazol-5-yl)biphenyl-4-yl]methyl}-2-oxo-2,3-dihydro-1H-benzimidazole-4-carboxylate.
to:
1-{[(Cyclohexyloxy)carbonyl]oxy}ethyl 3-({2’-(2-ethyl-2H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl}methyl)-2-oxo-2,3-dihydro-1H-benzimidazole-4-carboxylate.

Footnote b:Change
5-Methoxy-1-[4-(trifluoromethyl)phenyl]-1-pentanone (E)-O-[2-[(2-succinyl)amino]ethyl]oxime.
to:
(E)-5-Methoxy-1-[4-(trifluoromethyl)phenyl]-1-pentanone O-[2-[(2-succinyl)amino]ethyl]oxime.
AND
Footnotes c– g: Delete the space before oxime

Line 1 of Chromatographic system/Column: Change
10-µm
to:
5-µm
AND
In the variable definition list in Analysis: Change
r_U = citrate peak area from the Sample solution
r_S = citrate peak area from the Standard solution
to:
r_U = citric acid peak area from the Sample solution
r_S = citric acid peak area from the Standard solution
AND
Change
M_r2 = molecular weight of citrate (C₆H₅O₇), 189.10
to:
M_r2 = molecular weight of citric acid (C₆H₈O₇), 192.13

Line 1 of the variable definition list: Change
r_U = peak response of any impurity from the Sample solution
r_S = peak response of rocuronium bromide from the Dilute standard solution
to:
r_U = peak response of 2-propanol from the Sample solution
r_S = peak response of 2-propanol from the Dilute standard solution

Line 1 of Vitamin A, Method 1/Sample solution: Change
Sample solution
to:
Sample stock solution
AND
Line 23 of Sample solution: Change
Dilute a volume of this solution
to:
Sample solution: Dilute a volume of the Sample stock solution
AND
Line 1 of Cholecalciferol or Ergocalciferol (Vitamin D), Method 1/Sample solution:Change
Proceed as directed for the Sample solution
to:
Proceed as directed for the Sample stock solution
AND
Line 1 of Vitamin E, Method 1/Sample solution: Change
Proceed as directed for the Sample solution
to:
Proceed as directed for the Sample stock solution
AND
Line 1 of Phytonadione/Sample solution:Change
Proceed as directed for the Sample solution
to:
Proceed as directed for the Sample stock solution

Line 1 of Vitamin A, Method 1/Sample solution: Change
Sample solution
to:
Sample stock solution
AND
Line 16 of Sample solution: Change
Dilute a 10-mL volume of this solution
to:
Sample solution: Dilute a 10-mL volume of the Sample stock solution
AND
Line 2 of Cholecalciferol or Ergocalciferol (Vitamin D), Method 1/Sample solution: Change
Proceed as directed for the Sample solution
to:
Proceed as directed for the Sample stock solution
AND
Line 1 of Vitamin E, Method 1/Sample solution: Change
Proceed as directed for the Sample solution
to:
Proceed as directed for the Sample stock solution
AND
Line 2 of Phytonadione, Method 1/Sample solution: Change
retained as specified in the directions for Sample solution
to:
retained as specified in the directions for Sample stock solution

Line 1 of Vitamin A/Sample solution: Change
Sample solution
to:
Sample stock solution
AND
Line 21 of Sample solution: Change
Further dilute this solution
to:
Sample solution: Dilute the Sample stock solution
AND
Line 2 of Vitamin D/Sample solution: Change
as directed for the Sample solution
to:
as directed for the Sample stock solution
AND
Line 2 of Vitamin E/Sample solution: Change
prepared as directed for the Sample solution
to:
prepared as directed for the Sample stock solution
AND
Line 2 of Phytonadione (Vitamin K₁):Change
as directed for the Sample solution
to:
as directed for the Sample stock solution
AND
Line 2 of Beta Carotene/Sample solution: Change
as directed for the Sample solution
to:
as directed for the Sample stock solution

Line 1 of Vitamin A/Sample solution: Change
Sample solution
to:
Sample stock solution
AND
Line 15 of Sample solution: Change
Further dilute this solution
to:
Sample solution: Dilute the Sample stock solution
AND
Line 2 of Vitamin D/Sample solution: Change
as directed for the Sample solution
to:
as directed for the Sample stock solution
AND
Line 2 of Vitamin E/Sample solution: Change
prepared as directed for the Sample solution
to:
prepared as directed for the Sample stock solution
AND
Line 2 of Phytonadione (Vitamin K₁):Change
as directed for the Sample solution
to:
as directed for the Sample stock solution
AND
Line 2 of Beta Carotene/Sample solution: Change
as directed for the Sample solution
to:
as directed for the Sample stock solution

Line 1 of Vitamin A, Method 1/Sample solution: Change
Sample solution
to:
Sample stock solution
AND
Line 23 of Sample solution: Change
Dilute a volume of this solution
to:
Sample solution: Dilute a volume of the Sample stock solution
AND
Line 1 of Cholecalciferol or Ergocalciferol (Vitamin D), Method 1/Sample solution:Change
Proceed as directed for the Sample solution
to:
Proceed as directed for the Sample stock solution
AND
Line 1 of Vitamin E, Method 1/Sample solution: Change
Proceed as directed for the Sample solution
to:
Proceed as directed for the Sample stock solution
AND
Line 2 of Phytonadione/Sample solution:Change
in the directions for the Sample solution
to:
in the directions for the Sample stock solution