Errata - English

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 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

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.

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.

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 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 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 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.

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 2 of Phytonadione/Sample solution:Change
in the directions for the Sample solution
to:
in the directions for the 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, 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
prepared as directed for the Sample solution
to:
prepared as directed for the Sample stock solution
AND
Line 2 of Vitamin E, Method 1/Sample solution: Change
prepared as directed for the Sample solution
to:
prepared as directed for the Sample stock solution
AND
Line 2 of Phytonadione, Method 1/Sample solution: Change
prepared as directed for the Sample solution
to:
prepared as directed for the Sample stock solution

Line 1 of Dissolution <711>/Analysis:Change
Determine the labeled amount of acetaminophen
to:
Determine the percentage of the labeled amount of acetaminophen
AND
In the second Calculate statement in Uniformity of Dosage Units <905>/Procedure for content uniformity/Analysis: Change
Calculate the quantity, in mg/mL, of the labeled amount of codeine phosphate
to:
Calculate the quantity, in mg, of codeine phosphate

The version of the Timolol Maleate monograph which appeared in the Second Supplement to USP 40–NF 35 did not include the revisions approved in the version appearing in the First Supplement to USP 40–NF 35. The version appearing in the First Supplement should be used. The file as it should have appeared in the Second Supplement is attached to the compendial notice found at http://www.uspnf.com/notices/second-supplement-usp-40-nf-35-online-timolol-maleate.

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

Line 1 of Dissolution <711>/Analysis:Change
Determine the labeled amount of acetaminophen
to:
Determine the percentage of the labeled amount of acetaminophen
AND
In the Calculate statement of Uniformity of Dosage Units <905>/Procedure for content uniformity/Analysis: Change
Calculate the quantity, in mg, of the labeled amount of codeine phosphate
to:
Calculate the quantity, in mg, of codeine phosphate

Line 1 of Sample solution: Change
Transfer 3.0 mL of the clear filtrate, reserved from the Assay, to a 100-mL volumetric flask.
to:
Sample stock solution: Dilute the clear filtrate, reserved from the Assay, with water to obtain a solution containing about 160 µg/mL of potassium citrate monohydrate.
Sample solution: Transfer 3.0 mL of the Sample stock solution to a 100-mL volumetric flask.

Line 1 of Standard solution: Change
Standard solution: 1.0 mg/mL each of five polyethylene glycol standards with molecular weights of 1000,2000, 3000, 4000, and 6000 g/mol (Da) in Mobilephase. Pass a portion of the solution
to:
Standard solutions: Prepare 1.0 mg/mL each of five polyethylene glycol standards with molecular weights of 1000,2000, 3000, 4000, and 6000 g/mol (Da) in Mobilephase separately in five individual flasks. Pass a portion of each solution
AND
Line 1 of Analysis/Samples: Change
Standard solution and Sample solution
to:
Standard solutions and Sample solution
AND
Line 3 of Analysis: Change
Separately inject equal volumes of the Standard solution
to:
Separately inject equal volumes of the Standard solutions

Line 1 of Sample solution: Change
1 mg/mL of Oral Suspension in Diluent
to:
Nominally 1 mg/mL of phenytoin prepared as follows. Weigh and transfer a suitable volume of Oral Suspension to an appropriate volumetric flask. Add methanol to about 20% of the final flask volume and dissolve. Dilute with Diluent to volume. Dissolve with the aid of sonication, if necessary.

Footnote c of Table 2: Change
(2aR,4R,4aS,9S,11S,12S,12aR,12bS)-1,2a,3,4,4a,6,9,10,11,12,12a,12b-Dodecahydro-4, 9,11,12,12b-pentahydroxy-4a,8,13,13-tetramethyl-7,11-methano-5H-cyclodeca[3,4]benz[1,2-b]oxet-5,6-dione 12b-acetate, 12-benzoate, 9-ester with (2R,3S)-N-formyl-3-phenylisoserine.
to:
(2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)‐12b‐Acetoxy‐9‐(((2R,3S)‐3‐formamido‐2‐hydroxy‐3‐phenylpropanoyl)oxy)‐4,6,11‐trihydroxy‐4a,8,13,13‐tetramethyl‐5‐oxo‐2a,3,4,4a,5,6,9,10,11,12,12a,12b‐dodecahydro‐1H‐7,11‐methanocyclodeca[3,4]benzo[1,2‐b]oxet-12‐yl benzoate.
AND
Footnote d of Table 2: Change
(2aR,4R,4aS,6R,9S,11S,12S,12aR,12bS)-6-{[(2,2-Dichloroethoxy)carbonyl]oxy}-1,2a,3,4,4a,6,9,10,11,12,12a,12b-dodecahydro-4,9,11,12,12b-pentahydroxy-4a,8,13,13-tetramethyl-7,11-methano-5H-cyclodeca[3,4]benz[1,2-b)oxet-5-one 12b-acetate, 12-benzoate, 9-ester with (2R,3S)-N-tert-butoxycarbonyl-e-phenylisoserine.
to:
(2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)‐6‐{[(2,2‐Dichloroethoxy)carbonyl]oxy}‐1,2a,3,4,4a,6,9,10,11,12,12a,12b‐dodecahydro‐4,9,11,12,12b‐pentahydroxy‐4a,8,13,13‐tetramethyl‐7,11‐methano‐5H‐cyclodeca[3,4]benz[1,2‐b]oxet‐5‐one 12b‐acetate, 12‐benzoate, 9‐ester with (2R,3S)‐N‐tert-butoxycarbonyl‐3‐phenylisoserine.

Line 2: Change
proceed as directed in the test for Delivered Dose Uniformity in Metered-Dose Inhalers and Dry Powder Inhalers, as described in <601>,
to:
proceed as directed in Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests <601>, A. Delivered-Dose Uniformity/A.2 Inhalation Aerosols and Inhalation Sprays and A.4 Inhalation Powders,
AND
Line 4: Delete
Unless otherwise stated in the individual monograph, apply the acceptance criteria for Metered-Dose Inhalers and Dry Powder Inhalers as described in <601>.