Errata - English

Line 3 of Application/4.: Change
proscribed
to:
prescribed
AND
Line 3 of Description of Polymers Contained in <661.1>/Polyethylenes: Change
Low-density polypropylene (LDPE)
to:
Low-density polyethylene (LDPE)
AND
Line 6 of Description of Polymers Contained in <661.1>/Polypropylene: Change
0.3% polypropylene
to:
0.3%. Polypropylene
AND
Line 3 of Description of Polymers Contained in <661.1>/Polyethylene Terephthalate and Polyethylene Terephthalate G: Change
1,4-cyclohexaemimethanol
to:
1,4-cyclohexanedimethanol

Line 2 of USP Miconazole Related Compound C RS: Change
2-[(2,4-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethan-1-amine.
C₁₅H₁₃Cl₄NO 365.08
to:
2-[(2,4-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethan-1-amine hydrochloride.
C₁₅H₁₃Cl₄NO · HCl 401.53

In the second Calculate statement: Change
chloroindolinone and ziprasidone related compound F
to:
chloroindolinone, ziprasidone related compound F, and any individual unspecified impurity
AND
In the second variable definition list: Change
F = relative response factor for chloroindolinone or ziprasidone related compound F from Table 3
to:
F = relative response factor for chloroindolinone or ziprasidone related compound F or any individual unspecified impurity from Table 3

Line 2 of USP Eszopiclone Related Compound A RS:
[Note—This material may be available in the free base or salt form.]
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide.
C₁₇H₁₇ClN₆O₄ 404.81
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide, 3-chlorobenzoic salt (1:1).
C₁₇H₁₇ClN₆O₄ · C₇H₅ClO 561.38
to:
[Note—This material may be available in the free base or salt form.]
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide.
C₁₇H₁₇ClN₆O₄ 404.81
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide, 3-chlorobenzoate salt (1:1).
C₁₇H₁₇ClN₆O₄ · C₇H₅ClO₂ 561.38

Line 2 of USP Eszopiclone Related Compound A RS:
[Note—This material may be available in the free base or salt form.]
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide.
C₁₇H₁₇ClN₆O₄ 404.81
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide, 3-chlorobenzoic salt (1:1).
C₁₇H₁₇ClN₆O₄ · C₇H₅ClO 561.38
to:
[Note – This material may be available in the free base or salt form.]
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide.
C₁₇H₁₇ClN₆O₄ 404.81
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide, 3-chlorobenzoate salt (1:1).
C₁₇H₁₇ClN₆O₄ · C₇H₅ClO₂ 561.38

Line 2 of USP Argatroban Related Compound B RS: Change
Ethyl (2R,4R)-1-[N⁸-nitro-L-arginyl]-4-methylpiperidine-2-carboxylate hydrochloride.
C₁₅H₂₈N₆O₅ ∙ HCl 408.88
to:
Ethyl (4R)-1-[N⁸-nitro-L-arginyl]-4-methylpiperidine-2-carboxylate dihydrochloride.
C₁₅H₂₈N₆O₅ ∙ 2HCl 445.34

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
Add
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.]
AND
Line 1 of Procedure: Change
Proceed as directed for Procedure in the Assay under Diluted Isosorbide Dinitrate.
to:
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
Chewable Tablets respond to the Identification test under Isosorbide Dinitrate Tablets.
to:
Transfer a suitable quantity of finely powdered Tablets to a glass-stoppered centrifuge tube. Add 10 mL of sodium hydroxide solution (1 in 250), shake to wet the powder, then add 15 mL of solvent hexane, and again shake. Centrifuge the mixture, and transfer the upper phase to a beaker. Evaporate the solvent, and dry the residue in vacuum over anhydrous calcium chloride at room temperature for 16 hours: the IR absorption spectrum of a suitable solution in chloroform of the residue so obtained exhibits maxima only at the same wavelengths as that of a similar preparation from the residue obtained from USP Diluted Isosorbide Dinitrate RS.

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
Add
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.]
AND
Line 1 of Procedure: Change
Proceed as directed for Procedure in the Assay under Diluted Isosorbide Dinitrate.
to:
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
Tablets respond to the Identification test under Isosorbide Dinitrate Tablets.
to:
Transfer a suitable quantity of finely powdered Tablets to a glass-stoppered centrifuge tube. Add 10 mL of sodium hydroxide solution (1 in 250), shake to wet the powder, then add 15 mL of solvent hexane, and again shake. Centrifuge the mixture, and transfer the upper phase to a beaker. Evaporate the solvent, and dry the residue in vacuum over anhydrous calcium chloride at room temperature for 16 hours: the IR absorption spectrum of a suitable solution in chloroform of the residue so obtained exhibits maxima only at the same wavelengths as that of a similar preparation from the residue obtained from USP Diluted Isosorbide Dinitrate RS.

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
Add
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.]
AND
Line 1 of Procedure: Change
Proceed as directed for Procedure in the Assay under Diluted Isosorbide Dinitrate.
to:
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.

In the equation in Standardization: Change
N = mg K₂Cr₂O₇/49.04 x mL Na₂S₂O₃
to:
M = mg K₂Cr₂O₇/49.04 x mL Na₂S₂O₃

Line 4 of paragraph 3 of 3.2 Combined Validation of Accuracy and Precision: Change
validate evaluate
to:
validate
AND
Variable definition in paragraph 6 of 3.2 Combined Validation of Accuracy and Precision: Change
Z²(1 + P)/2 = standard normal
to:
Z²(1 + P)/2 = the square of the standard normal

Line 2 of USP Salmeterol Related Compound H RS: Change
1-Hydroxy-4-[2-hydroxy-5-(1-hydroxy-2-{[6-(4-phenylbutoxy)hexyl]amino}ethyl)benzyl]-2-naphthoic acid.
C₃₆H₄₃NO₆ 585.73
to:
1-Hydroxy-4-[2-hydroxy-5-(1-hydroxy-2-{[6-(4-phenylbutoxy)hexyl]amino}ethyl)benzyl]-2-naphthoic acid, monohydrate.
C₃₆H₄₃NO₆ · H₂O 603.76

Line 2 of USP Salmeterol Related Compound H RS: Change
1-Hydroxy-4-[2-hydroxy-5-(1-hydroxy-2-{[6-(4-phenylbutoxy)hexyl]amino}ethyl)benzyl]-2-naphthoic acid.
C₃₆H₄₃NO₆ 585.73
to:
1-Hydroxy-4-[2-hydroxy-5-(1-hydroxy-2-{[6-(4-phenylbutoxy)hexyl]amino}ethyl)benzyl]-2-naphthoic acid, monohydrate.
C₃₆H₄₃NO₆ · H₂O 603.76

Line 1 of C: Change
Undiluted Oral Rinse used as the test solution meets the requirements for Identification test B under Calcium Gluconate, except that a Standard solution containing about 0.6 mg of USP Potassium Gluconate RS per mL is used and 15 μL of the test solution and the Standard solution are applied to the thin-layer chromatographic plate.
to:
Use undiluted Oral Rinse as the test solution and prepare a Standard solution of USP Potassium Gluconate RS in water containing 0.6 mg/mL. Apply separate 15-μL portions of the test solution and the Standard solution to a suitable thin-layer chromatographic plate (see Chromatography <621>) coated with a 0.25-mm layer of chromatographic silica gel, and allow to dry. Develop the chromatogram in a solvent system consisting of a mixture of alcohol, water, ammonium hydroxide, and ethyl acetate (50:30:10:10) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, and dry at 110° for 20 minutes. Allow to cool and spray with a spray reagent prepared as follows. Dissolve 2.5 g of ammonium molybdate in about 50 mL of 2 N sulfuric acid in a 100-mL volumetric flask, add 1.0 g of ceric sulfate, swirl to dissolve, dilute with 2 N sulfuric acid to volume, and mix. Heat the plate at 110° for about 10 minutes: the principal spot obtained from the test solution corresponds in color, size, and R_F value to that obtained from the Standard solution.

Line 1 of Sample solution: Change
25 mg/mL of Norepinephrine Bitartrate in glacial acetic acid. If necessary warm slightly to effect solution.
to:
Dissolve 500 mg of Norepinephrine Bitartrate in 20 mL of glacial acetic acid, warming slightly if necessary to effect solution.

Footnote m: Change
(2S,5R,6R)-Ethyl 6-((R)-2-{(2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxopiperazine-1-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxamido}-2-phenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate.
to:
2-(((3-Acetyl-4-(ethoxycarbonyl)-5,5-dimethylthiazolidin-2-yl)methyl)amino)-2-oxo-1-phenylethyl 6-(2-(4-ethyl-2,3-dioxopiperazine-1-carboxamido)-2-phenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate.

Line 3 of Standard solution A: Change
lead acetate,
to:
lead acetate TS,
AND
Line 11 of Analysis: Change
Locate the two prominent bands from Standard solution A corresponding in R_F value to the two bands from Standard solution B.
to:
Locate the prominent bands from Standard solution A corresponding in R_F value to the band from Standard solution B.

Line 2 of USP Eszopiclone Related Compound A RS: Change
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide.
C₁₇H₁₇ClN₆O₄ 404.81
to:
[Note—This material may be available in the free base or salt form.]
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide.
C₁₇H₁₇ClN₆O₄ 404.81
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide, 3-chlorobenzoic salt (1:1).
C₁₇H₁₇ClN₆O₄ · C₇H₅ClO 561.38