Errata - English

In paragraph 2 of 2.4 Study Design/2.4.1 Time Points: Change
Assessment of Drug Product Performance—Bioavailability, Bioequivalence, and Dissolution 〈1090〉.
to:
Assessment of Solid Oral Drug Product Performance and Interchangeability, Bioavailability, Bioequivalence, and Dissolution 〈1090〉.

In the equation in Analysis: Change
Result = (r_U/r_T) x 100
to:
Result = (r_U/r_T) x D x 100
AND
Add
D = dilution factor for the Sample solution, 0.01

In Procedure: Change
20,000(C_S)(r_i/r_S)(1/F)
in which C_S is the concentration, in mg per mL, of orbifloxacin in the Standard solution; r_i is the peak area response for each impurity obtained from the Test solution; r_S is the peak area response for the orbifloxacin peak obtained from the Standard solution; and F is the relative response factor for each impurity, as presented in Table 1.
to:
20,000(C_S)(r_i/r_S)(1/F)(1/W)
in which C_S is the concentration, in mg per mL, of orbifloxacin in the Standard solution; r_i is the peak area response for each impurity obtained from the Test solution; r_S is the peak area response for the orbifloxacin peak obtained from the Standard solution; F is the relative response factor for each impurity, as presented in Table 1; and W is the sample weight taken to prepare the Test solution (mg).

Change
Mix a quantity of Oral Suspension, equivalent to about 200 mg of mebendazole, with 20 mL of a mixture of chloroform and 96 percent formic acid (19:1). Proceed as directed for Identification under Mebendazole Tablets, beginning with “Warm the suspension on a water bath for a few minutes.” The specified result is obtained.
to:
Mix a quantity of Oral Suspension, equivalent to about 200 mg of mebendazole, with 20 mL of a mixture of chloroform and 96 percent formic acid (19:1). Warm the suspension on a water bath for a few minutes, cool, and filter through a medium-porosity, sintered-glass filter. Apply 10 μL of this solution and 10 μL of a Standard solution of USP Mebendazole RS in a mixture of chloroform and 96 percent formic acid (19:1) containing 10 mg per mL to a suitable thin-layer chromatographic plate (see Chromatography <621>) coated with a 0.25-mm layer of chromatographic silica gel mixture. Allow the spots to dry, and develop the chromatogram in a solvent system consisting of a mixture of chloroform, methanol, and 96 percent formic acid (90:5:5) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, mark the solvent front, allow the solvent to evaporate, and examine the plate under short-wavelength UV light: the R_F value of the principal spot obtained from the Test solution corresponds to that obtained from the Standard solution.

In USP Reference Standards <11>/USP Mirtazapine Resolution Mixture RS: Change
This resolution mixture contains approximately 0.1% w/w each of the following:
Impurity A: 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine 2-oxide.
to:
Mirtazapine.
Impurity A: 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine 2-oxide.

In USP Reference Standards <11>/USP Mirtazapine Resolution Mixture RS: Change
This resolution mixture contains approximately 0.1% w/w each of the following:
Impurity A: 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine 2-oxide.
to:
Mirtazapine.
Impurity A: 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine 2-oxide.

In the Standard solution: Change
Transfer suitable volumes of the Standard stock solution and Internal standard solution into a suitable volumetric flask and dilute with Diluent to volume.
to:
0.1 mg/mL of USP Tiagabine Hydrochloride RS and 0.04 mg/mL of butylparaben in Diluent prepared as follows. Transfer suitable volumes of the Standard stock solution and Internal standard solution into a suitable volumetric flask and dilute with Diluent to volume.
AND
In the Sample solution: Change
Transfer suitable volumes of the Sample stock solution and Internal standard solution into a suitable volumetric flask and dilute with Diluent to volume.
to:
0.1 mg/mL of Tiagabine Hydrochloride and 0.04 mg/mL of butylparaben in Diluent prepared as follows. Transfer suitable volumes of the Sample stock solution and Internal standard solution into a suitable volumetric flask and dilute with Diluent to volume.

In the footnotes in Table 2: Change
^d(S,E)-6-Chloro-4-(pent-3-en-1-ynyl)-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one.
^e(S,Z)-6-Chloro-4-(pent-3-en-1-ynyl)-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one.
to:
^d(S,Z)-6-Chloro-4-(pent-3-en-1-ynyl)-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one.
^e(S,E)-6-Chloro-4-(pent-3-en-1-ynyl)-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one.

In USP Atorvastatin Related Compound C RS: Change
Difluoro impurity, or (3R,5R)-7-[3-(phenylcarbamoyl)-4,5-bis(4-fluorophenyl)-2-isopropyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
to:
Calcium (3R,5R)-7-[2,3-Bis(4-fluorophenyl)-5-isopropyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate (1:2); Also known as Difluoro impurity, or (3R,5R)-7-[3-(phenylcarbamoyl)-4,5-bis(4-fluorophenyl)-2-isopropyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
AND
In USP Atorvastatin Related Compound D RS: Change
Epoxide impurity, or 3-(4-fluorobenzoyl)-2-isobutyryl-3-phenyl-oxirane-2-carboxylic acid phenylamide.
to:
3-(4-Fluorobenzoyl)-2-isobutyryl-N,3-diphenyloxirane-2-carboxamide; Also known as Epoxide impurity, or 3-(4-fluorobenzoyl)-2-isobutyryl-3-phenyl-oxirane-2-carboxylic acid phenylamide.
AND
In USP Atorvastatin Related Compound E RS: Change
3S,5S Enantiomer, or (3S,5S)-7-[3-(phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
C₆₆H₆₈CaF₂N₄O₁₀ 1155.34
to:
Calcium (3S,5S)-7-[2-(4-Fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate (1:2); Also known as 3S,5S Enantiomer, or (3S,5S)-7-[3-(phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
C₆₆H₆₈CaF₂N₄O₁₀ 1155.38
AND
In USP Atorvastatin Related Compound H RS: Change
540.62
to:
540.64
AND
In Atorvastatin Related Compound I RS: Change
654.81
to:
654.82

Change
Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species:
to:
Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli:

In In-Process Controls/paragraph 2: Change
Refer to Risk Assessment for discussion on critical process parameters (CPP).
to:
Refer to Quality Systems for discussion on critical process parameters (CPP).
AND
In Final Product Release Specifications/Dose-Defining Assays/paragraph 3: Change
relay
to:
rely

In Heavy Metals, Total Terephthaloyl Moieties, and Ethylene Glycol/Extracting media: Change
50 percent alcohol: Dilute 125 mL of alcohol with water to 238 mL, and mix.
25 percent alcohol: Dilute 125 mL of 50 percent alcohol with water to 250 mL, and mix.
General procedure: [Note— Use an Extracting medium of 50 percent alcohol for PET bottles and 25 percent alcohol for PETG bottles.]
to:
Purified Water: See monograph.
50 percent alcohol: Dilute 125 mL of alcohol with water to 238 mL, and mix.
25 percent alcohol: Dilute 125 mL of 50 percent alcohol with water to 250 mL, and mix.
n-Heptane
General procedure: [Note— Use an Extracting medium of 50 percent alcohol for PET bottles and 25 percent alcohol for PETG bottles.]
AND
In four instances in Heavy Metals, Total Terephthaloyl Moieties, and Ethylene Glycol/Heavy Metals: Change
Extracting media
to:
Purified Water Extracting medium
AND
In Heavy Metals, Total Terephthaloyl Moieties, and Ethylene Glycol/Ethylene Glycol/Test solution: Change
Extracting media
to:
Purified Water Extracting medium
AND
In Heavy Metals, Total Terephthaloyl Moieties, and Ethylene Glycol/Ethylene Glycol/Procedure/paragraph 1: Change
Extracting media extract Extracting medium
to:
Purified Water Extracting medium
AND
In Heavy Metals, Total Terephthaloyl Moieties, and Ethylene Glycol/Ethylene Glycol/Procedure/paragraph 2: Change
using as the blank the solution from the Extracting media: the absorbance of the solution
to:
using Purified Water Extracting medium as the blank: the absorbance of the solution

In paragraph 3: Change
Upon completion of each ignition, cover the crucible, and allow it to cool in a desiccator to room temperature before weighing.
to:
Upon completion of each ignition, cover the crucible, and allow it to cool in a desiccator to room temperature before weighing accurately.

In Acceptance criteria/Chromatographic similarity: Change
[Note—The chromatogram of the Standard is similar to the reference chromatogram provided with the lot of being used.]
to:
[Note—The chromatogram of the Standard is similar to the reference chromatogram provided with the lot of USP Anise Oil RS being used.]

In three instances in Analysis: Change
0.1 M sodium hydroxide
to:
Titrant
AND
In the equation: Change
M
to:
N
AND
In the variable definition list: Change
M = actual molarity of the Titrant (mol/L)
to:
N = actual normality of the Titrant

In USP Galantamine Hydrobromide Related Compounds Mixture RS: Change
Anhydrogalantamine;
(4aS,8aS)-3-Methoxy-11-methyl-9,10,11,12-tetrahydro-4aH-benzo[2,3]benzofuro[4,3-cd]azepine.
C₁₇H₁₉NO₂
to:
Anhydrogalantamine;
(4aS,8aS)-3-Methoxy-11-methyl-9,10,11,12-tetrahydro-4aH-benzo[2,3]benzofuro[4,3-cd]azepine.
C₁₇H₁₉NO₂ 269.34

Change
Phenothiazin-5-ium, 3,7-bis(dimethylamino)-, chloride;
3,7-Bis(dimethylamino)phenothiazin-5-ium chloride;
to:
Phenothiazin‐5‐ium, 3,7‐bis(dimethylamino)‐, chloride, hydrate (1:1:x);
3,7‐Bis(dimethylamino)phenothiazin‐5‐ium chloride hydrate;
[122965‐43‐9].
AND
Change
Monohydrate [122965-43-9].
to:
Monohydrate [67183‐68‐0].