Errata - English

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 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 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 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

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 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 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 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

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.]

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].

Change
A solution or suspension of 1 or more Capsules in water responds to the test for Radionuclide identification under Sodium Iodide I 123 Solution.
to:
(see Radioactivity <821>)
The gamma-ray spectrum of a solution or suspension of 1 or more Capsules in water is identical to that of a specimen of ¹²³I of known purity that exhibits a major photoelectric peak having an energy of 0.159 MeV.

Change
pH 6.0 buffer, Mobile phase, Diluent, Standard preparation, Resolution solution, and Chromatographic system—Proceed as directed in the Assay under Carteolol Hydrochloride.
to:
Buffer, Mobile phase, Standard stock solution, Standard solution, System suitability stock solution, System suitability solution, Chromatographic system, and System suitability—
Proceed as directed in the Assay under Carteolol Hydrochloride.
AND
Add
Diluent—Prepare a mixture of Buffer and methanol (1:1).
AND
In all instances in Procedure: Change
Standard preparation
to:
Standard solution

Change
Other requirements
A solution or suspension prepared by homogenizing 1 or more Capsules in water to yield a concentration of not less than 1 MBq (25 µCi) per mL meets the requirements of the Assay for radioactivity under Sodium Iodide I 123 Solution.
to:
Assay for radioactivity
Prepare a solution or suspension by homogenizing 1 or more Capsules in water to yield a concentration of not less than 1 MBq (25 µCi) per mL. Determine the radioactivity of the resulting solution using a suitable counting assembly, by use of a calibrated system as directed under Radioactivity <821>.

Change
A solution or suspension of 1 or more Capsules in water responds to the test for Radionuclidic purity under Sodium Iodide I 123 Solution.
to:
(see Radioactivity <821>)
Using a suitable counting assembly, determine the radionuclidic purity of a solution or suspension of 1 or more Capsules in water: not less than 90% of the total radioactivity is present as I 123.

Change
Mobile phase, Internal standard solution, and Standard preparation—Prepare as directed in the Assay under Theophylline.
to:
Buffer solution—Transfer 2.72 g of sodium acetate trihydrate to a 2000-mL volumetric flask, add about 200 mL of water, and shake until dissolution is complete. Add 10.0 mL of glacial acetic acid, dilute with water to volume, and mix.
Mobile phase—Transfer 70.0 mL of acetonitrile to a 1000-mL volumetric flask, dilute with Buffer solution to volume, and mix. Degas, and filter before using. Make adjustments if necessary (see System Suitability under Chromatography <621>).
Internal standard solution—Transfer about 50 mg of theobromine, accurately weighed, to a 100-mL volumetric flask, dissolve in 10.0 mL of 6 N ammonium hydroxide, dilute with Mobile phase to volume, and mix.
Standard preparation—Dissolve an accurately weighed quantity of USP Theophylline RS in Mobile phase, and dilute quantitatively, and stepwise if necessary, with Mobile phase to obtain a solution having a known concentration of about 1 mg per mL. Transfer 10.0 mL of this solution to a 100-mL volumetric flask, add 20.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix to obtain a solution having a known concentration of about 0.1 mg of USP Theophylline RS per mL.
AND
Change
Chromatographic system—Proceed as directed in the Assay under Theophylline.
to:
(see Chromatography <621>)—The liquid chromatograph is equipped with a 280-nm detector and a 4-mm × 30-cm column that contains packing L1. The flow rate is about 1.0 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the resolution, R, between the theophylline and theobromine peaks is not less than 2.0, the tailing factor for the theophylline peak is not more than 2.0, and the relative standard deviation for replicate injections is not more than 1.5%.
AND
Change
Procedure—Proceed as directed for Procedure in the Assay under Theophylline.
to:
Procedure—Separately inject equal volumes (between 10 µL and 25 µL) of the Standard preparation and the Assay preparation into the chromatograph, and measure the peak responses for the major peaks. The retention time of theophylline relative to that of theobromine is about 1.6.