Errata - English

Line 2 of USP Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C₆H₁₀N₄O 154.17
to:
Theophyllidine;
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride monohydrate.
C₆H₁₀N₄O · HCl · H₂O 208.65

Line 2 of paragraph 1 of Operational Qualification: Change
OQ demonstrates fitness for the selected use, and should reflect the contents of the DQ document.
to:
OQ demonstrates fitness for the selected use, and should reflect URS.
AND
Line 2 of paragraph 3 of Operational Qualification/Instrument Function Tests: Change
Holistic tests, which involve the entire system, demonstrate that the whole system complies with user specifications in the DQ.
to:
Holistic tests, which involve the entire system, demonstrate that the whole system complies with URS.

Line 2 of USP Brinzolamide Related Compound B RS: Change
(R-4-Amino)-2,3-dihydro-2-(3-methoxypropyl)-4H-thieno[3,2,-e]-thiazine-6-sulfonamide-1,1-dioxide ethandioate 1:1.
to:
(R)-4-Amino-2-(3-methoxypropyl)-3,4-dihydro-2H-thieno[3,2-e][1,2]thiazine-6-sulfonamide 1,1-dioxide oxalate.

Line 5 of Analysis: Change
Result = (r_U/r_S) × (C_S/C_U) × (M_r1/M_r2) × 100
to:
Result = (r_U/r_S) × (C_S/C_U) × 100
AND
Line 14 of Analysis: Delete
M_r1=molecular weight of anhydrous entecavir, 277.28
M_r2=molecular weight of entecavir, 295.29

Line 2 of USP Promethazine Related Compound B RS: Change
Isopromethazine;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine.
C₁₇H₂₀N₂S 282.42
to:
Isopromethazine hydrochloride;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine hydrochloride.
C₁₇H₂₀N₂S · HCl 320.88

Line 3 of USP Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C₆H₁₀N₄O 154.17
to:
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride monohydrate.
C₆H₁₀N₄O · HCl · H₂O 208.65

In the variable definition list in Analysis: Change
C_S = concentration of USP Clotrimazole Related Compound A RS in the Clotrimazole related compound A stock solution (mg/mL)
to:
C_S = concentration of USP Clotrimazole Related Compound A RS in the Standard solution (mg/mL)

Line 2 of USP Promethazine Related Compound B RS: Change
Isopromethazine;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine.
C₁₇H₂₀N₂S 282.42
to:
Isopromethazine hydrochloride;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine hydrochloride.
C₁₇H₂₀N₂S · HCl 320.88

Line 2 of USP Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C₆H₁₀N₄O 154.17
to:
Theophyllidine;
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride monohydrate.
C₆H₁₀N₄O · HCl · H₂O 208.65

Line 2 of USP Brinzolamide Related Compound B RS: Change
(R-4-Amino)-2,3-dihydro-2-(3-methoxypropyl)-4H-thieno[3,2,-e]-thiazine-6-sulfonamide-1,1-dioxide ethandioate 1:1.
to:
(R)-4-Amino-2-(3-methoxypropyl)-3,4-dihydro-2H-thieno[3,2-e][1,2]thiazine-6-sulfonamide 1,1-dioxide oxalate.

Line 1 of Physicochemical Tests/Acidity or Alkalinity/BRP indicator solution: Change
1.0 mg/mL of bromophenol blue,
to:
1.0 mg/mL of bromothymol blue,
AND
Line 3 of Plastic Additives/Polyethylene, Cyclic Olefins, and Polypropylene/Phenolic Antioxidants/Test B: Change
tris(2,4-di-tert-butylphenyl) phosphate;
to:
tris(2,4-di-tert-butylphenyl) phosphite;
AND
Line 1 of Plastic Additives/Polyethylene, Cyclic Olefins, and Polypropylene/Phenolic Antioxidants/Test C/Mobile phase: Change
(55:45:5, v/v/v)
to:
(50:45:5, v/v/v)
AND
Line 1 of Plastic Additives/Polyethylene, Cyclic Olefins, and Polypropylene/Nonphenolic Antioxidants/Chromatographic system/Application: Change
20 µL of Sample solution S10, reference solution (o) and the reference solutions corresponding to
to:
20 µL of Sample solution S10 and the reference solutions corresponding to
AND
Line 2 of Plastic Additives/Plasticized Polyvinyl Chloride/USP Reference Standards <11>/USP Plastic Additive 05 RS: Change
Tris(2,4-di-tert-butylphenyl) phosphate.
to:
Tris(2,4-di-tert-butylphenyl) phosphite.  

Line 14 of Analysis: Change
M_r1 = molecular weight of betaxolol hydrochloride, 343.89
M_r2 = molecular weight of betaxolol, 307.43
to:
M_r1 = molecular weight of betaxolol, 307.43
M_r2 = molecular weight of betaxolol hydrochloride, 343.89

Line 1 of Procedure: Change
Proceed as directed for Procedure in the test for Related glycosides under Digoxin, except to omit the use of the Gitoxin standard solution.
to:
Apply 10 µL of the Test solution and 10 µL of the Standard solution on a line parallel to and about 2.5 cm from the bottom edge of a reversed-phase thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture to which is permanently bonded octadecylsilane (C18). Allow the spots to dry, and place the plates in a developing chamber containing a mixture of methanol and water (7:3). Develop the chromatogram until the solvent front has moved about 15 cm above the line of application. Remove the plate, and allow the solvent to evaporate. Spray the plate with Chloramine T–trichloroacetic acid reagent, freshly mixed, and heat in an oven at 110° for 10 minutes.

Line 2 of USP Ciprofloxacin Ethylenediamine Analog RS: Change
7-(2-Aminoethylamino)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid.
C₁₅H₁₆FN₃O₃ 305.30
to:
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[(2-aminoethyl)amino]-3-quinolinecarboxylic acid hydrochloride.
C₁₅H₁₆FN₃O₃ · HCl 341.77

Line 1: Change
It responds to Identification tests B and C under Succinylcholine Chloride.
to:
A. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
B. Thin-Layer Chromatographic Identification Test <201>
Standard solution: 1 mg/mL of USP Succinylcholine Chloride RS in water
Sample solution: Nominally 1 mg/mL of succinylcholine chloride from Injection in water
Chromatographic system
(See Chromatography <621>, Thin-Layer Chromatography.)
Adsorbent: 0.25-mm layer of chromatographic silica gel
Application volume: 1 µL
Developing solvent system: Acetone and 1 N hydrochloric acid (1:1)
Analysis
Samples: Standard solution and Sample solution
Proceed as directed in the chapter. To locate the spots, heat the plate at 105° for 5 min, cool, and spray with potassium bismuth iodide TS, then heat again at 105° for 5 min.
Acceptance criteria: Meets the requirements

Footnote c: Change
(4R,4aS,5aR,12aS)-4-Dimethylamino-3,10,12,12a-tetrahydroxy-7-methylamino-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide.
to:
(4S,4aS,5aR,12aS)-4-Dimethylamino-3,10,12,12a-tetrahydroxy-7-methylamino-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide.

Line 3: Change
Mobile phase: Alcohol and 0.05 M monobasic sodium phosphate, adjusted with phosphoric acid to a pH of 2.7 (5:95)
to:
Buffer: 0.05 M monobasic sodium phosphate, adjusted with phosphoric acid to a pH of 2.7
Mobile phase: Alcohol and Buffer (5:95)

Line 1 of Procedure: Change
Proceed as directed for Procedure in the test for Related glycosides under Digoxin, except to omit the use of the Gitoxin standard solution.
to:
Apply 10 µL of the Test solution and 10 µL of the Standard solution on a line parallel to and about 2.5 cm from the bottom edge of a reversed-phase thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture to which is permanently bonded octadecylsilane (C18). Allow the spots to dry, and place the plates in a developing chamber containing a mixture of methanol and water (7:3). Develop the chromatogram until the solvent front has moved about 15 cm above the line of application. Remove the plate, and allow the solvent to evaporate. Spray the plate with Chloramine T–trichloroacetic acid reagent, freshly mixed, and heat in an oven at 110° for 10 minutes.

Line 2 of USP Ciprofloxacin Ethylenediamine Analog RS: Change
7-(2-Aminoethylamino)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid.
C₁₅H₁₆FN₃O₃ 305.30
to:
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[(2-aminoethyl)amino]-3-quinolinecarboxylic acid hydrochloride.
C₁₅H₁₆FN₃O₃ · HCl 341.77

Line 1 of Procedure: Change
Proceed as directed for Procedure in the test for Related glycosides under Digoxin, except to omit the use of the Gitoxin standard solution.
to:
Apply 10 µL of the Test solution and 10 µL of the Standard solution on a line parallel to and about 2.5 cm from the bottom edge of a reversed-phase thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture to which is permanently bonded octadecylsilane (C18). Allow the spots to dry, and place the plates in a developing chamber containing a mixture of methanol and water (7:3). Develop the chromatogram until the solvent front has moved about 15 cm above the line of application. Remove the plate, and allow the solvent to evaporate. Spray the plate with Chloramine T–trichloroacetic acid reagent, freshly mixed, and heat in an oven at 110° for 10 minutes.

Change
Microbial Enumeration Tests <2021>: The total bacterial count does not exceed 10⁴ cfu/g. The total combined molds and yeasts count does not exceed 1000 cfu/g. It meets the requirements of the tests for absence of Salmonella species and Escherichia coli.
to:
Microbial Enumeration Tests <2021>: The total bacterial count does not exceed 10⁴ cfu/g. The total combined molds and yeasts count does not exceed 10³ cfu/g.
Absence of Specified Microorganisms <2022>: Meets the requirements of the tests for absence of Salmonella species and Escherichia coli

Line 16 of Analysis: Change
Calculate the percentage of any individual unspecified impurity
to:
Calculate the percentage of any other individual impurity
AND
Line 20 of Analysis: Change
r_U = peak response of any individual unspecified impurity
to:
r_U = peak response of any other individual impurity

Line 2 of USP Cyclobenzaprine Related Compound B RS: Change
3-(5H-Dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-1-propanamine.
C₁₉H₁₉N 261.36
to:
3-(5H-Dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-1-propanamine hydrochloride.
C₁₉H₁₉N · HCl 297.82

Line 5 of Type A1 (formerly, Type A): Change
radionucleotides
to:
radionuclides
AND
Line 5 of Type A2 (formerly, Type B3): Change
radionucleotides
to:
radionuclides
AND
Line 5 of Type B1: Change
radionucleotides
to:
radionuclides
AND
Line 5 of Type B2 (total exhaust): Change
radionucleotides
to:
radionuclides