Errata - English

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 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.

In the first variable definition list in Analysis: Change
C_S = concentration of USP Clotrimazole RS in the Clotrimazole stock solution (mg/mL)
to:
C_S = concentration of USP Clotrimazole RS in the Standard solution (mg/mL)
AND
In the second variable definition list in Analysis: Change
C_S = concentration of USP Betamethasone Dipropionate RS in the Betamethasone dipropionate stock solution (mg/mL)
to:
C_S = concentration of USP Betamethasone Dipropionate RS in the Standard solution (mg/mL)

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)

Row 4 of Column 1 of Procedure 1/Impurity Table 1:Change
Efavirenz pent-3-ene-1-yne (cis)^c
to:
Efavirenz pent-3-ene-1-yne (trans)^c
AND
Row 5 of Column 1 of Procedure 1/Impurity Table 1:Change
Efavirenz pent-3-ene-1-yne (trans)^d
to:
Efavirenz pent-3-ene-1-yne (cis)^d
AND
Row 3 of Column 1 of Procedure 2/Impurity Table 2: Change
Efavirenz pent-3-ene-1-yne (cis)^a
to:
Efavirenz pent-3-ene-1-yne (trans)^a
AND
Row 4 of Column 1 of Procedure 2/Impurity Table 2:Change
Efavirenz pent-3-ene-1-yne (trans)^b
to:
Efavirenz pent-3-ene-1-yne (cis)^b

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 16 of Analysis: Delete
Calculate the percentage of any unspecified impurity in the portion of Tetracycline Hydrochloride taken:
Result = (r_U/r_S) × (C_S/C_U) × 100
r_U = peak response of any unspecified impurity from the Sample solution
r_S = peak response of tetracycline from the Standard solution
C_S = concentration of USP Tetracycline Hydrochloride RS in the Standard solution (µg/mL)
C_U = concentration of Tetracycline Hydrochloride in the Sample solution (µg/mL)

Line 6 of Analysis: Change
Result_i = (r_i/r_s) × C_s × [M × (M_r1/M_r2)] × V x (1/L) × 100
to:
Result_i = (r_i/r_s) × C_s × [M × (M_r1/M_r2)] × D × V × (1/L) × 100
AND
To the variable definition list in Analysis: Add
D = dilution factor of the Sample solution

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 Promethazine Related Compound B RS: Change
Isopromethazine;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine.
C₁₇H₂₀N₂S 284.42
to:
Isopromethazine hydrochloride;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine hydrochloride.
C₁₇H₂₀N₂S · HCl 320.88

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 Promethazine Related Compound B RS: Change
Isopromethazine;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine.
C₁₇H₂₀N₂S 284.42
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

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

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 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 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 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 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 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 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 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 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 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 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

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

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.