Errata - English

Line 2 of USP Ropivacaine Related Compound B RS: Change
(R)-ropivacaine hydrochloride monohydrate; (R)-(−)-1-propylpiperidine-2-carboxylic acid (2,6-dimethylphenyl)-amide hydrochloride monohydrate.
to:
(R)-Ropivacaine hydrochloride monohydrate; (R)-(+)-1-propylpiperidine-2-carboxylic acid (2,6-dimethylphenyl)-amide hydrochloride monohydrate.

Line 6 of Analysis: Change
Rinse the condenser with two 10-mL portions of 70% alcohol, add phenolphthalein TS,
to:
Rinse the condenser with 10 mL of 70% alcohol, followed by three 10-mL portions of water, collecting the rinsings in the flask. Cool, rinse the sides of the flask with two 10-mL portions of 70% alcohol, add phenolphthalein TS,

Line 15 of Analysis: Change
methotrexate related compound E free acid
to:
methotrexate related compound E free base
AND
Line 8 of the second variable definition list for Analysis: Change
methotrexate related compound E free acid
to:
methotrexate related compound E free base
AND
Row 5 of Column 1 of Impurity Table 1: Change
Methotrexate related compound E free acid^c
to:
Methotrexate related compound E free base^c

Line 1: Change
Dissolve an accurately weighed quantity of Tetracaine Hydrochloride for Injection in water to obtain a test solution containing 50 mg per mL, and proceed as directed in the test for Chromatographic purity under Tetracaine, beginning with “Prepare a Standard solution.”
to:
Dissolve an accurately weighed quantity of Tetracaine Hydrochloride for Injection in water to obtain a test solution containing 50 mg per mL. Prepare a Standard solution of 4-(butylamino) benzoic acid in methanol containing 0.2 mg per mL. Apply separate 5-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 mixture. Develop the plate in a suitable chromatographic chamber containing a solvent system consisting of a mixture of chloroform, methanol, and isopropylamine (98:7:2) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, and dry in a current of warm air. Examine the plate under short-wavelength UV light: any spot obtained from the test solution, other than the principal spot, is not more intense than the principal spot obtained from the Standard solution (0.4%), and the sum of the intensities of any such spots is not greater than 0.8%.

A paragraph before the Introduction was deleted:
This chapter provides guidance and procedures used for characterization of biotechnology-derived articles by polyacrylamide gel electrophoresis. Portions of the chapter that are not harmonized with the other two pharmacopeias are marked by the symbol ♦. This chapter is harmonized with the corresponding chapter in JP and EP. Other characterization tests, also harmonized, are shown in Biotechnology-Derived Articles—Amino Acid Analysis <1052>, Biotechnology-Derived Articles—Capillary Electrophoresis <1053>, Biotechnology-Derived Articles—Isoelectric Focusing <1054>, Biotechnology-Derived Articles—Peptide Mapping <1055>, and Biotechnology-Derived Articles—Total Protein Assay <1057>.

Line 6 of Analysis: Change
Result = (r_U/r_S) × (C_S/C_U) × P × (1/F) ×100
to:
Result = (r_U/r_S) × (C_S/C_U) × P × F × 100

Line 1 of A: Change
It responds to Identification test B under Tetracaine Hydrochloride.
to:
Dissolve 100 mg in 10 mL of water, and add 1 mL of potassium thiocyanate solution (1 in 4): a crystalline precipitate is formed. Recrystallize the precipitate from water, and dry at 80° for 2 hours: it melts between 130° and 132°.

Line 3 of the variable definition list: Change
r_S = peak response of each impurity from the Standard solution
to:
r_S= peak response of each impurity or doxazosin mesylate (for calculating unspecified impurities) from the Standard solution
AND
Line 5 of the variable definition list: Change
C_S = concentration of USP Doxazosin Mesylate RS in the Standard solution (mg/mL)
to:
C_S= concentration of the corresponding USP Doxazosin Related Compound RS or USP Doxazosin Mesylate RS (for calculating unspecified impurities) in the Standard solution (mg/mL)

Change the subsection
Standard solution: 5 µg/mL of USP Metolazone RS in methanol
to:
Standard stock solution: 0.25 mg/mL of USP Metolazone RS in methanol
Standard solution: 5 µg/mL of USP Metolazone RS in Mobile phase from Standard stock solution
AND
Line 2 of Sample solution: Change
of metolazone from the Sample stock solution in methanol
to:
of metolazone in Mobile phase from the Sample stock solution

Line 1 of B: Change
It responds to Identification test B under Tetracaine Hydrochloride.
to:
Dissolve 100 mg in 10 mL of water, and add 1 mL of potassium thiocyanate solution (1 in 4): a crystalline precipitate is formed. Recrystallize the precipitate from water, and dry at 80° for 2 hours: it melts between 130° and 132°.

Line 5 of Analysis: Change
Result = 100(r_A + r_B) × W_IS × (SA_(corr) × W)
to:
Result = 100(r_A + r_B) × W_IS/(S_A(corr) × W)
AND
Line 12 of Analysis: Change
SA_(corr)
to:
S_A(corr)

Footnote 2: Change
http://whqlibdoc.who.int/trs/WHO_TRS_917_annex2.pdf (Accessed June 30, 2011)
to:
http://who.int/medicines/areas/quality_safety/quality_assurance/GoodtradeDistributionPracticesTRS917Annex2.pdf?ua=1 (Accessed March 2, 2015)

Line 10 of Analysis: Change
A = 100 mm divided by the length of the polarimeter tube (mm)
to:
A = 100 divided by the length of the polarimeter tube (dm)
AND
Line 21 of Analysis: Change
A = 100 mm divided by the length of the polarimeter tube (mm)
to:
A = 100 divided by the length of the polarimeter tube (dm)

Line 1 of Procedure: Change
Proceed as directed for Procedure in the Assay under Cromolyn Sodium Inhalation Solution.
to:
Concomitantly determine the absorbances of the Standard preparation and the Assay preparation in 1-cm cells at the wavelength of maximum absorbance at about 326 nm, with a suitable spectrophotometer, using a 1 in 100 aqueous solution of pH 7.4 Sodium phosphate buffer as the blank. Calculate the quantity, in mg, of C₂₃H₁₄Na₂O₁₁ in each mL of the Ophthalmic Solution taken by the formula:
(C/V)(A_U/A_S)
in which C is the concentration, in µg per mL, of USP Cromolyn Sodium RS in the Standard preparation; V is the volume, in mL, of Ophthalmic Solution taken; and A_U and A_S are the absorbances of the solutions obtained from the Assay preparation and the Standard preparation, respectively.

Line 10 of the Calculate statement in the Analysis: Change
C_U = nominal concentration of cefotaxime sodium in Sample solution 1, 2, 3, or 4 (mg/mL)
to:
C_U = nominal concentration of cefotaxime in Sample solution 1, 2, 3, or 4 (mg/mL)

Line 2 of Procedure 2: Change
Buffer, Solution A, Solution B, Mobile phase, System suitability solution, and Chromatographic system:
to:
Buffer, Solution A, Solution B, Mobile phase, System suitability solution, Chromatographic system, and System suitability:

Footnote 11: Delete
http://www.fda.gov/ForIndustry/ImportProgram/AdmissibilityDeterminationsforShipmentsofForeign-originOASIS/ucm077691.htm (Accessed June 6, 2011).

Line 7 of Analysis: Change
Result = (R_U/R_S) × (C_S/C_U) × P × F × 100
to:
Result = (R_U/R_S) × (C_S/C_U) × P × 100
AND
Line 17 of Analysis: Change
P = potency of cefadroxil in USP Cefadroxil RS (µg/mg)
to:
P = potency of cefazolin in USP Cefazolin RS (mg/mg)
AND
Line 19 of Analysis: Delete
F = conversion factor, 0.001 mg/µg