Errata - English

Line 1 of Identification test A: Change
A volume of Injection diluted, if necessary, with water to obtain a test solution of calcium gluconate (1 in 100) responds to Identification test B under Calcium Gluconate.
to:
Dissolve a quantity of it in water to obtain a test solution containing 10 mg per mL, heating in a water bath at 60° if necessary. Similarly, prepare a Standard solution of USP Potassium Gluconate RS in water containing 10 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, and allow to dry.Develop the chromatogram in a solvent system consisting of a mixture of alcohol, water, ammonium hydroxide, and ethyl acetate (50: 30: 10: 10) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, and dry at 110° for 20 minutes. Allow to cool, spray with a spray reagent prepared as follows. Dissolve 2.5 g of ammonium molybdate in about 50 mL of 2 N sulfuric acid in a 100-mL volumetric flask, add 1.0 g of ceric sulfate, swirl to dissolve, dilute with 2 N sulfuric acid to volume, and mix. Heat the plate at 110° for about 10 minutes: the principal spot obtained from the test solution corresponds in color, size, and R_F value to that obtained from the Standard solution.

Line 2 of USP Levalbuterol Related Compound H RS: Change
4-[2-(tert-Butylamino)-1-methoxyethyl]-2-(hydroxymethyl)phenol.
C₁₄H₂₃NO₃ 253.34
to:
4-[2-(tert-Butylamino)-1-methoxyethyl]-2-(hydroxymethyl)phenol acetate.
C₁₄H₂₃NO₃ · C₂H₄O₂ 313.39

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

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 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)

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 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 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°.

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 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 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%.

Line 1 of footnote 2: Change
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3B_R2/Step4/Q3B_R2_Guideline.pdf.
to:
http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html.

Line 4 of Procedure: Change
Calculate the percentage, on the anhydrous and solvent-free basis, of C₁₄H₂₂N₆O₅ · HCl
to:
Calculate the percentage of valganciclovir hydrochloride (C₁₄H₂₂N₆O₅ · HCl)
AND
Line 8 of Procedure: Change
100[(r_U / W_U)(C_F )(100) /(100 − S_U)]
to:
100[(r_U/W_U)(C_F)(100)]
AND
Line 12 of Procedure: Change
C_F is the correction factor; and S_U is the total percent of solvent and water in the test sample.
to:
and C_F is the correction factor.
AND
Line 16 of Procedure: Change
(W_S / R_S)[(100 − S_S) /100]
to:
(W_S/R_S)/100
AND
Line 18 of Procedure: Change
R_S is the area response (sum of two peaks for valganciclovir diastereomers) obtained from the Standard preparation; and S_S is the total percent of solvent and water in USP Valganciclovir Hydrochloride RS.
to:
and R_S is the area response (sum of two peaks for valganciclovir diastereomers) obtained from the Standard preparation.

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 2 of bullet 1 of International Regulations and Guidance Documents in second paragraph: Change
http://www.emea.europa.eu/pdfs/human/bwp/026895en.pdf
to:
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003684.pdf
AND
Line 2 of bullet 2 of International Regulations and Guidance Documents in second paragraph: Change
http://www.emea.europa.eu/pdfs/human/bwp/179302en.pdf
to:
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/WC500003675.pdf
AND
Line 3 of bullet 3 of International Regulations and Guidance Documents in second paragraph: Change
http://www.emea.europa.eu/pdfs/vet/iwp/074300en.pdf
to:
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004575.pdf
AND
Delete bullet 4 of International Regulations and Guidance Documents in second paragraph
AND
Line 2 of bullet 5 of International Regulations and Guidance Documents in second paragraph: Change
http://www.emea.europa.eu/pdfs/human/bwp/TSE%20NFG%20410-rev2.pdf
to:
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003712.pdf
AND
Line 1 of bullet 6 of International Regulations and Guidance Documents in second paragraph: Change
Terrestrial animal health code 2007. Available at http://www.oie.int/eng/normes/mcode/code2007/anc-en_summary.htm.
to:
Terrestrial animal health code. Available at http://www.oie.int/doc/ged/D10905.pdf.

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