Errata - English

Line 5 of Analysis: Change
Result = (A_U/A_S) × C_S × d × V × D × (1/L) × 100
to:
Result = (A_U/A_S) × C_S × (d/W_U) × V × D × (1/L) × 100
AND
Add to the variable definition list
W_U = weight of reconstituted Cefdinir for Oral Suspension taken (mg)

Line 1: Change
Transfer an accurately measured volume of Injection, equivalent to about 1 g of mannitol as determined by the Assay, to a 100-mL volumetric flask:it meets the requirements of the test for Specific rotation under Mannitol.
to:
+137° to +145°.Transfer an accurately measured volume of Injection, equivalent to about 1 g of mannitol as determined by the Assay, to a 100-mL volumetric flask. Add 40 mL of a 1-in-10 ammonium molybdate solution, previously filtered if necessary. Add 20 mL of 1 N sulfuric acid, and dilute with water to volume.

Line 3: Change
As a minimum, the analytical procedure should be assessed by performing the repeatability test in any of the conditions previously mentioned (totaling 12 measurements).
to:
As a minimum, the analytical procedure should be assessed by performing the repeatability test in any combination of at least two of the conditions previously mentioned (totaling 12 measurements).

Line 3 of Sample stock solution: Change
Transfer the thimble to a continuous-extraction apparatus fitted with a 250-mL round-bottom flask containing 150 mL of hexane, and heat the flask on a heating mantle for 4 h. After the extraction, detach the round-bottom flask from the extraction apparatus, and discard the hexane. Dry the extraction thimble to remove residual hexane,
to:
Transfer the thimble to a continuous-extraction apparatus fitted with a 250-mL round-bottom flask containing 150 mL of solvent hexane, and heat the flask on a heating mantle for 4 h. After the extraction, detach the round-bottom flask from the extraction apparatus, and discard the solvent hexane. Dry the extraction thimble to remove residual solvent hexane,

Line 2 of Buffer, Mobile phase, Chromatographic system, and System suitability: Change
Proceed as directed in the Assay.
to:
Proceed as directed in the Assay, except use 270 nm for analysis.
AND
Line 10 of Analysis: Change
V = volume of the Medium, 750 mL
to:
V = volume of the Medium, 900 mL

Line 1 of Single-Dose (see also Injections <1>, Containers for Injections): Change
A single-unit package for an article intended for parenteral administration. Examples of single-dose containers include prefilled syringes, cartridges, fusion-sealed containers, and closure-sealed containers when so labeled.
to:
A single-unit package for an article intended for parenteral administration. A single-dose container is labeled as such. Examples of single-dose containers include prefilled syringes, cartridges, fusion-sealed containers, and closure-sealed containers when so labeled.

Line 3: Change
Calculate the percentage of any individual unspecified degradation product
to:
Calculate the percentage of any individual degradation product
AND
Line 6: Change
r_U = peak response of any individual unspecified degradation product from the Sample solution
to:
r_U = peak response of any individual degradation product from the Sample solution

Line 1 of Acceptance criteria: Change
The Sample may turn hazy, but it remains colorless, or shows a slight pink or yellow color, and the Sample does not become darker than the Standard solution.
to:
The oil portion of the Sample may turn hazy, but it remains colorless or shows a slight pink or yellow color, and the acid portion of the Sample does not become darker than the Standard solution.

Line 3 of Sample stock solution: Change
Transfer the thimble to a continuous-extraction apparatus fitted with a 250-mL round-bottom flask containing 150 mL of hexane, and heat the flask on a heating mantle for 4 h. After the extraction, detach the round-bottom flask from the extraction apparatus, and discard the hexane. Dry the extraction thimble to remove residual hexane,
to:
Transfer the thimble to a continuous-extraction apparatus fitted with a 250-mL round-bottom flask containing 150 mL of solvent hexane, and heat the flask on a heating mantle for 4 h. After the extraction, detach the round-bottom flask from the extraction apparatus, and discard the solvent hexane. Dry the extraction thimble to remove residual solvent hexane,

Line 13 of paragraph 2 of C.3 Apparatus 2 for Inhalation Powders—Marple Miller Impactor/C.3.1 Design—Apparatus 2: Change
Adjust the timer controlling the operation of the two-way solenoid valve so that it opens this valve for a duration of T seconds as determined during testing for Delivered-Dose Uniformity.
to:
Adjust the timer controlling the operation of the two-way solenoid valve so that it opens this valve for a duration such that the total volume sampled is at least 4 L.
AND
Line 3 of paragraph 2 of C.4 Apparatus 3 for Inhalation Powders—Andersen Impactor (with pre-separator)/C.4.1 Design—Apparatus 3: Change
Once the product is positioned, discharge the powder into the apparatus by activating the timer and opening the two-way solenoid valve for the required duration, T ± 5%, as determined during testing for Delivered-Dose Uniformity.
to:
Once the product is positioned, discharge the powder into the apparatus by activating the timer and opening the two-way solenoid valve for the required duration such that the total volume sampled is at least 4 L.
AND
Line 19 of paragraph 2 of C.5 Apparatus 4 for Inhalation Powders—Multistage Liquid Impinger/C.5.1 Design—Apparatus 4: Change
Adjust the timer controlling the operation of the two-way solenoid valve so that it opens the valve for the same duration, T, as used during testing for Delivered-Dose Uniformity.
to:
Adjust the timer controlling the operation of the two-way solenoid valve so that it opens the valve for the duration such that the total volume sampled is at least 4 L.
AND
Line 9 of paragraph 4 of C.6 Apparatus 5 for Inhalation Powders—Next Generation Impactor (with pre-separator)/C.6.2 Procedure—Apparatus 5: Change
Adjust the timer controlling the operation of the two-way solenoid valve so that it opens the valve for the same duration, T, as used during testing for Delivered-Dose Uniformity.
to:
Adjust the timer controlling the operation of the two-way solenoid valve so that it opens this valve for a duration such that the total volume sampled is at least 4 L.

Footnote d of Impurity Table: Change
(5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-((2′-(2-trityl-1H-tetrazol-5-yl)biphenyl-4-yl)methyl)-1H-imidazole-5-carboxylate.
to:
(5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-((2′-(2-trityl-2H-tetrazol-5-yl)biphenyl-4-yl)methyl)-1H-imidazole-5-carboxylate.

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 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 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 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 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 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 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>.