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.

Row 3 of Column 1 of Table 2: Change
Camptothecin^b
to:
Camptothecin^b,d
AND
Row 5 of Column 1: Change
7-Ethylcamptothecin^c
to:
7-Ethylcamptothecin^c,d
AND
Add a footnote:
^dThese process impuritiesare included in the table for identification only and are not included in the Total impurities.

Line 11 of the variable definition list: Change
C_S = concentration of didanosine in the Standard solution (mg/mL)
to:
C_S = concentration of USP Didanosine Related Compound A RS in the Standard solution for the Acid stage or concentration of USP Didanosine RS in the Standard solution for the Buffer stage (mg/mL)

Footnotes b, c, and d of Table 2: Change
^btrans-Isoterbinafine or (E)-N,6,6-trimethyl-N-(naphthalen-2-ylmethyl)hept-2-en-4-yn-1-amine.
^ccis-Terbinafine or (Z)-N,6,6-trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine.
^d4-Methylterbinafine or (E)-N,6,6-trimethyl-N-((4-methylnaphthalen-1-yl)methyl)hept-2-en-4-yn-1-amine.
to:
^btrans-Isoterbinafine or (2E)-N,6,6-Trimethyl-N-(naphthalen-2-ylmethyl)hept-2-en-4-yn-1-amine.
^ccis-Terbinafine or (2Z)-N,6,6-Trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine.
^d4-Methylterbinafine or (2E)-N,6,6-Trimethyl-N-((4-methylnaphthalen-1-yl)methyl)hept-2-en-4-yn-1-amine.

Change
pH 3.6 Buffer, pH 7.0 Buffer, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Cefazolin.
to:
pH 3.6 Buffer—Dissolve 0.900 g of anhydrous dibasic sodium phosphate and 1.298 g of citric acid monohydrate in water to make 1000 mL.
pH 7.0 Buffer—Dissolve 5.68 g of anhydrous dibasic sodium phosphate and 3.63 g of monobasic potassium phosphate in water to make 1000 mL.
Mobile phase—Prepare a suitable mixture of pH 3.6 Buffer and acetonitrile (9:1). Pass through a membrane filter having a 10-μm or finer porosity, and degas. Make adjustments if necessary (see System Suitability under Chromatography <621>).
Internal standard solution—Transfer 750 mg of salicylic acid to a 100-mL volumetric flask, dissolve in 10 mL of methanol, dilute with pH 7.0 Buffer to volume, and mix.
Standard preparation—Transfer about 25 mg of USP Cefazolin RS, accurately weighed, to a 25-mL volumetric flask, dissolve in and dilute with pH 7.0 Buffer to volume, and mix. Transfer 5.0 mL of this solution to a 100-mL volumetric flask, add 5.0 mL of Internal standard solution, dilute with pH 7.0 Buffer to volume, and mix.
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 254-nm detector and a 4.0-mm × 30-cm column that contains 10-μm packing L1. The flow rate is about 2 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure. The relative retention times are about 0.7 for salicylic acid and 1.0 for cefazolin; the resolution, R, between the analyte and internal standard peaks is not less than 4.0; the column efficiency is not less than 1500 theoretical plates; the tailing factor is not more than 1.5; and the relative standard deviation for replicate injections is not more than 2.0%.
AND
Change
Procedure—Proceed as directed for Procedure in the Assay under Cefazolin. Calculate the quantity, in mg, of cefazolin (C₁₄H₁₄N₈O₄S₃) in each mL of the Injection taken by the formula:
(1000C / V)(R_U / R_S)
in which V is the volume, in mL, of Injection taken, and the other terms are as defined therein.
to:
Procedure—Separately inject equal volumes (about 10 μL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of cefazolin (C₁₄H₁₄N₈O₄S₃) in each mL of Injection taken by the formula:
(1000C / V)(R_U / R_S)
in which C is the concentration, in mg per mL, of USP Cefazolin RS, calculated on the anhydrous basis, in the Standard preparation; V is the volume, in mL, of Injection taken; and R_U and R_S are the peak response ratios of cefazolin to the internal standard obtained from the Assay preparation and the Standard preparation, respectively.

Row 3 of Column 1 of Impurity Table 1: Change
Flavoxate related compound A^a,*
to:
Flavoxate related compound A^a
AND
Row 4 of Column 1 of Impurity Table 1: Change
Flavoxate related compound B^b,*
to:
Flavoxate related compound B^b
AND
Row 5 of Column 1 of Impurity Table 1: Change
Flavoxate related compound C^c,*
to:
Flavoxate related compound C^c
AND
Delete footnote *

Line 1 of Procedure: Change
Proceed as directed in the Assay under Mitotane, beginning with “Concomitantly determine the absorbances of both solutions.”
to:
Concomitantly determine the absorbances of the Assay preparation and the Standard preparation in 1-cm cells at the wavelength of maximum absorbance at about 268 nm, with a suitable spectrophotometer, using methanol as the blank.
Calculate the quantity, in mg, of C₁₄H₁₀Cl₄ in the portion of Tablets taken by the formula:
0.5C(A_U/A_S)
in which C is the concentration, in mg/mL, of USP Mitotane RS in the Standard preparation, and A_U and A_S are the absorbances of the Assay preparation and the Standard preparation, respectively.

Change
Sample: Standard solution
to:
Samples: System suitability solution and Standard solution
AND
Change
Resolution: NLT 4.0 between tizanidine and tizanidine related compound C; NLT 4.0 between tizanidine and tizanidine related compound B
Tailing factor: NMT 2.0
Relative standard deviation: NMT 2.0%
to:
Resolution: NLT 4.0 between tizanidine and tizanidine related compound C; NLT 4.0 between tizanidine and tizanidine related compound B, System suitability solution
Tailing factor: NMT 2.0, Standard solution
Relative standard deviation: NMT 2.0%, Standard solution

Line 2 of USP Terbinafine Related Compound A RS: Change
N-Methyl-C-(naphthalen-1-yl)methanamine.
to:
N-Methyl-C-(naphthalen-1-yl)methanamine hydrochloride.
AND
Line 2 of USP Terbinafine Related Compound B RS: Change
(2Z)-N,6,6-Trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine.
to:
(2Z)-N,6,6-Trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine hydrochloride.
AND
Line 2 of USP Terbinafine Related Compound C: Change
(2E)-N,6,6-Trimethyl-N-(naphthalen-2-ylmethyl)hept-2-en-4-yn-1-amine.
to:
(2E)-N,6,6-Trimethyl-N-(naphthalen-2-ylmethyl)hept-2-en-4-yn-1-amine hydrochloride.
AND
Line 2 of Terbinafine Related Compound D RS: Change
(2E)-N,6,6-Trimethyl-N-[(4-methylnaphthalen-1-yl)methyl]hept-2-en-4-yn-1-amine.
to:
(2E)-N,6,6-Trimethyl-N-[(4-methylnaphthalen-1-yl)methyl]hept-2-en-4-yn-1-amine hydrochloride.

Line 7 of Analysis: Change
R_U = peak response ratio of the doxapram to the internal standard from the Sample solution
R_S = peak response ratio of the doxapram to the internal standard from the Sample solution
to:
R_U = peak response ratio of doxapram to the internal standard from the Sample solution
R_S = peak response ratio of doxapram to the internal standard from the Standard solution

Line 7 of Procedure: Change
(377.86/341.41)10C(r_U/r_S)
in which 377.86 and 341.41 are the molecular weights of naltrexone hydrochloride and naltrexone
to:
(377.86/341.40)10C(r_U/r_S)
in which 377.86 and 341.40 are the molecular weights of naltrexone hydrochloride and naltrexone

Line 6 of 6.50.20. Solutions: Change
An expression such as “(1 in 10)” means that 1 part by volume of a liquid shall be diluted with a sufficient quantity of the diluent or solvent to make the volume of the finished solution 10 parts by volume. An expression such as “(20:5:2)” means that the respective numbers of parts, by volume, of the designated liquids shall be mixed, unless otherwise indicated.
to:
An expression such as “(1 in 10)” means that 1 part by volume of a liquid shall be diluted with, or 1 part by weight of a solid shall be dissolved in, a sufficient quantity of the diluent or solvent to make the volume of the finished solution 10 parts by volume. An expression such as “(20:5:2)” means that the respective numbers of parts, by volume, of the designated liquids shall be mixed, unless otherwise indicated.

Line 2 of USP Cefadroxil Related Compound I RS: Change
(6R,7R)-7-[(R)-2-Amino-2-(4-hydroxyphenyl)acetamido]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate.
to:
(6R,7R)-7-[(R)-2-Amino-2-(4-hydroxyphenyl)acetamido]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-3-ene-2-carboxylic acid.