Errata - English

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:

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 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)

Line 6 of Analysis: Change
37 ± 0.5° at each time point.
to:
37 ± 0.5°.
AND
Line of 40 of Analysis:Delete the equation
Result₅ = ({C₅ × [V − (4 × V_s)]} + [(C₄ + C₃ + C₂ + C₁) × V_s]) × (1/L) × 100
AND
Row 5 of Column 2 of Table 11: Change
4
to:
5

Line 1: Change
It meets the requirements of the test for Related compounds under Cromolyn Sodium Inhalation Solution, “Ophthalmic Solution” being read in place of “Inhalation Solution.”
to:
Apply 10-µL portions of Ophthalmic Solution and Standard solutions of USP Cromolyn Sodium RS in a mixture of water, stabilizer-free tetrahydrofuran, and acetone (6:4:1) containing 10 mg per mL (Standard solution A) and 0.1 mg per mL (Standard solution B) to a suitable thin-layer chromatographic plate (see Chromatography <621>) coated with a 0.25-mm layer of chromatographic silica gel mixture. Allow the spots to dry, and develop the chromatogram in a solvent system consisting of a mixture of chloroform, methanol, and glacial acetic acid (9:9:2) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, mark the solvent front, and allow the solvent to evaporate. Locate the spots on the plate by viewing under short-wavelength UV light: the R_F value of the principal spot obtained from the Ophthalmic Solution corresponds to that obtained from Standard solution A. Any spot in the chromatogram obtained from the Ophthalmic Solution moving ahead of the principal spot is not more intense than the spot in the chromatogram obtained from Standard solution B (1.0%).

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.

Row 2 of Column 1 of Table 1:Change
Isoniacin
to
Isoniacin^a
AND
Row 5 of Column 1 of Table 1: Change
Picolinohydrazide
to
Picolinohydrazide^b
AND
Row 6 of Column 1 of Table 1: Change
Isonicotinonitrile
to:
Isonicotinonitrile^c
AND
Add footnotes to Table 1:
^a Isonicotinic acid.
^b 2-Isoniazid.
^c 4-Cyanopyridine.

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 2 of Peak identification solution: Change
USP Quetiapine Fumarate Related Compound B RS
to:
USP Quetiapine Related Compound B RS
AND
Line 3 of Peak identification solution: Change
USP Quetiapine Fumarate Related Compound G RS
to:
USP Quetiapine Related Compound G RS

Line 6 of Analysis: Change
Calculate the percentages of desosaminylazithromycin and N-demethylazithromycin in the portion of Azithromycin taken:
to:
Calculate the percentages of desosaminylazithromycin, N-demethylazithromycin, and azaerythromycin A in the portion of Azithromycin taken:

Line 10 of Chromatographic system: Change
Chromatograph the Standard solution, and record the peak areas as directed for Procedure: the relative standard deviation for replicate injections is not less than 2.0%.
to:
Chromatograph the Standard solution, and record the peak areas as directed for Procedure: the relative standard deviation for replicate injections is not more than 2.0%.

Line 3 of Analysis: Change
Calculate the amount of estradiol (C₁₈H₂₄O₂) dissolved:
to:
Record the chromatograms, and measure the responses for the estradiol peak. Construct a calibration curve by plotting the peak response versus concentration of the Standard solutions. Determine the amount of estradiol (C₁₈H₂₄O₂) in the Sample solutions from a linear regression analysis of the calibration curve.
Calculate the amount of estradiol (C₁₈H₂₄O₂) dissolved: