Errata - English

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 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 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 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 13 of Analysis in Test 1: Change
M_r2 = molecular weight of ciprofloxacin hydrochloride, 367.81
to:
M_r2 = molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81
AND
Line 12 of Analysis in Test 2: Change
M_r2 = molecular weight of ciprofloxacin hydrochloride, 367.81
to:
M_r2 = molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81
AND
Line 13 of Analysis in Test 3: Change
M_r2 = molecular weight of ciprofloxacin hydrochloride, 367.81
to:
M_r2 = molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81

Line 1 of Sample: Change
6 mg/mL of phenytoin sodium in water from a suitable number of Capsules prepared as follows. Nominally transfer 300 mg of the powder into 50 mL of water in a separator.
to:
300 mg of phenytoin sodium from the contents of Capsules in 50 mL of water in a separator.

Line 16 of Analysis: Change
C_U = nominal concentration of citric acid monohydrate in the Assay preparation for citric acid/citrate assay (units/mL)
to:
C_U = nominal concentration of citric acid monohydrate in the Assay preparation for citric acid/citrate assay (µg/mL)

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 5 of Analysis: Change
Result = (r_U/r_S) × C_S × (M_r1/M_r2) × 100
to:
Result = (r_U/r_S) × C_S × (M_r1/M_r2)

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:

Line 16 of Analysis: Change
M_r2 = molecular weight of ciprofloxacin hydrochloride, 367.81
to:
M_r2 = molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81
AND
Line 14 of the second Calculate statement in Analysis: Change
M_r2 = molecular weight of ciprofloxacin hydrochloride, 367.81
to:
M_r2 = molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81