Errata - English

Line 7 of Analysis: Change
Result = (R_U/R_S) × (C_S/C_U) × P × F × 100
to:
Result = (R_U/R_S) × (C_S/C_U) × P × 100
AND
Line 17 of Analysis: Change
P = potency of cefadroxil in USP Cefadroxil RS (µg/mg)
to:
P = potency of cefazolin in USP Cefazolin RS (mg/mg)
AND
Line 19 of Analysis: Delete
F = conversion factor, 0.001 mg/µg

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 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 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 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.

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)

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.

Footnote 2: Change
http://whqlibdoc.who.int/trs/WHO_TRS_917_annex2.pdf (Accessed June 30, 2011)
to:
http://who.int/medicines/areas/quality_safety/quality_assurance/GoodtradeDistributionPracticesTRS917Annex2.pdf?ua=1 (Accessed March 2, 2015)

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 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)

Footnote 11: Delete
http://www.fda.gov/ForIndustry/ImportProgram/AdmissibilityDeterminationsforShipmentsofForeign-originOASIS/ucm077691.htm (Accessed June 6, 2011).

Line 6 of Analysis: Change
Result = (R_U/R_S) × (C_S/C_U) × 100
to:
Result = (R_U/R_S) × (C_S/C_U) × (M_r1/M_r2) × 100
AND
After C_U in definition list: Add
M_r1 = molecular weight of codeine phosphate hemihydrate, 406.37
M_r2 = molecular weight of anhydrous codeine phosphate, 397.37

Line 1 of Standard solution: Change
0.56 mg/mL of USP Ciprofloxacin Hydrochloride RS in Medium
to:
0.62 mg/mL of USP Ciprofloxacin Hydrochloride RS in Medium
AND
Line 8 of Analysis: Change
C_S = concentration of ciprofloxacin in the Standard solution (mg/mL)
to:
C_S = concentration of ciprofloxacin hydrochloride in the Standard solution (mg/mL)

Line 1 of System suitability solution: Change
Transfer 2.0 mL of System suitability stock solution A and System suitability stock solution B
to:
Transfer 2.0 mL of each System suitability stock solution A and System suitability stock solution B
AND
Line 2 of Standard solution A: Change
Mix 5.0 of the solution
to:
Mix 5.0 mL of the solution