Errata - English

Line 2 of USP Perindopril Related Compound A RS: Change
(2S,3aS,7aS)-Octahydro-1H-indole-2-carboxylic acid hydrochloride.
C₁₇H₂₈N₂O₅ · HCl 205.68
to:
(2S,3aS,7aS)-Octahydro-1H-indole-2-carboxylic acid.
C₉H₁₅NO₂ 169.22

Line 10 of Analysis: Change
Result = (C/C_U) × [M_r/(3 × A_r)] × 100
to:
Result = C × 100/C_U
AND
Line 13 of Analysis: Change
C_U = nominal concentration, based on the Assay value, of potassium citrate monohydrate in the Sample solution (µg/mL)
M_r = molecular weight of potassium citrate monohydrate, 324.41
A_r = atomic weight of potassium, 39.10
to:
C_U = concentration of potassium citrate anhydrous (C₆H₅K₃O₇) in the Sample solution calculated from the Assay value of potassium citrate monohydrate (C₆H₅K₃O₇ · H₂O) (µg/mL)

Line 2 of USP Travoprost Related Compound A RS: Change
(5Z,13E)-(9S,11R,15R)-9,11,15-Trihydroxy-16-(m-trifluoromethylphenoxy)-17,18,19,20-tetranor-5,13-prostadienoic acid.
to:
(5Z,13E)-(9S,11R,15R)-9,11,15-Trihydroxy-16-(m-trifluoromethylphenoxy)-17,18,19,20-tetranor-5,13-prostadienoic acid
or
(Z)-7-((1R,2R,3R,5S)-3,5-Dihydroxy-2-{(R,E)-3-hydroxy-4-[3-(trifluoromethyl)phenoxy]but-1-enyl}cyclopentyl)hept-5-enoic acid.

Line 2 of first reference: Delete
http://www.acoem.org/Reproductive_Developmental_Hazard_Management.aspx.
AND
Line 2 of second reference: Delete
http://www.asco.org/advocacy/worker-safety-when-handling-hazardous-drugs-focus-statement-oncology-societies.

Line 7 of Analysis: Change
Result = (r_U/r_S) × (C/W) × (V/D) × U × (100/L)
to:
Result = (r_U/r_S) × (C/W) × D × U × (100/L)
AND
Line 16 of the Analysis: Delete
V = volume of the Sample solution (mL)

USP Oxymetazoline Related Compound A RS: Change
N-(2-Aminoethyl)-2-[4-(tert-butyl)-3-hydroxy-2,6-dimethylphenyl]acetamide.
C₁₆H₂₆N₂O₂ 278.39
to:
N-(2-Aminoethyl)-2-[4-(tert-butyl)-3-hydroxy-2,6-dimethylphenyl]acetamide hydrochloride.
C₁₆H₂₆N₂O₂ · HCl 314.85

Line 2 of USP Desloratadine Related Compound B RS: Change
8-Chloro-11-(1,2,3,6-tetrahydropyridin-4-yl)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine.
C₁₉H₁₉ClN₂ 310.82
to:
8-Chloro-11-(1,2,3,6-tetrahydropyridin-4-yl)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine hydrochloride.
C₁₉H₂₀Cl₂N₂ 347.28

Footnote k: Change
4-(4′-Chlorobiphenyl-4-yl)-1-[4-(4-fluorophenyl)-4-oxobutyl]piperidin-4-yl decanoate.
to:
4-(3′-Chlorobiphenyl-4-yl)-1-[4-(4-fluorophenyl)-4-oxobutyl]piperidin-4-yl decanoate.
AND
Footnote l: Change
4-(3′-Chlorobiphenyl-4-yl)-1-[4-(4-fluorophenyl)-4-oxobutyl]piperidin-4-yl decanoate.
to:
4-(4′-Chlorobiphenyl-4-yl)-1-[4-(4-fluorophenyl)-4-oxobutyl]piperidin-4-yl decanoate.

Line 1 of Mobile phase and Chromatographic system: Change
Prepare as directed in the Assay under TrihexyphenidylHydrochloride.
to:
Mobile phase—Prepare a mixture of acetonitrile, water, and triethylamine (920:80:0.2), adjust with phosphoric acid to a pH of 4.0, mix, filter, and degas. Make adjustments if necessary (see System Suitability under Chromatography <621>).
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 210-nm detector and a 4.6-mm × 8-cm column that contains 3-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 column efficiency determined from the analyte peak is not less than 1300 theoretical plates, the tailing factor for the analyte peak is not more than 3.0, and the relative standard deviation for replicate injections is not more than 1.0%.
AND
Line 1 of Procedure: Change
Proceed as directed for Procedure in the Assay under Trihexyphenidyl Hydrochloride.
to:
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.
AND
Line 7 of Procedure: Change
and the other terms are as defined therein.
to:
C is the concentration, in mg per mL, of USP Trihexyphenidyl Hydrochloride RS in the Standard preparation, r_U and r_S are the trihexyphenidyl peak responses obtained from the Assay preparation and the Standard preparation, respectively.

Line 1 of System suitability/Relative standard deviation: Change
NMT 2.0% for any peak
to:
NMT 2.0% for sulindac, sulindac related compound B, and sulindac related compound C
AND
Line 3 of Analysis: Change
Calculate the percentage of the labeled amount of sulindac related compound A, sulindac related compound B, or sulindac related compound C in the portion of Tablets taken:
to:
Calculate the percentage of sulindac related compound B or sulindac related compound C in the portion of Tablets taken:
AND
Line 8 of Analysis: Change
r_U = peak response of sulindac related compound A, sulindac related compound B, or sulindac related compound C from the Sample solution
to:
r_U = peak response of sulindac related compound B or sulindac related compound C from the Sample solution
AND
Line 12 of Analysis: Change
r_S = peak response of sulindac related compound A, sulindac related compound B, or sulindac related compound C from the Standard solution
to:
r_S = peak response of sulindac related compound B or sulindac related compound C from the Standard solution

Line 2 of USP Granisetron Related Compound B RS: Change
(N-[(1R,3r,5)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide).
to:
(N-[(1R,3r,5S)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide).
AND
Line 2 of USP Granisetron Related Compound E RS: Change
((1R,3rS,5S)-9-Methyl-9-azabicyclo[3.3.1]nonan-3-amine, acetate salt).
to:
((1R,3r,5S)-9-Methyl-9-azabicyclo[3.3.1]nonan-3-amine, acetate salt).

Line 4 of USP Ketorolac Related Compound A RS: Change
358.15
to:
358.39
AND
Line 3 of USP Ketorolac Related Compound B RS: Change
227.09
to:
227.26
AND
Line 3 of USP Ketorolac Related Compound C RS: Change
225.09
to:
225.24
AND
Line 3 of USP Ketorolac Related Compound D: Change
211.1
to:
211.3

Line 6 of Analysis: Change
Result = (r_U/r_S) × (C_U/C_S) × 100
to:
Result = (r_U/r_S) × (C_S/C_U) × 100

Line 1 of Mobile phase and Chromatographic system: Change
Prepare as directed in the Assay under Trihexyphenidyl Hydrochloride.
to:
Mobile phase—Prepare a mixture of acetonitrile, water, and triethylamine (920:80:0.2), adjust with phosphoric acid to a pH of 4.0, mix, filter, and degas. Make adjustments if necessary (see System Suitability under Chromatography <621>).
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 210-nm detector and a 4.6-mm × 8-cm column that contains 3-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 column efficiency determined from the analyte peak is not less than 1300 theoretical plates, the tailing factor for the analyte peak is not more than 3.0, and the relative standard deviation for replicate injections is not more than 1.0%.
AND
Line 1 of Procedure: Change
Proceed as directed for Procedure in the Assay under Trihexyphenidyl Hydrochloride.
to:
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.
AND
Line 6 of Procedure: Change
and the other terms are as defined therein.
to:
C is the concentration, in mg per mL, of USP Trihexyphenidyl Hydrochloride RS in the Standard preparation, r_U and r_S are the trihexyphenidyl peak responses obtained from the Assay preparation and the Standard preparation, respectively.

Line 2 of USP Bisoctrizole Resolution Mixture RS: Change
A mixture of approximately 1.5% of bisoctrizole isomer [phenol, 2,2-methylenebis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)]] in a matrix of bisoctrizole.
to:
A mixture of approximately 1.5% of bisoctrizole isomer [phenol, 2,2′-methylenebis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)]] in a matrix of bisoctrizole.

Line 2 of USP Lovastatin Related Compound A RS: Change
[Dihydro-lovastatin][butanoic acid, 2-methyl-, 1,2,3,4,4a,7,8,8a-octahydro-3,7-dimethyl-8-[2(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α(R*),3α,7β,8β(2S*,4S*),-8αβ]]]-.
to:
(1S,3S,4aR,7S,8S,8aS)-8-{2-[(2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran-2-yl]ethyl}-3,7-dimethyl-1,2,3,4,4a,7,8,8a-octahydronaphthalen-1-yl (S)-2-methylbutanoate.

Line 5: Change
Result = (r_U/r_S) × (C_S/C_U) × (M_r1/M_r2) × 100
to:
Result = (r_U/r_S) × (C_S/C_U)× 100
AND
Delete the variable definitions for M_r1 and M_r2.

Line 6 of Analysis: Change
Result = (r_U/r_S) × (C_U/C_S) × 100
to:
Result = (r_U/r_S) × (C_S/C_U) × 100