Errata - English

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 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

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 2 of USP Ranitidine Related Compound C RS: Change
N-[2-[[[5-[(Dimethylamino)methyl]-2-furanyl]methyl]sulfinyl]ethyl]-N-methyl-2-nitro-1,1-ethenediamine.
to:
N-{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)sulfinyl]ethyl}-N′-methyl-2-nitro-1,1-ethenediamine.

Line 1 of Standard solution: Change
Prepare 1.0 mg/mL of USP Myristyl Alcohol RS in Internal standard solution, and heat the solution in a sealed container in a 50° water bath until myristyl alcohol is dissolved. Allow the solution to cool to room temperature, and mix well.
to:
1.0 mg/mL of USP Myristyl Alcohol RS in Internal standard solution
AND
Line 1 of Sample solution: Change
Prepare 1.0 mg/mL of Myristyl Alcohol in Internal standard solution, and heat the solution in a sealed container in a 50° water bath until myristyl alcohol is dissolved. Allow the solution to cool to room temperature, and mix well.
to:
1.0 mg/mL of Myristyl Alcohol in Internal standard solution

Line 2 of USP Ranitidine Related Compound C RS: Change
N-[2-[[[5-[(Dimethylamino)methyl]-2-furanyl]methyl]sulfinyl]ethyl]-N-methyl-2-nitro-1,1-ethenediamine.
to:
N-{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)sulfinyl]ethyl}-N′-methyl-2-nitro-1,1-ethenediamine.

Footnote a of Table 1: Change
Ethyl (12RS,13aSR,13bSR)-13a-ethyl-12-hydroxy-2,3,5,6,12,13,13a,13b-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (ethyl vincaminate).
to:
Ethyl (12S,13aS,13bS)-13a-ethyl-12-hydroxy-2,3,5,6,12,13,13a,13b-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (ethyl vincaminate).
AND
Footnoteb of Table 1: Change
Methyl (13aS,13bS)-13a-ethyl-9-methoxy-2,3,5,6,13a,13b-hexahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (apovincamine).
to:
Methyl (13aS,13bS)-13a-ethyl-2,3,5,6,13a,13b-hexahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (apovincamine).
AND
Footnote d of Table 1: Change
Ethyl (12RS,13aRS,13bRS)-13a-ethyl-2,3,5,6,12,13,13a,13b-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (dihydrovinpocetine).
to:
Ethyl (12R,13aS,13bS)-13a-ethyl-2,3,5,6,12,13,13a,13b-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (dihydrovinpocetine).

In the numerator of the equation: Change
2.8
to:
14
AND
Add
× f
AND
Line 10: Change
where %LOD is the percentage of loss on drying.
to:
where f is the correction factor obtained in the standardization of 0.2 N sodium hydroxide and %LOD is the percentage of loss on drying.