Errata - English

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 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 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 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 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

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.

Variable definition list of second equation in Test 2/Analysis: Change
V_S = volume of the Sample solution withdrawn at each time point and replaced with Medium (mL)
to:
V_S = volume of the Sample solution withdrawn at each time point (mL)
AND
Variable definition list of second equation in Test 3/Analysis: Change
V_S = volume of the Sample solution withdrawn at each time point and replaced with Medium (mL)
to:
V_S = volume of the Sample solution withdrawn at each time point (mL)

Line 5: Change
(9RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]]ethyl]-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4H-pyrido [1,2-a]pyrimidin-4-one
to:
(9RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]]ethyl]-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one

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 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 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 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 3 of USP Trospium Chloride Related Compound C RS:Change
(1R,3r,5S)-3-Hydroxyspiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium] chloride.
to:
(1R,3r,5S)-3-Hydroxyspiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium] chloride, or (1R,3r,5S)-3-Hydroxyspiro[bicyclo[3.2.1]octane-8,1′-pyrrolidin]-1′-ium chloride.

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).

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

Line 1 of the Equation: Change
[(W_1i − W_T) − (W_14i − W_T) − (W_C1 − W_C14)] × 365 × {[100/(W_1i − W_T)] × 14}
to:
[(W_1i − W_T) − (W_14i − W_T) − (W_C1 − W_C14)] × 365 × 100/(W_1i − W_T) × 14

Delete the subsection
Blank: 140 mL of water and 1 mL of dichlorofluorescein TS
AND
The equation in the Analysis: Change
Result = [(V − B) × N × F × 100]/W
to:
Result = (V × N × F × 100)/W
AND
Line 10 of Analysis: Delete
B = Blank titrant volume (mL)

Product column: Change
10.00 (neat), 5.00, 2.50, 1.25, 0.63, 0.31, 0.16
to:
10.00 (neat), 5.00, 2.50, 1.25, 0.625, 0.3125, 0.15625
AND
Sample 1/HCP ratio column: Change
4.9, 5.7, 4.8, 5.9, 5.0, 5.1, <6
to:
4.90, 5.70, 4.80, 5.92, 4.96, 5.12, <6
AND
Sample 2/HCP ratio column: Change
2.0, 3.3, 4.0, 5.9, 5.3, 6.1, <6
to:
2.00, 3.30, 4.00, 5.92, 5.28, 6.08, <6
AND
Sample 3/HCP ratio column: Change
0.3, 0.5, 0.6, 0.9, 1.4, <6, <6
to:
0.32, 0.50, 0.60, 0.88, 1.44, <6, <6
AND
Sample 3/% max ratio value column: Change
83%
to:
61%