Errata - English

Line 2 of USP Risperidone Related Compounds Mixture RS: Change
Contains a mixture of the following four compounds:
98.9% of Risperidone.
0.5% of Risperidone cis-N-oxide: cis-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-N-oxide.
0.3% of Bicyclorisperidone: 3-(4-Fluoro-2-hydroxyphenyl)-1-[2-(6,7,8,9-tetrahydro-2-methyl-4-oxo-4H-pyrido-[1,2-a]pyrimidin-3-yl)ethyl]-1-aza-2-azoniabicyclo[2.2.2]oct-2-ene iodide.
0.3% of Z-Oxime: (Z)-3-[2-[4-(2,4-Difluorophenyl)(hydroxyimino)methyl]-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one.
to:
Contains a mixture of the following four compounds:
Risperidone.
Risperidone cis-N-oxide: cis-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one, N-oxide.
Bicyclorisperidone: 3-(4-Fluoro-2-hydroxyphenyl)-1-[2-(6,7,8,9-tetrahydro-2-methyl-4-oxo-4H-pyrido-[1,2-a]pyrimidin-3-yl)ethyl]-2-aza-1-azoniabicyclo[2.2.2]oct-2-ene iodide.
Z-Oxime: (Z)-3-[2-[4-(2,4-Difluorophenyl)(hydroxyimino)methyl]-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one.

Change
pH 7.0 Buffer, pH 5.0 Buffer, Mobile phase, Standard preparation, Resolution solution, and Chromatographic system—Prepare as directed in the Assay under Ceftriaxone Sodium.
to:
pH 7.0 Buffer—Dissolve 13.6 g of dibasic potassium phosphate and 4.0 g of monobasic potassium phosphate in water to obtain 1000 mL of solution. Adjust this solution with phosphoric acid or 10 N potassium hydroxide to a pH of 7.0 ± 0.1.
pH 5.0 Buffer—Dissolve 25.8 g of sodium citrate in 500 mL of water, adjust with citric acid solution (1 in 5) to a pH of 5.0 ± 0.1, and dilute with water to a volume of 1000 mL.
Mobile phase—Dissolve 3.2 g of tetraheptylammonium bromide in 400 mL of acetonitrile, add 44 mL of pH 7.0 Buffer and 4 mL of pH 5.0 Buffer, and add water to make 1000 mL. Pass through a membrane filter of 0.5-μm or finer porosity, and degas. Make adjustments if necessary (see System Suitability under Chromatography <621>).
Standard preparation—Dissolve an accurately weighed quantity of USP Ceftriaxone Sodium RS in Mobile phase to obtain a solution having a known concentration of about 0.2 mg per mL. Use this solution promptly after preparation.
Resolution solution—Dissolve a suitable quantity of USP Ceftriaxone Sodium E-Isomer RS in Standard preparation, and dilute with Mobile phase to obtain a solution containing about 160 µg of USP Ceftriaxone Sodium E-Isomer RSper mL and 160 µg of USP Ceftriaxone Sodium RSper mL. Use this solution promptly after preparation.
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 270-nm detector and a 4.0-mm × 15-cm column that contains 5-μm packing L1. The flow rate is about 2 mL per minute. Chromatograph the Resolution solution, and record the peak responses as directed for Procedure. The resolution, R, between the ceftriaxone E-isomer and ceftriaxone peaks is not less than 3. Chromatograph the Standard preparation, and record the peak responses as directed under Procedure. The column efficiency determined from the analyte peak is not less than 1500 theoretical plates, the tailing factor for the analyte is not more than 2, and the relative standard deviation for replicate injections is not more than 2%.
AND
Change
Procedure—Proceed as directed for Procedure in the Assay under Ceftriaxone Sodium. Calculate the quantity, in mg, of ceftriaxone (C₁₈H₁₈N₈O₇S₃) in each mL of the Injection taken by the formula:
200(C / V)(r_U / r_S)
in which V is the volume, in mL, of Injection taken; and the other terms are as defined therein.
to:
Procedure—Separately inject equal volumes (about 20 μL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of ceftriaxone (C₁₈H₁₈N₈O₇S₃) in each mL of Injection taken by the formula:
200(C / V)(r_U / r_S)
in which C is the concentration, in mg per mL, of USP Ceftriaxone Sodium RS in the Standard preparation; V is the volume, in mL, of Injection taken; and r_U and r_S are the ceftriaxone peak responses obtained from the Assay preparation and the Standard preparation, respectively.

Change
Uniformity of Dosage Units, Content Uniformity <905>
to:
Uniformity of Dosage Units <905>: Meet the requirements
The following procedure is used where the test for Content Uniformity is required.
Procedure for Content Uniformity
AND
Delete a subsection:
Acceptance criteria: Meet the requirements

Line 2 of USP Levalbuterol Related Compound H RS: Change
4-[2-(tert-Butylamino)-1-methoxyethyl]-2-(hydroxymethyl)phenol.
C₁₄H₂₃NO₃ 253.34
to:
4-[2-(tert-Butylamino)-1-methoxyethyl]-2-(hydroxymethyl)phenol acetate.
C₁₄H₂₃NO₃ · C₂H₄O₂ 313.39

Line 5 of Magnesium stock solution: Change
Transfer 2.0 mL of this solution to a 100-mL volumetric flask to obtain a solution containing 20 μg/mL of magnesium (Mg)
to:
Transfer 1.0 mL of this solution to a 100-mL volumetric flask to obtain a solution containing 10 μg/mL of magnesium (Mg)

Row 13 of Column 1 of Table 2: Change
3-Epimer^m
to:
3R-Epimer^m
AND
Row 16 of Column 1 of Table 2: Change
5-Epimer^p
to:
5R-Epimer^p
AND
Row 17 of Column 1 of Table 2: Change
Valine urea analog^q
to:
Diacyl valine urea^q

Footnote a of Table 1: Change
(S)-N-Butyryl-N-([2′-(1H-tetrazole-5-yl)biphen-4-yl]methyl)-valine.
to:
N-Butyryl-N-{[2′-(1H-tetrazole-5-yl)biphenyl-4-yl]methyl}-L-valine.
AND
Footnote b of Table 1: Change
(S)-N-Valeryl-N-([2′-(1H-tetrazole-5-yl)biphen-4-yl]methyl)-valine benzyl ester.
to:
N-Valeryl-N-{[2′-(1H-tetrazole-5-yl)biphenyl-4-yl]methyl}-L-valine benzyl ester.

Line 5 of Analysis in Limit of Gallic Acid: Change
Separately calculate the percentages of gallic acid
to:
Calculate the percentage of gallic acid
AND
Line 5 of Analysis in Limit of Caffeine: Change
Separately calculate the percentages of caffeine
to:
Calculate the percentage of caffeine

Line 12 of Analysis: Change
C_S = concentration of 3,5-dimethylphenol or chloroxylenol related compound A in the Standard solution (mg/mL)
to:
C_S = concentration of 3,5-dimethylphenol or USP Chloroxylenol Related Compound A RS in the Standard solution (mg/mL)

Line 14 of Analysis in Content of Total Phenols: Change
C_S = concentration of the relevant analyte in the corresponding Standard solution
C_U = concentration of Echinacea purpurea in the Sample solution (mg/mL)
to:
C_S = concentration of the relevant analyte in the corresponding Standard solution (mg/mL)
C_U = concentration of Powdered Echinacea purpurea Extract in the Sample solution (mg/mL)
AND
Line 20 of Analysis in Content of Dodecatetraenoic Acid Isobutylamides: Change
C_U = concentration of Echinacea purpurea in the Sample solution (mg/mL)
to:
C_U = concentration of Powdered Echinacea purpurea Extract in the Sample solution (mg/mL)