Errata - English

Line 2 of USP Cefadroxil Related Compound I RS: Change
(6R,7R)-7-[(R)-2-Amino-2-(4-hydroxyphenyl)acetamido]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate.
to:
(6R,7R)-7-[(R)-2-Amino-2-(4-hydroxyphenyl)acetamido]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-3-ene-2-carboxylic acid.

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

Footnotes b, c, and d of Table 2: Change
^btrans-Isoterbinafine or (E)-N,6,6-trimethyl-N-(naphthalen-2-ylmethyl)hept-2-en-4-yn-1-amine.
^ccis-Terbinafine or (Z)-N,6,6-trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine.
^d4-Methylterbinafine or (E)-N,6,6-trimethyl-N-((4-methylnaphthalen-1-yl)methyl)hept-2-en-4-yn-1-amine.
to:
^btrans-Isoterbinafine or (2E)-N,6,6-Trimethyl-N-(naphthalen-2-ylmethyl)hept-2-en-4-yn-1-amine.
^ccis-Terbinafine or (2Z)-N,6,6-Trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine.
^d4-Methylterbinafine or (2E)-N,6,6-Trimethyl-N-((4-methylnaphthalen-1-yl)methyl)hept-2-en-4-yn-1-amine.

Change
pH 3.6 Buffer, pH 7.0 Buffer, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Cefazolin.
to:
pH 3.6 Buffer—Dissolve 0.900 g of anhydrous dibasic sodium phosphate and 1.298 g of citric acid monohydrate in water to make 1000 mL.
pH 7.0 Buffer—Dissolve 5.68 g of anhydrous dibasic sodium phosphate and 3.63 g of monobasic potassium phosphate in water to make 1000 mL.
Mobile phase—Prepare a suitable mixture of pH 3.6 Buffer and acetonitrile (9:1). Pass through a membrane filter having a 10-μm or finer porosity, and degas. Make adjustments if necessary (see System Suitability under Chromatography <621>).
Internal standard solution—Transfer 750 mg of salicylic acid to a 100-mL volumetric flask, dissolve in 10 mL of methanol, dilute with pH 7.0 Buffer to volume, and mix.
Standard preparation—Transfer about 25 mg of USP Cefazolin RS, accurately weighed, to a 25-mL volumetric flask, dissolve in and dilute with pH 7.0 Buffer to volume, and mix. Transfer 5.0 mL of this solution to a 100-mL volumetric flask, add 5.0 mL of Internal standard solution, dilute with pH 7.0 Buffer to volume, and mix.
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 254-nm detector and a 4.0-mm × 30-cm column that contains 10-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 relative retention times are about 0.7 for salicylic acid and 1.0 for cefazolin; the resolution, R, between the analyte and internal standard peaks is not less than 4.0; the column efficiency is not less than 1500 theoretical plates; the tailing factor is not more than 1.5; and the relative standard deviation for replicate injections is not more than 2.0%.
AND
Change
Procedure—Proceed as directed for Procedure in the Assay under Cefazolin. Calculate the quantity, in mg, of cefazolin (C₁₄H₁₄N₈O₄S₃) in each mL of the Injection taken by the formula:
(1000C / 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 10 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 cefazolin (C₁₄H₁₄N₈O₄S₃) in each mL of Injection taken by the formula:
(1000C / V)(R_U / R_S)
in which C is the concentration, in mg per mL, of USP Cefazolin RS, calculated on the anhydrous basis, in the Standard preparation; V is the volume, in mL, of Injection taken; and R_U and R_S are the peak response ratios of cefazolin to the internal standard obtained from the Assay preparation and the Standard preparation, respectively.

Row 3 of Column 1 of Impurity Table 1: Change
Flavoxate related compound A^a,*
to:
Flavoxate related compound A^a
AND
Row 4 of Column 1 of Impurity Table 1: Change
Flavoxate related compound B^b,*
to:
Flavoxate related compound B^b
AND
Row 5 of Column 1 of Impurity Table 1: Change
Flavoxate related compound C^c,*
to:
Flavoxate related compound C^c
AND
Delete footnote *

Line 1 of Procedure: Change
Proceed as directed in the Assay under Mitotane, beginning with “Concomitantly determine the absorbances of both solutions.”
to:
Concomitantly determine the absorbances of the Assay preparation and the Standard preparation in 1-cm cells at the wavelength of maximum absorbance at about 268 nm, with a suitable spectrophotometer, using methanol as the blank.
Calculate the quantity, in mg, of C₁₄H₁₀Cl₄ in the portion of Tablets taken by the formula:
0.5C(A_U/A_S)
in which C is the concentration, in mg/mL, of USP Mitotane RS in the Standard preparation, and A_U and A_S are the absorbances of the Assay preparation and the Standard preparation, respectively.

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)