Errata - English

Line 11 of the variable definition list: Change
C_S = concentration of didanosine in the Standard solution (mg/mL)
to:
C_S = concentration of USP Didanosine Related Compound A RS in the Standard solution for the Acid stage or concentration of USP Didanosine RS in the Standard solution for the Buffer stage (mg/mL)

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.

Line 7 of Procedure: Change
(377.86/341.41)10C(r_U/r_S)
in which 377.86 and 341.41 are the molecular weights of naltrexone hydrochloride and naltrexone
to:
(377.86/341.40)10C(r_U/r_S)
in which 377.86 and 341.40 are the molecular weights of naltrexone hydrochloride and naltrexone

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.

Line 7 of Analysis: Change
R_U = peak response ratio of the doxapram to the internal standard from the Sample solution
R_S = peak response ratio of the doxapram to the internal standard from the Sample solution
to:
R_U = peak response ratio of doxapram to the internal standard from the Sample solution
R_S = peak response ratio of doxapram to the internal standard from the Standard solution

Row 3 of Column 1 of Table 2: Change
Camptothecin^b
to:
Camptothecin^b,d
AND
Row 5 of Column 1: Change
7-Ethylcamptothecin^c
to:
7-Ethylcamptothecin^c,d
AND
Add a footnote:
^dThese process impuritiesare included in the table for identification only and are not included in the Total impurities.

Line 2 of USP Terbinafine Related Compound A RS: Change
N-Methyl-C-(naphthalen-1-yl)methanamine.
to:
N-Methyl-C-(naphthalen-1-yl)methanamine hydrochloride.
AND
Line 2 of USP Terbinafine Related Compound B RS: Change
(2Z)-N,6,6-Trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine.
to:
(2Z)-N,6,6-Trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine hydrochloride.
AND
Line 2 of USP Terbinafine Related Compound C: Change
(2E)-N,6,6-Trimethyl-N-(naphthalen-2-ylmethyl)hept-2-en-4-yn-1-amine.
to:
(2E)-N,6,6-Trimethyl-N-(naphthalen-2-ylmethyl)hept-2-en-4-yn-1-amine hydrochloride.
AND
Line 2 of Terbinafine Related Compound D RS: Change
(2E)-N,6,6-Trimethyl-N-[(4-methylnaphthalen-1-yl)methyl]hept-2-en-4-yn-1-amine.
to:
(2E)-N,6,6-Trimethyl-N-[(4-methylnaphthalen-1-yl)methyl]hept-2-en-4-yn-1-amine hydrochloride.

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 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
Sample: Standard solution
to:
Samples: System suitability solution and Standard solution
AND
Change
Resolution: NLT 4.0 between tizanidine and tizanidine related compound C; NLT 4.0 between tizanidine and tizanidine related compound B
Tailing factor: NMT 2.0
Relative standard deviation: NMT 2.0%
to:
Resolution: NLT 4.0 between tizanidine and tizanidine related compound C; NLT 4.0 between tizanidine and tizanidine related compound B, System suitability solution
Tailing factor: NMT 2.0, Standard solution
Relative standard deviation: NMT 2.0%, Standard solution

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 *

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.