Errata - English

Line 4 of Analysis: Change
Result = (r_U/r_S) × (C_S/L) × (D/V) × P × F × 100
to:
Result = (r_U/r_S) × (C_S/L) × V × D × P × F × 100
AND
Transpose lines 12 and 13 of the variable definition list to match the order in the equation

Change the subsection:
Mobile phase and Internal standard solution—Prepare as directed in the Assay under Aminosalicylic Acid.
to:
Mobile phase—Prepare as directed in the Assay under Aminosalicylic Acid.
Internal standard solution—Prepare a solution of sulfanilamide in Mobile phase having a concentration of about 5 µg per mL.

Line 1 of Test solution: Change
Use the Assay preparation, prepared as directed in the Assay.
to:
Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 500 mg of aminosalicylic acid, to a 100-mL low-actinic volumetric flask. Add 50 mL of Mobile phase, and shake for about 5 minutes. Dilute with Mobile phase to volume, and mix. Filter, and transfer 10.0 mL of the clear filtrate to a 100-mL low-actinic volumetric flask containing 10.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix.

Line 4 of USP Reference Standards: Change
8-Chloro-6,11-dihydro-11-(4-piperidylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine.
to:
8-Chloro-5,6-dihydro-11-(piperidin-4-ylidene)-11H-benzo[5,6]cyclohepta[1,2-b]pyridine.
AND
Line 6: Change
310.83
to:
310.82
AND
Line 8: Change
8-Chloro-6,11-dihydro-11-(N-methyl-4-piperidylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine.
to:
8-Chloro-5,6-dihydro-11-(N-methylpiperidin-4-ylidene)-11H-benzo[5,6]cyclohepta[1,2-b]pyridine.
AND
Line 10: Change
324.88
to:
324.85

Lines 6 and 7 of Procedure: Change
r_U × C_S × 900 × 100/r_S × D × LC
to:
r_U × C_S × 1000 × 100/r_S × D × LC
AND
Line 11 of Procedure: Change
900 is the volume
to:
1000 is the volume

Line 16 of Analysis: Change
D = dilution factor, Sample stock solution to Sample solution, 25
to:
D = dilution factor, Sample stock solution to Sample solution
AND
Line 29 of Analysis: Change
D = dilution factor, Sample stock solution to Sample solution, 25
to:
D = dilution factor, Sample stock solution to Sample solution

Line 2: Change
Mobile phase and Chromatographic system—Proceed as directed in the Assay under Triazolam.
to:
Mobile phase—Prepare a filtered and degassed mixture of acetonitrile, chloroform, butyl alcohol, water, and glacial acetic acid (850:80:50:20:0.5). Make adjustments if necessary (see System Suitability under Chromatography <621>).
AND
After the Assay preparation subsection: Add a new subsection
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 254-nm detector and a 4.6-mm × 30-cm column that contains packing L3. The flow rate is about 2.0 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed under Procedure: the relative retention times are 1 for triazolam and about 1.4 for the internal standard, the resolution, R, between the internal standard and triazolam is not less than 2.0, and the relative standard deviation for replicate injections is not more than 2.0%.
AND
Line 4 of Procedure: Change
Calculate the quantity, in mg, of C₁₇H₁₂Cl₂N₄ in the portion of Triazolam taken by the formula:
to:
Calculate the quantity, in mg, of C₁₇H₁₂Cl₂N₄ in the portion of Tablets taken by the formula:
AND
Line 9 of Procedure: Change
R_U and R_S are the ratios of the internal standard peak area to the triazolam peak area obtained from the Assay preparation and the Standard preparation, respectively.
to:
R_U and R_S are the ratios of the triazolam peak area to the internal standard peak area obtained from the Assay preparation and the Standard preparation, respectively.

Delete the subsection Standard solution and Diluted standard solution.
Replace with:
Standard solution—Dissolve an accurately weighed quantity of USP Vinorelbine Tartrate RS in Mobile phase to obtain a solution having a known concentration of about 1.4 mg per mL.
Diluted standard solution—Transfer 1.0 mL of the Standard solution to a 50-mL volumetric flask, and dilute with Mobile phase to volume. Pipet 1.0 mL of this solution into a 100-mL volumetric flask, and dilute with Mobile phase to volume.
AND
Line 1 of Procedure: Change
Proceed as directed for Procedure in the test for Related compounds under Vinorelbine Tartrate.
to:
Separately inject equal volumes (about 20 µL) of the Test solution and the Diluted standard solution into the chromatograph, record the chromatograms, and measure the areas for the major peaks. Record the chromatograms for three times the retention time of the vinorelbine peak. Disregard any peaks with an area less than or equal to one-half of the area of the peak obtained for vinorelbine in the Diluted standard solution. Calculate the percentage of each impurity in the portion of Injection taken by the formula:
100(r_i/r_s)
in which r_i is the peak response for each impurity obtained from the Test solution; and r_s is the sum of the responses of all the peaks.

Line 5 of Analysis: Change
Result = [r_UA/(Σr_UA + 25r_UB)] × 100
to:
Result = [r_UA/(Σr_UA + 30r_UB)] × 100
AND
Change line 12 of Analysis:
Result = [Σr_UA/(Σr_UA + 25r_UB)] × 100
to:
Result = [Σr_UA/(Σr_UA + 30r_UB)] × 100

Line 1: Change
Phosphate buffer, Mobile phase, and System suitability solution—Proceed as directed in the Assay under Vinorelbine Tartrate.
to:
Phosphate buffer—Dissolve 6.9 g of monobasic sodium phosphate in 900 mL of water. Adjust with phosphoric acid to a pH of 4.2, dilute with water to 1000 mL, and mix.
Mobile phase—Dissolve 1.22 g of sodium 1-decanesulfonate in 620 mL of methanol. Add 380 mL of Phosphate buffer, mix, filter, and degas. Make adjustments if necessary (see System Suitability under Chromatography <621>).
System suitability solution—Dissolve accurately weighed quantities of USP Vinorelbine Tartrate RS and USP Vinorelbine Related Compound A RS in water, and dilute quantitatively, and stepwise if necessary, with water to obtain a solution having known concentrations of about 1.4 mg per mL and 0.01 mg per mL, respectively. Expose a portion of this solution in a suitable xenon lamp apparatus capable of supplying a dose of 1600 KJ/m² between 310 and 800 nm at a power of 500 W/m² for about 1 h, in order to generate an additional degradation product 3,6-epoxy vinorelbine having a relative retention time of about 0.8.

Line 3 of Analysis: Change
Result = (r_U/r_S) × (C_S/L) × V × 100
to:
Result = (r_U/r_S) × (C_S/L) × V × D x 100
AND after Line 8 of Analysis: Add
D = dilution factor of the Sample solution

Line 15 of Analysis: Change
Result = 10 × (C/W) × {[(A_U2 − A_U1) × (A_B2 − A_B1)]/[(A_S2 − A_S1) − (A_B2 − A_B1)]}
to:
Result = 100 × (C_S/C_U) × {[(A_U2 − A_U1) − (A_B2 − A_B1)]/[(A_S2 − A_S1) − (A_B2 − A_B1)]}
AND
Line 17 of Analysis: Change
C = concentration of acetaldehyde in the Standard solution (mg/mL)
W = weight of Povidone taken (g)
to:
C_S = concentration of acetaldehyde in the Standard solution (mg/mL)
C_U = concentration of Sample solution (mg/mL)