Errata - English

Change the subsection title
Standard solution
to:
Control solution
AND
Line 4 of Analysis: Change
Standard solution
to:
Control solution
AND
Line 2 of Acceptance criteria: Change
Standard solution
to:
Control solution

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 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 1 of Sample solution: Change
Transfer 10.0 g of Inositol, weighed and calculated on the dried basis, to a 50-mL volumetric flask, and dissolve in and dilute with water (previously boiled and cooled to room temperature) to volume.
to:
0.2 g/mL of Inositol in water (previously boiled and cooled to room temperature).

Line 15 of Analysis: Change
C_S = concentration of USP Azithromycin RS in the Standard solution (µg/mL)
to:
C_S = concentration of USP Azithromycin RS in the Standard solution (mg/mL)
AND
Add after C_U:
P = potency of USP Azithromycin RS (µg/mg of azithromycin)

Footnote b: Change
cis isomer of the hydroxy compound.
to:
trans isomer of the hydroxy compound.
AND
Footnote c: Change
trans isomer of the hydroxy compound.
to:
cis isomer of the hydroxy compound.
AND
Footnote d: Change
cis isomer of the monoacrylate.
to:
trans isomer of the monoacrylate.
AND
Footnote e: Change
trans isomer of the monoacrylate.
to:
cis isomer of the monoacrylate.

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 1 of B. Thin-Layer Chromatographic Identification Test <201>: Change
The R_F value of the principal spot from Sample solution A corresponds to that from Standard solution A, as described in the test for Organic Impurities.
to:
The R_F value of the principal spot from Sample solution B corresponds to that from Standard solution A, as described in the test for Organic Impurities.

Line 3 of Flow Rate (HPLC): Change

in which F₁ is the flow rate indicated in the monograph, in mL/min; F₂ is the adjusted flow rate, in mL/min; l₁ is the length of the column indicated in the monograph; l₂ is the length of the column used; d₁ is the column inner diameter indicated in the monograph; and d₂ is the internal diameter of the column used. Additionally, the flow rate can be adjusted by ±50%.
to:

in which F₁ is the flow rate indicated in the monograph, in mL/min; F₂ is the adjusted flow rate, in mL/min; d₁ is the column inner diameter indicated in the monograph; and d₂ is the internal diameter of the column used. Additionally, the flow rate can be adjusted by ±50%.

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 of Diluent: Change
Dimethyl sulfoxide and 1 N sodium hydroxide solution (4:1)
to:
Dimethyl sulfoxide
AND
Line 1 of Standard solution: Change
3.2 μg/mL of USP Triethylamine RS in Diluent
to:
4.0 μg/mL of USP Triethylamine RS in Diluent. Transfer 4.0 mL of this solution to a 20-mL headspace vial, and add 1.0 mL of 1 N NaOH solution.
AND
Line 1 of Sample solution: Change
40 mg/mL of Adapalene in Diluent
to:
50 mg/mL of Adapalene in Diluent. Transfer 4.0 mL of this solution to a 20-mL headspace vial, and add 1.0 mL of 1 N NaOH solution.

Line 34 of Content of 1-Monoglycerides/Analysis: Change
F = equivalency factor of glyceryl monobehenate, 207.3 mg/mEq
to:
F = equivalency factor of glyceryl monobehenate, 0.2073 g/mEq
AND
Line 19 of Limit of Free Glycerin/Analysis: Change
F = equivalency factor of glycerin, 23.0 mg/mEq
to:
F = equivalency factor of glycerin, 0.023 g/mEq

Line 7 of Analysis: Change
Result = [(V_U − V_B) × F]/W
V_U = volume of 1 N sodium hydroxide consumed by the Sample (mL)
V_B = volume of 1 N sodium hydroxide consumed by the Blank (mL)
to:
Result = [(V_B − V_U) × F]/W
V_B = volume of 1 N sodium hydroxide consumed by the Blank (mL)
V_U = volume of 1 N sodium hydroxide consumed by the Sample (mL)

Column 3 of Table 1: Change in Row 1
Percentage, NMT (%)
to:
Percentage (%)
Change in Row 2
12.0
to:
NMT 12.0
Change in Row 3
6.0
to:
NMT 6.0
Change in Row 4
60.0
to:
NLT 60.0
Change in Row 5
35.0
to:
NMT 35.0
Change in Row 6
2.0
to:
NMT 2.0
Change in Row 7
2.0
to:
NMT 2.0
Change in Row 8
2.0
to:
NMT 2.0

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

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.