Errata - English

Line 5: Change
Potassium stock solution and Standard preparations—
to:
Standard stock solution and Standard solutions—
AND
Line 7 of Procedure: Change
for Procedure in the Assay under Potassium Chloride Oral Solution.
to:
for Instrumental conditions and Analysis in the Assay under Potassium Chloride Oral Solution.

Line 2: Change
Potassium stock solution and Standard preparations—
to:
Standard stock solution and Standard solutions—
AND
Line 1 of Procedure: Change
for Procedure in the Assay under Potassium Chloride Oral Solution.
to:
for Instrumental conditions and Analysis in the Assay under Potassium Chloride Oral Solution, except use Assay preparation instead of Sample solution.

Line 1: Change
It meets the requirements of the test for Chromatographic purity under Albuterol, except to read Albuterol Sulfate in place of Albuterol and to use water instead of methanol as the solvent to prepare the Standard solution and the Test solution.
to:
It meets the requirements of the test for Organic Impurities under Albuterol, except to read Albuterol Sulfate in place of Albuterol and to use water instead of methanol as the solvent to prepare the Standard solution and the Sample solution.

Line 2: Change
Mobile phase, Standard preparation, Resolution solution, and Chromatographic system—Proceed as directed in the Assay under Minocycline Hydrochloride.
to:
Mobile phase—Prepare a mixture of 0.2 M ammonium oxalate, 0.01 M edetate disodium, dimethylformamide, and tetrahydrofuran (600:180:120:80). Adjust with ammonium hydroxide to a pH of 7.2, and pass through a filter of 0.5-µm or finer pore size. Make adjustments if necessary (see System Suitability under Chromatography <621>).
Standard preparation—Dissolve an accurately weighed quantity of USP Minocycline Hydrochloride RS in water to obtain a solution having a known concentration of about 500 µg of minocycline (C₂₃H₂₇N₃O₇) per mL. Use this solution within 3 hours.
Resolution solution—Transfer 10 mg of USP Minocycline Hydrochloride RS to a 25-mL volumetric flask, add 20 mL of 0.2 M ammonium oxalate, and swirl to dissolve. Heat on a water bath at 60° for 180 minutes, and allow to cool. Dilute with water to volume, and mix.
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 280-nm detector and a 4.6-mm × 25-cm column that contains 5-µm packing L1, and is maintained at a constant temperature of about 40°. The flow rate is about 1.5 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the capacity factor, k´, is not less than 5.0 and not more than 11.5; the tailing factor for the analyte peak is not less than 0.9 and not more than 2.0; and the relative standard deviation for replicate injections is not more than 2.0%. Chromatograph the Resolution solution, and record the peak responses as directed for Procedure: the relative retention times are about 0.7 for epiminocycline and 1.0 for minocycline; and the resolution, R, between epiminocycline and minocycline is not less than 4.6.
AND
Line 1 of Procedure: Change
Proceed as directed for Procedure in the Assay under Minocycline Hydrochloride.
to:
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.

Line 2: Change
Potassium stock solution and Standard preparations—
to:
Standard stock solution and Standard solutions—
AND
Line 1 of Procedure: Change
for Procedure in the Assay under Potassium Chloride Oral Solution.
to:
for Instrumental conditions and Analysis in the Assay under Potassium Chloride Oral Solution, except use Assay preparation instead of Sample solution.

Line 5: Change
Potassium stock solution—
to:
Standard stock solution—
AND
Line 7: Change
Prepare as directed for Standard preparations
to:
Prepare as directed for Standard solutions
AND
Line 7 of Procedure: Change
for Procedure in the Assay under Potassium Chloride Oral Solution.
to:
for Instrumental conditions and Analysis in the Assay under Potassium Chloride Oral Solution.

Line 4 of Analysis: Change
Determine the alcohol content of the sample thus prepared by the Gas–Liquid Chromatographic Method (see Method II in Alcohol Determination <611>, using methyl ethyl ketone as the internal standard in place of acetone.
to:
Determine the alcohol content of the sample thus prepared by the Gas Chromatographic Method (see Method II in Alcohol Determination <611>), using methyl ethyl ketone as the internal standard in place of acetonitrile.

Line 2: Change
Mobile phase, Standard preparation, Resolution solution, and Chromatographic system—Proceed as directed in the Assay under Minocycline Hydrochloride.
to:
Mobile phase—Prepare a mixture of 0.2 M ammonium oxalate, 0.01 M edetate disodium, dimethylformamide, and tetrahydrofuran (600:180:120:80). Adjust with ammonium hydroxide to a pH of 7.2, and pass through a filter of 0.5-µm or finer pore size. Make adjustments if necessary (see System Suitability under Chromatography <621>).
Standard preparation—Dissolve an accurately weighed quantity of USP Minocycline Hydrochloride RS in water to obtain a solution having a known concentration of about 500 µg of minocycline (C₂₃H₂₇N₃O₇) per mL. Use this solution within 3 hours.
Resolution solution—Transfer 10 mg of USP Minocycline Hydrochloride RS to a 25-mL volumetric flask, add 20 mL of 0.2 M ammonium oxalate, and swirl to dissolve. Heat on a water bath at 60° for 180 minutes, and allow to cool. Dilute with water to volume, and mix.
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 280-nm detector and a 4.6-mm × 25-cm column that contains 5-µm packing L1, and is maintained at a constant temperature of about 40°. The flow rate is about 1.5 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the capacity factor, k´, is not less than 5.0 and not more than 11.5; the tailing factor for the analyte peak is not less than 0.9 and not more than 2.0; and the relative standard deviation for replicate injections is not more than 2.0%. Chromatograph the Resolution solution, and record the peak responses as directed for Procedure: the relative retention times are about 0.7 for epiminocycline and 1.0 for minocycline; and the resolution, R, between epiminocycline and minocycline is not less than 4.6.
AND
Line 1 of Procedure: Change
Proceed as directed for Procedure in the Assay under Minocycline Hydrochloride.
to:
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.

Line 3 of System suitability: Change
[Note—The retention time for squalene is about 18 min; the relative retention times for tetradecane, hexadecane, and squalene are about 0.5, 0.6, and 1.0, respectively.]
to:
[Note—The retention time for squalane is about 18 min; the relative retention times for tetradecane, hexadecane, and squalane are about 0.5, 0.6, and 1.0, respectively.]

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.