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 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 1 or Assay preparation 2 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 5: Change
Potassium stock solution and Standard preparations—
to:
Standard stock solution and Standard solutions—
Line 1 of Procedure: Change
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 1 or Assay preparation 2 instead of Sample 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 11 of USP Tacrolimus System Suitability Mixture RS: Change
and tacrolimus 8-propyl analog
(3S,4R,5S,8S,9E,12S,14S,15R,16S,18R,19R,26aS)-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-{(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl}-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-8-propyl-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21-(4H,23H)-tetrone.
to:
and tacrolimus 8-propyl analog
(3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-{(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl}-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-8-pro-pyl-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21-(4H,23H)-tetrone.

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 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.

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

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: 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.

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 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 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.]

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 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

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