Errata - English

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)

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.

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)

Line 3 of Analysis: Change
Separately calculate the percentage of the labeled amount of sodium estrone sulfate and sodium equilin sulfate in the portion of Conjugated Estrogens taken:
to:
Separately calculate the percentage of the labeled amount of sodium estrone sulfate and sodium equilin sulfate in the portion of Tablets taken:

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.

Lines 3 and 6: Change
USP Olanzapine Related Compound A RS
5-Methyl-2-((2-nitrophenyl)amino)-3-thiophenecarbonitrile.
USP Olanzapine Related Compound B RS
2-Methyl-10H-thieno-[2,3-b][1,5]benzodiazepin-4[5H]-one.
to:
USP Olanzapine Related Compound A RS
5-Methyl-2-((2-nitrophenyl)amino)-3-thiophenecarbonitrile.
C₁₂H₉N₃O₂S 259.28
USP Olanzapine Related Compound B RS
2-Methyl-10H-thieno-[2,3-b][1,5]benzodiazepin-4[5H]-one.
C₁₂H₁₀N₂OS 230.29

Line 1 of Test preparation: Change
Use the Assay preparation, prepared as directed in the Assay.
to:
Transfer about 69 mg of Aminosalicylate Sodium, accurately weighed, to a 100-mL low-actinic volumetric flask, add 50 mL of Mobile phase, and swirl to dissolve. Add 10.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix.

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