Errata - English

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.

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

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 690 mg of aminosalicylate sodium, 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 low-actinic, 100-mL volumetric flask containing 10.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix.

In the Note in line 11 of Titration: Change
Rinse the grains by swirling with three 15-mL portions of Purified Water, and add the washings to the main solution.
to:
Rinse the grains by swirling with three 15-mL portions of Carbon Dioxide-Free Water, and add the washings to the main solution.

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.

Footnote h of Table 3: Change
(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:
(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-propyl-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone.

Line 10 of Analysis: Change
Result = {[(V_S1 − V_B) × N × F₁]/W} × 100
to:
Result = {[(V_S2 − V_B) × N × F₁]/W} × 100
AND
Line 11 of Analysis: Change
V_S1
to:
V_S2