Errata - English

In USP Atorvastatin Related Compound B RS: Change
(3S,5R)-7-[3-(Phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid calcium salt.
to:
Calcium (3S,5R)-7-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate (1:2); also known as (3S,5R)-7-[3-(Phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid calcium salt.

In the second Calculate statement in Analysis: Change
(C₃₃H₃₄FN₂O₅)
to:
(C₃₃H₃₅FN₂O₅)
AND
In Tolerances: Change
(C₃₃H₃₄FN₂O₅)
to:
(C₃₃H₃₅FN₂O₅)

In Chromatographic system: Change
Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the standard deviation for replicate injections is not more than 2.0%.
to:
Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the relative standard deviation for replicate injections is not more than 2.0%.

In Chromatographic system: Change
Chromatograph the Standard solution, and record the peak responses as directed for Procedure: the standard deviation for replicate injections is not more than 10.0%.
to:
Chromatograph the Standard solution, and record the peak responses as directed for Procedure: the relative standard deviation for replicate injections is not more than 10.0%.

In Analysis: Change
M_W(Salt) = molecular weight of ammonium glycyrrhizate, 840.08 g/mol
M_W(Acid) = molecular weight of glycyrrhizic acid, 821.59 g/mol
to:
M_W(Salt) = molecular weight of ammonium glycyrrhizate, 839.97 g/mol
M_W(Acid) = molecular weight of glycyrrhizic acid, 822.94 g/mol

Change
Application volume, Developing solvent system, Procedure—Proceed as directed for the Identification test under Amoxicillin Tablets.
to:
Application volume—5 µL.
Developing solvent system—a mixture of methanol, chloroform, water, and pyridine (90:80:30:10).
Procedure—Proceed as directed in Thin-Layer Chromatographic Identification Test <201>. Dry the plate with the aid of a current of warm air for 10 minutes. Locate the spots on the plate by spraying lightly with a solution of ninhydrin in alcohol containing 3 mg per mL, and dry at 110° for 15 minutes.

Change
Prepare a test solution containing the equivalent of 4 mg of amoxicillin per mL by adding 0.1 N hydrochloric acid to Amoxicillin for Injectable Suspension. Allow the solution to stand for 5 minutes before use: the solution responds to the Identification test under Amoxicillin Capsules.
to:
Prepare a test solution containing the equivalent of 4 mg of amoxicillin per mL by adding 0.1 N hydrochloric acid to Amoxicillin for Injectable Suspension. Allow the solution to stand for 5 minutes before use. Prepare a Standard solution of USP Amoxicillin RS in 0.1 N hydrochloric acid containing 4 mg per mL. Use within 10 minutes after preparation. Apply separately 5 µL of each solution on a thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture (see Chromatography <621>). Place the plate in a suitable chromatographic chamber, and develop the chromatogram in a solvent system consisting of a mixture of methanol, chloroform, water, and pyridine (90:80:30:10). When the solvent front has moved about three-fourths of the length of the plate, remove the plate from the chamber, and dry with warm air for 10 minutes. Locate the spots on the plate by spraying lightly with a solution of ninhydrin in alcohol containing 3 mg per mL, and dry at 110° for 15 minutes: the R_F value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.

Change
The solution obtained responds to the Identification test under Amoxicillin Capsules.
to:
Prepare a Standard solution of USP Amoxicillin RS in 0.1 N hydrochloric acid containing 4 mg per mL. Use within 10 minutes after preparation. Apply separately 5 µL of each solution on a thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture (see Chromatography <621>). Place the plate in a suitable chromatographic chamber, and develop the chromatogram in a solvent system consisting of a mixture of methanol, chloroform, water, and pyridine (90:80:30:10). When the solvent front has moved about three-fourths of the length of the plate, remove the plate from the chamber, and dry with warm air for 10 minutes. Locate the spots on the plate by spraying lightly with a solution of ninhydrin in alcohol containing 3 mg per mL, and dry at 110° for 15 minutes: the R_F value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.

Change
Shake a portion of Oral Suspension with a mixture of acetone and 0.1 N hydrochloric acid (4:1) to obtain a solution containing about 1 mg of amoxicillin per mL. The solution responds to the Identification test under Amoxicillin Capsules.
to:
Prepare a test solution by shaking a portion of Oral Suspension with a mixture of acetone and 0.1 N hydrochloric acid (4:1) to obtain a solution containing about 1 mg of amoxicillin per mL. Prepare a Standard solution of USP Amoxicillin RS in 0.1 N hydrochloric acid containing 1 mg per mL. Use within 10 minutes after preparation. Apply separately 5 µL of each solution on a thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture (see Chromatography 〈621〉). Place the plate in a suitable chromatographic chamber, and develop the chromatogram in a solvent system consisting of a mixture of methanol, chloroform, water, and pyridine (90:80:30:10). When the solvent front has moved about three-fourths of the length of the plate, remove the plate from the chamber, and dry with warm air for 10 minutes. Locate the spots on the plate by spraying lightly with a solution of ninhydrin in alcohol containing 3 mg per mL, and dry at 110° for 15 minutes: the R_F value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.

Line 4 of Analysis: Change
Result = (r_U/r_S) × (C_S/L) × (D/V) × P × F × 100
to:
Result = (r_U/r_S) × (C_S/L) × V × D × P × F × 100
AND
Transpose lines 12 and 13 of the variable definition list to match the order in the equation

Line 6 of Analysis: Change
Result = (r_U/r_S) × (C_S/C_U) × P × (1/F) ×100
to:
Result = (r_U/r_S) × (C_S/C_U) × P × F × 100

In USP Amoxicillin Related Compound A RS: Change
(2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid.
C₁₆H₁₄N₂O₂ 266.29
to:
(2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid.
C₈H₁₂N₂O₃S 216.26

Change
Result = (r_U/r_S) x (C_S/C_U) x (M_r1/M_r2) x (V/L) x 100
to:
Result = (r_U/r_S) x C_S x (M_r1/M_r2) x (V/L) x 100
AND
Delete
C_U = nominal concentration of anagrelide in the Sample solution (mg/mL)

In Analysis: Change
M = actual molarity of the Back-titrant (mM/mL)
to:
M = actual molarity of the Back-titrant (mmol/mL)
AND
Change
F = equivalency factor, 136.06 mg/mM
to:
F = equivalency factor, 136.06 mg/mmol

In Acceptance criteria/Chromatographic similarity: Change
[Note—The chromatogram of the Standard is similar to the reference chromatogram provided with the lot of being used.]
to:
[Note—The chromatogram of the Standard is similar to the reference chromatogram provided with the lot of USP Anise Oil RS being used.]

In Test 1/Apparatus 2: Change
[Note—A suitable sinker is available from VanKel, www.chem.agilent.com, catalog number 12-3050. Proper placement of the Capsules is in the sinkers with the cap facing the fixed prong end.]
to:
[Note—A suitable sinker is available from www.agilent.com, catalog number 12-3050. Proper placement of the Capsules is in the sinkers with the cap facing the fixed prong end.]

Line 2 of USP Argatroban Related Compound B RS: Change
Ethyl (2R,4R)-1-[N⁸-nitro-L-arginyl]-4-methylpiperidine-2-carboxylate hydrochloride.
C₁₅H₂₈N₆O₅ ∙ HCl 408.88
to:
Ethyl (4R)-1-[N⁸-nitro-L-arginyl]-4-methylpiperidine-2-carboxylate dihydrochloride.
C₁₅H₂₈N₆O₅ ∙ 2HCl 445.34

Delete the subsection
Blank: 140 mL of water and 1 mL of dichlorofluorescein TS
AND
The equation in the Analysis: Change
Result = [(V − B) × N × F × 100]/W
to:
Result = (V × N × F × 100)/W
AND
Line 10 of Analysis: Delete
B = Blank titrant volume (mL)

In Dissolution <711>/Test 1/Procedure/Chromatographic procedure/Analysis: Change
Result = (R_U/R_S) × C_S × V × (1/L) × 100
to:
Result = (R_U/R_S) × C_S × V × D × (1/L) × 100
AND
Add
D = dilution factor of the Sample solution, 2

In the first equation in Analysis: Change
C_S = concentration of USP Withanoside IV RS in Standard solution A (mg/mL)
to:
C_S = concentration of USP Withanolide A RS in Standard solution A (mg/mL)

Change
USP Atorvastatin Related Compound H RS (lactone impurity)
to:
USP Atorvastatin Related Compound H RS
Also known as Lactone impurity;
AND
Change
USP Atorvastatin Related Compound I RS (acetonide impurity)
to:
USP Atorvastatin Related Compound I RS
Also known as Acetonide impurity;

In USP Atorvastatin Related Compound C RS: Change
Difluoro impurity, or (3R,5R)-7-[3-(phenylcarbamoyl)-4,5-bis(4-fluorophenyl)-2-isopropyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
to:
Calcium (3R,5R)-7-[2,3-Bis(4-fluorophenyl)-5-isopropyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate (1:2); Also known as Difluoro impurity, or (3R,5R)-7-[3-(phenylcarbamoyl)-4,5-bis(4-fluorophenyl)-2-isopropyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
AND
In USP Atorvastatin Related Compound D RS: Change
Epoxide impurity, or 3-(4-fluorobenzoyl)-2-isobutyryl-3-phenyl-oxirane-2-carboxylic acid phenylamide.
to:
3-(4-Fluorobenzoyl)-2-isobutyryl-N,3-diphenyloxirane-2-carboxamide; Also known as Epoxide impurity, or 3-(4-fluorobenzoyl)-2-isobutyryl-3-phenyl-oxirane-2-carboxylic acid phenylamide.
AND
In USP Atorvastatin Related Compound E RS: Change
3S,5S Enantiomer, or (3S,5S)-7-[3-(phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
C₆₆H₆₈CaF₂N₄O₁₀ 1155.34
to:
Calcium (3S,5S)-7-[2-(4-Fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate (1:2); Also known as 3S,5S Enantiomer, or (3S,5S)-7-[3-(phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
C₆₆H₆₈CaF₂N₄O₁₀ 1155.38
AND
In USP Atorvastatin Related Compound H RS: Change
540.62
to:
540.64
AND
In Atorvastatin Related Compound I RS: Change
654.81
to:
654.82

In USP Atorvastatin Related Compound A RS: Change
Desfluoro impurity, or (3R,5R)-7-[3-(phenylcarbamoyl)-2-isopropyl-4,5-diphenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
to:
Calcium (3R,5R)-7-[2-isopropyl-4,5-diphenyl-3-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate (1:2);
Also known as Desfluoro impurity, or (3R,5R)-7-[3-(phenylcarbamoyl)-2-isopropyl-4,5-diphenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.

In USP Atorvastatin Related Compound C RS: Change
C₆₆H₆₆F₄N₄O₁₀
to:
C₆₆H₆₆CaF₄N₄O₁₀
AND
In USP Atorvastatin Related Compound E RS: Change
1155.38
to:
1155.36

In USP Atorvastatin Related Compound B RS: Change
3S,5R Isomer, or (3S,5R)-7-[3-(phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
to:
Calcium (3S,5R)-7-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate (1:2); also known as 3S,5R Isomer, or (3S,5R)-7-[3-(phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.