Errata - English

In System suitability/Suitability requirements/Relative standard deviation: Change
NMT 10.0% for the tributyl phosphine oxide and osteltamivir phosphate peaks
to:
NMT 10.0% for the tributyl phosphine oxide and oseltamivir phosphate peaks

In Chromatographic system and Procedure: Change
C is the concentration, in mg per mL, of USP Dextromethorphan Hydrobromide RS, on the anhydrous basis, in the Standard preparation;
to:
C is the concentration, in mg per mL, of USP Dextromethorphan Hydrobromide RS in the Standard preparation;

In General Pharmacopeial Requirements/Pesticide Residues: Change
where L is the limit in the original article as listed in Table 4 (see Pesticide Residue Analysis under Articles of Botanical Origin <561>)
to:
where L is the limit in the original article as listed in Table 5 (see Pesticide Residue Analysis under Articles of Botanical Origin <561>)

In Test 1, Test 3, Test 4, Test 5, and Test 6/Analysis: Change
M_r1 = molecular weight of atorvastatin, 558.64
M_r2 = molecular weight of atorvastatin calcium, 1155.34
to:
M_r1 = molecular weight of atorvastatin, 558.65
M_r2 = molecular weight of atorvastatin calcium, 1155.36

In Dissolution 〈711〉/Test 2/Acid stage: Change
Acid stage standard solution: (L/10) mg/mL of USP Pantoprazole Sodium RS from the Standard stock solution in Acid stage medium, where L is the label claim in mg/Tablet
to:
Acid stage standard solution: (L/10000) mg/mL of USP Pantoprazole Sodium RS from the Standard stock solution in Acid stage medium, where L is the label claim in mg/Tablet
AND
In Dissolution <711>/Test 2/Buffer stage: Change
Buffer stage standard solution: (L/1000) of USP Pantoprazole Sodium RS where L is the label claim in mg/Tablet
to:
Buffer stage standard solution: (L/1000) mg/mL of USP Pantoprazole Sodium RS from the Standard stock solution in Buffer stage medium, where L is the label claim in mg/Tablet

In USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide, monohydrochloride.
C₂₂H₂₄N₂O₈ · HCl 480.13
to:
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide hydrochloride.
C₂₂H₂₄N₂O₈ · HCl 480.90

Change
System suitability solution: 5 µg/mL each of USP Promethazine Hydrochloride RS and USP Promethazine Related Compound B RS from the Standard stock solution and System suitability stock solution, respectively
Standard solution: 5 µg/mL of USP Promethazine Hydrochloride RS from the Standard stock solution
Sensitivity solution: 0.25 µg/mL of USP Promethazine Hydrochloride RS from the Standard solution
to:
System suitability solution: 5 µg/mL each of USP Promethazine Hydrochloride RS and USP Promethazine Related Compound B RS from the Standard stock solution and System suitability stock solution, respectively, in Diluent
Standard solution: 5 µg/mL of USP Promethazine Hydrochloride RS from the Standard stock solution in Diluent
Sensitivity solution: 0.25 µg/mL of USP Promethazine Hydrochloride RS from the Standard solution in Diluent

Change
Buffer, Mobile phase, System suitability solution, Standard solution, Sample solution, and Chromatographic system: Proceed as directed in the Assay.
to:
Buffer, Mobile phase, System suitability solution, Standard solution, Sample solution, and Chromatographic system: Proceed as directed in the Assay, and use 40 µL injection volume for the Sensitivity solution.

In USP Metaraminol Enantiomer RS: Change
3-[(1S,2R)-2-Amino-1-hydroxypropyl]phenol.
C₉H₁₃NO₂ 167.21
to:
3-[(1S,2R)-2-Amino-1-hydroxypropyl]phenol D-tartrate.
C₉H₁₃NO₂ ∙ C₄H₆O₆ 317.29

In Chromatographic system/Column: Change
4-mm × 30-cm; packing L1
to:
3.9-mm × 30-cm; packing L1
AND
In System suitability: Change
[Note—The relative retention times for bupivacaine hydrochloride and dibutyl phthalate are about 1.0 and 1.2, respectively.]
to:
[Note—The relative retention times for bupivacaine and dibutyl phthalate are about 1.0 and 1.2, respectively.]
AND
In System suitability/Suitability requirements: Change
Resolution: NLT 2.0 between bupivacaine hydrochloride and dibutyl phthalate
Relative standard deviation: NMT 1.0% for the ratio of bupivacaine to the internal standard from three replicate injections
to:
Resolution: NLT 2.0 between bupivacaine and dibutyl phthalate
Relative standard deviation: NMT 1.0% for the peak response ratio of bupivacaine to the internal standard from three replicate injections

In Organic Impurities/System suitability: Change
Sample: Standard solution
[Note—The relative retention times for methoxy tamsulosin, tamsulosin, ethoxyphenoxy ethyl bromide, and desethoxy tamsulosin are 0.73, 1.00, 1.80, and 2.80, respectively.]
Suitability requirements
Tailing factor: NMT 2.0
Relative standard deviation: NMT 5.0%
Signal-to-noise ratio: NLT 10
to:
Samples: Standard solution and Sensitivity solution
[Note—The relative retention times for methoxy tamsulosin, tamsulosin, ethoxyphenoxy ethyl bromide, and desethoxy tamsulosin are 0.73, 1.00, 1.80, and 2.80, respectively.]
Suitability requirements
Tailing factor: NMT 2.0, Standard solution
Relative standard deviation: NMT 5.0%, Standard solution
Signal-to-noise ratio: NLT 10, Sensitivity 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.

In footnote b: Change
9-{(E)-4-[(2R,3aS,6S,7S,8aRS)-2-{(1RS,2S,3S)-1,3-Dihydroxy-2-methylbutyl}-7-hydroxyhexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyloxy}nonanoic acid.
to:
9-{(E)-4-[(2R,3aS,6S,7S)-2-{(1RS,2S,3S)-1,3-Dihydroxy-2-methylbutyl}-7-hydroxyhexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyloxy}nonanoic acid.

In Analysis: Change
Calculate the percentage of ceftiofur (C₁₉H₁₇N₅O₇S₃) in the portion of Ceftiofur Hydrochloride taken:
Result = (r_U/r_S) × (C_S/C_U) × P × 100
to:
Calculate the quantity, in µg/mg, of ceftiofur (C₁₉H₁₇N₅O₇S₃) in the portion of Ceftiofur Hydrochloride taken:
Result = (r_U/r_S) × (C_S/C_U) × P

In Limit of Unspecified Impurities: Change
Mobile phase and Chromatographic system: Proceed as directed in the Assay.
to:
Mobile phase, Standard stock solution, and Chromatographic system: Proceed as directed in the Assay.

Change
Proceed as directed in the Identification test under Erythromycin Ethylsuccinate Oral Suspension, beginning with “Prepare a Standard solution.”
to:
Prepare a Standard solution of USP Erythromycin Ethylsuccinate RS in methanol containing about 3 mg per mL. Apply separately 10 µL each of the test solution and the Standard solution to a suitable thin-layer chromatographic plate (see Chromatography 〈621〉) coated with a 0.25-mm layer of chromatographic silica gel mixture, and allow to dry. Place the plate in an unlined chromatographic chamber, and develop the chromatograms in a solvent system consisting of a mixture of methanol and chloroform (85:15) until the solvent front has moved about 9 cm. Remove the plate from the chamber, mark the solvent front, and allow the solvent to evaporate. Spray the plate with a mixture of dehydrated alcohol, p-methoxybenzaldehyde, and sulfuric acid (90:5:5). Heat the plate at 100° for 10 minutes, and examine the chromatograms, in which the erythromycin and succinic acid moieties appear as black-to-purple spots: the R_F values of the principal spots obtained from the test solution correspond to those obtained from the Standard solution.

Change
Characteristic emission lines for calcium at 184.0, 315.9, and 317.9 nm from the Sample solution correspond to those from the Standard solution, as obtained in the Assay.
to:
Characteristic emission lines for calcium at 184.0, 315.9, and 317.9 nm from the Sample solution correspond to those from the Standard solution, as obtained in the Content of Calcium.

In A.: Change
Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197A, 197K, and 197S
to:
Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197A, 197K, or 197S
Procedure for 197S