Errata - English

In Liquid Chromatography: Isocratic Elution/Injection volume: Change
L₂ = internal diameter of the column used (mm)
dc₁ = particle size indicated in the monograph (µm)
dc₂ = particle size of the column used (µm)
to:
L₂ = new column length (mm)
dc₁ = column internal diameter indicated in the monograph (mm)
dc₂ = new column internal diameter (mm)

In Light-resistant container: Change
〈661.2〉, Functionality, Spectral Transmission Requirements for Light-Resistant Components and Systems.
to:
〈661.2〉, Functionality Test Method, Spectral Transmission Requirements for Light-Resistant Components and Systems.

In footnote m in Table 2: Change
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-[N-(4-acetamidophenylsulfonyl)-N-methylamino]-3,4,6-trideoxy-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.
to:
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-[N-(4-methylphenylsulfonyl)-N-methylamino]-3,4,6-trideoxy-ß-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.

In Vitamin A, Method 3/Analysis: Change
C_S = concentration of retinyl acetate (C₂₃H₃₂O₂) from USP Vitamin A RS in the Standard solution (μg/mL)
to:
C_S = concentration of retinyl acetate (C₂₂H₃₂O₂) from USP Vitamin A RS in the Standard solution (μg/mL)

In test A: Change
The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, both relative to the internal standard, as obtained in the Assay.
to:
The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

In USP Reference Standards 〈11〉/USP Azaerythromycin A RS: Change
734.96
to:
734.97
AND
In USP Azithromycin N-oxide RS: Change
764.98
to:
765.00
AND
In USP N-Demethylazithromycin RS: Change
734.96
to:
734.97
AND
In USP Desosaminylazithromycin RS: Change
590.79
to:
590.80

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.

In Organic Impurities, Procedure 2/footnote 4: Change
5-[[3-[[3-[[[3-[[3-[[3,5-Bis-[[[2,3-dihydroxypropyl]amino]carbonyl]-2,4,6-triiodophenyl](acetylimino)]-2-hydroxypropyl](acetylimino)]-5-[[[2,3-dihydroxypropyl]amino]carbonyl]-2,4,6-triiodophenyl]carbonyl]amino]-2-hy droxypropyl]oxy]-2-hydroxypropyl](acetylimino)]-N,N'-bis(2,3-dihy droxypropyl)-2,4,6-triiodo-1,3-benzendicarboxamide.
to:
5-[[3-[[3-[[[3-[[3-[[3,5-Bis-[[[2,3-dihydroxypropyl]amino]carbonyl]-2,4,6-triiodophenyl](acetylamino)]-2-hydroxypropyl](acetylamino)]-5-[[[2,3-dihydroxypropyl]amino]carbonyl]-2,4,6-triiodophenyl]carbonyl]amino]-2-hydroxypropyl]oxy]-2-hydroxypropyl](acetylamino)]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzendicarboxamide.

Change
Proceed with Injection as directed in the Assay for lidocaine hydrochloride under Lidocaine and Epinephrine Injection.
to:
Proceed with Injection as directed in the Assay for lidocaine hydrochloride under Lidocaine Hydrochloride and Epinephrine Injection.

Change
Prepare this solution by one of the following procedures:
to:
Prepare this solution by one of the following procedures. Apply the Test for sensitivity to confirm suitability for freshly or previously prepared solutions or commercially bought solutions.
AND
In Storage: Delete
Use the Test for sensitivity to confirm suitability for use.
AND
In Procedure with No Preservative: Delete
Apply the Test for sensitivity to confirm suitability for freshly or previously prepared solutions.
AND
In Test for sensitivity: Delete
Use the Test for sensitivity to confirm suitability for use.
AND
In Procedure with Salicylic Acid as Preservative: Change
Mix 1 g of soluble starch with 50 mL of cold water
to:
Mix 1 g of soluble starch with 5 mL of cold water

In Procedure/System suitability/Suitability requirements: Change
Resolution: NLT 3 between telmisartan and telmisartan related compound A
Tailing factor: NMT 2.0 for the telmisartan peak
Capacity factor: NLT 1.5
Relative standard deviation: NMT 2.0%
to:
Resolution: NLT 3 between telmisartan and telmisartan related compound A
Tailing factor: NMT 2.0 for telmisartan
Relative standard deviation: NMT 2.0% for telmisartan

In USP Reference Standards 〈11〉/USP Iodixanol Related Compound E RS: Change
5-[[3-[[3-[[(2,3-Dihydroxypropyl)amino]carbonyl]-5- [[amino]carbonyl]-2,4,6-triiodophenyl](acetylimino)]-2-hydroxypropyl]-(acetylimino)]-N,N′-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide.
to:
5-{N-[3-(N-{3-Carbamoyl-5-[(2,3-dihydroxypropyl)carbamoyl]-2,4,6-triiodophenyl}acetamido)-2-hydroxypropyl]acetamido}-N¹,N³-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide.

Change
Uniformity of Dosage Units 〈905〉
Procedure for content uniformity
to:
Uniformity of Dosage Units 〈905〉: Meets the requirements
Procedure for content uniformity, chewable tablets only
AND
In Uniformity of Dosage Units: Delete
Acceptance criteria: Meet the requirements for chewable tablets

In Dissolution 〈711〉/Test 1/Analysis: Change
Determine the percentage of telmisartan (C₃₃H₃₀N₄O₂) dissolved:
Result = (A_U × C_S × V × 100)/(A_S × D × L)
to:
Calculate the percentage of the labeled amount of telmisartan (C₃₃H₃₀N₄O₂) dissolved:
Result = (A_U/A_S) × C_S × V × D × (1/L) × 100
AND
Change
C_S = concentration of the Standard solution (mg/mL)
to:
C_S = concentration of USP Telmisartan RS in the Standard solution (mg/mL)
AND
In Dissolution 〈711〉/Test 2/Analysis: Change
r_U = peak response from the Sample solution
r_S = peak response from the Standard solution
to:
r_U = peak response of telmisartan from the Sample solution
r_S = peak response of telmisartan from the Standard solution
AND
In Dissolution 〈711〉/Test 3/Analysis: Change
C_S = concentration of the Standard solution (mg/mL)
to:
C_S = concentration of USP Telmisartan RS in the Standard solution (mg/mL)

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

In System suitability: Change
Samples: System suitability solution, Standard solution A, and Standard solution B
to:
Samples: System suitability solution and Standard solution A
AND
In Analysis: Change
Samples: Mobile phase, Standard solution A, and Sample solution
Chromatograph the Standard solution and adjust the integration parameters so that the response is 5%–15% of full-scale deflection.
to:
Samples: Mobile phase, Standard solution A, Standard solution B, and Sample solution
Chromatograph Standard solution B and adjust the integration parameters so that the response is 5%–15% of full-scale deflection.

In Test 1: Change
Buffer stage
Medium: 0.05 M pH 6.8 phosphate buffer (see Reagents, Indicators, and Solutions—Buffer Solutions)
to:
Buffer stage
Medium: 0.05 M pH 6.8 phosphate buffer (see Reagents, Indicators, and Solutions—Buffer Solutions); 900 mL

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 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