Azithromycin Tablets(阿奇霉素片) USP40

C S= concentration of USP Azithromycin RS in the Sample solution: Nominally 1mg/mL of azithromycin

Standard solution (mg/mL)in Mobile phase from NLT 20 Tablets, finely powdered.

C U= nominal concentration of azithromycin in Sonicate and shake as needed to dissolve.

Sample solution 1 (mg/mL)Chromatographic system

P= potency of azithromycin in USP Azithromycin(See Chromatography 〈621〉, System Suitability.) RS (µg/mg)Mode: LC

F= conversion factor, 0.001mg/µg Detector: UV 210 nm

Where packaged in a multiple-unit container Column: 4.6-mm × 25-cm; 5-µm packing L1

Calculate the percentage of the labeled amount of Column temperature: 50°

azithromycin (C38H72N2O12) in the portion of Flow rate: 2mL/min

Azithromycin for Oral Suspension taken:Injection volume: 100µL

System suitability

Result = (r U/r S) × (C S/C U) ×P×F× 100Sample:Standard solution

Suitability requirements

r U= peak response from Sample solution 2Tailing factor: NMT 2.0, Standard solution

r S= peak response from the Standard solution Relative standard deviation: NMT 2.0%, Standard

C S= concentration of USP Azithromycin RS in the solution

Standard solution (mg/mL)Analysis

C U= nominal concentration of azithromycin in Samples:Standard solution and Sample solution

Sample solution 2 (mg/mL)Calculate the percentage of the labeled amount of P= potency of azithromycin in USP Azithromycin azithromycin (C

38H72N2O12) in the portion of Tablets RS (µg/mg)taken:

F= conversion factor, 0.001mg/µg

Acceptance criteria: 90.0%–110.0%Result = (r U/r S) × (C S/C U) ×P×F× 100

PERFORMANCE TESTS r

U= peak response of azithromycin from the

•D ELIVERABLE V OLUME〈698〉: Meets the requirements Sample solution

•U NIFORMITY OF D OSAGE U NITS〈905〉r

S= peak response of azithromycin from the For single-unit containers Standard solution

Acceptance criteria: Meets the requirements C

S= concentration of USP Azithromycin RS in the

Standard solution (mg/mL)

SPECIFIC TESTS C

U= nominal concentration of azithromycin in the •P H 〈791〉Sample solution (mg/mL) For a solid packaged in single-unit containers:P= potency of USP Azithromycin RS (µg/mg)

9.0–11.0, in the suspension constituted as directed in F= conversion factor, 0.001mg/µg

the labeling Acceptance criteria: 90.0%–110.0%

For a solid packaged in multiple-unit containers:

8.5–11.0, in the suspension constituted as directed in PERFORMANCE TESTS

the labeling•D ISSOLUTION〈711〉

Medium: pH 6.0phosphate buffer; 900mL ADDITIONAL REQUIREMENTS Apparatus 2: 75 rpm

•P ACKAGING AND S TORAGE: Preserve in tight containers.Time: 30 min

•USP R EFERENCE S TANDARDS〈11〉Solution A: 4.4mg/mL of dibasic potassium phosphate USP Azaerythromycin A RS and 0.5mg/mL of sodium 1-octanesulfonate, adjusted 9-Deoxo-9a-aza-9a-homoerythromycin A;with phosphoric acid to a pH of 8.20 ± 0.05

6-Demethylazithromycin.Mobile phase: Acetonitrile, methanol, and Solution A C37H70N2O12734.96(9:3:8)

USP Azithromycin RS Diluent: 17.5mg/mL of dibasic potassium phosphate.

Adjust with phosphoric acid to a pH of 8.00 ± 0.05.

Prepare a mixture of this solution and acetonitrile

(80:20).

Standard stock solution: Dissolve USP Azithromycin RS Azithromycin Tablets in Medium to obtain a solution having a known concen-

tration of about (L/1000) mg/mL, where L is the Tablet DEFINITION label claim in mg.

Azithromycin Tablets contain NLT 90.0% and NMT 110.0%Standard solution: Dilute the Standard stock solution

of the labeled amount of azithromycin (C38H72N2O12).with Diluent to obtain a solution having a known con-

centration of about (L/2000) mg/mL, where L is the IDENTIFICATION Tablet label claim in mg.

•A. The retention time of the major peak of the Sample Sample solution: Pass a portion of the solution under solution corresponds to that of the Standard solution, as test through a suitable filter of 0.45-µm pore size. Di-obtained in the Assay.lute a portion of the filtrate with Diluent to obtain a

solution having a theoretical concentration of about ASSAY(L/2000) mg/mL, where L is the Tablet label claim in

•P ROCEDURE mg, assuming complete dissolution.

Buffer: Dissolve 4.6g of monobasic potassium phos-Chromatographic system

phate anhydrous in 900mL of water. Adjust with 1N(See Chromatography 〈621〉, System Suitability.)

sodium hydroxide to a pH of 7.5, and dilute with water

to 1L.

Mobile phase: Acetonitrile and Buffer (65:35)

Standard solution: 1mg/mL of USP Azithromycin RS in

Mobile phase. Sonicate and shake as needed to dissolve.