Erythromycin Stearate Tablets

Test

Limits as per BP

Description

Pink coloured round shaped biconvex film coated tablet, with break-line on one side plain on other side.

Identification:

IR Absorption:

Colour Development:

Precipitation Method

Should comply as per BP

The IR absorption spectrum of the test residue should be concordant with reference spectrum of erythromycin stearate.

The chloroform layer should be violet.

A granular precipitate should be produced which is insoluble in Hydrochloric Acid

Average weight of 20 Tablet

550.00 mg ± 5%

Uniformity of Weight

± 5.0% of average weight

Thickness

4.80 ± 0.20 mm

Diameter

12.80 mm ± 0.10 mm

Disintegration Time

NMT 30 min

Dissolution

NLT 70%

Assay: Each film-coated tablet contains Erythromycin Stearate BP eq. to Erythromycin Base 250 mg

97.0% to 110.0% of L A

(242.50 mg to 275.0 mg)