Steroidal Products

Test

Limits as per IHS

Description

Clear and colourless solution filled in amber type I glass ampoules having white ring on neck with label and sealed

Identification (TLC)

The retardation value of principal spot obtained from the test specimen corresponds to that obtained from the reference standard.

Average volume of 10 Container

Not less than 1.0 ml

Colour and Clarity of Solution

It should be clear and colourless solution

Nominal Volume

1.0 ml

pH

Between 7.0 to 8.5

Particulate Matter

Should be free from particulate matter

Sterility test

Should be sterile

Bacterial Endotoxin

NMT 31.3 USP EU/ mg of dexamethasone phosphate

Assay by

Each ml contains:

Dexamethasone Sodium Phosphate USP eq to Dexamethasone Phosphate

90.0% to 115.0% of L A

TEST

SPECIFICATION AS PER USP

Description

A white coloured, round shaped, biconvex film coated tablet plain on both sides.

Identification:

1. By IR

2. Identification B

Should comply as per USP

1. The IR spectrum of test should be concordant with reference spectrum.

2a. An orange colour should be produced

2b. A bluish green colour should be produced.

Average Weight of 20 Tablets

103.00 mg ± 3%

Uniformity of weight

Within ± 7.5% of average weight

Diameter

6.10 mm ± 0.2 mm

Thickness

3.10 mm ± 0.2 mm

Disintegration Time

NMT 30 min in water at 37???

Dissolution

NLT 80% (Q)

Uniformity of Content

85% to 115%

Assay (HPLC): Each Film coated tablet contains: Prednisone USP 5 mg

90.0% to 110.0%

4.5 mg to 5.5 mg