Approx. Rs 50 / vial
Limits as per IHS
Clear and colourless solution filled in amber type I glass ampoules having white ring on neck with label and sealed
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
Between 7.0 to 8.5
Should be free from particulate matter
Should be sterile
NMT 31.3 USP EU/ mg of dexamethasone phosphate
Each ml contains:
Dexamethasone Sodium Phosphate USP eq to Dexamethasone Phosphate
90.0% to 115.0% of L A
Approx. Rs 75 / Pack
SPECIFICATION AS PER USP
A white coloured, round shaped, biconvex film coated tablet plain on both sides.
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
6.10 mm ± 0.2 mm
3.10 mm ± 0.2 mm
NMT 30 min in water at 37???
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
|Description||a white to off-white powder|
a) By HPLC
b) By I.R. Absorption
The retention time of Orlistat peak in the sample chromatogram of assay test should match with that of laboratory standard.
The IR Spectrum of sample should be concordant with that of the laboratory standard.
|Melting Range||Between 40°C to 48°C|
|Water content(by KF Titration)||NMT 1.00% W/W|
|Specific Optical Rotation ||Between -30.0° and -40.0°|
|Residue on Ignition||NMT 0.20% W/W|
|Heavy Metals||NMT 0.002% (20 ppm)|
|Related substances (by HPLC )||Isopentyl Analog|
Any other single maximum impurity
|Assay Content of Orlistat(by HPLC)||Between 95.0% W/W and 100% W/W|
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Yashica Pharmaceuticals Private Limited