Yashica Pharmaceuticals Private Limited
Thane, Maharashtra
GST 27AAACY3217A1ZT
TrustSeal Verified
IndiaMART Verified Exporter
Approx. Rs 12,000 / Kg
Description | a white to off-white powder | |
Identification 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 Dimethyl Orlistat Any other single maximum impurity Total Impurity | NMT 1.00% NMT 1.00% NMT 1.00% NMT 3.00% |
Assay Content of Orlistat(by HPLC) | Between 95.0% W/W and 100% W/W |
Approx. Rs 50 / vial
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 |
Approx. Rs 75 / Bottle
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 |
We will contact you soon !
Sanjay Totre
(Managing Director)
Yashica Pharmaceuticals Private Limited
Syndicate, Thane,
Maharashtra,
India