CERTIFICATE OF ANALYSIS
W*IsoteX (Isotretinoin)
BATCH NO: 060102
MANUFACTURING DATE: 02 JAN.2006
EXPIRY DATE: 01 JAN.2008
| ITEMS | SPECIFICATION | TEST RESULTE |
| 1. Characters: | yellow or light orange crystalline powder | comply |
| 2. Identification: a: b: |
UV IR |
comply comply |
| 3. Related substances: Tretinoin: Total of other impurity: Heavy metals: Loss on drying: Sulphated ash: Assay: Residul solvent (ethyl acetate): |
2.0% max 0.5% max 20ppm max 0,5% max 0.1% max 98%102% 5000ppm max |
0.5% 0.4% 20ppm max 0.15% 0.03% 99.2% 1675ppm |
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