- E-mail : info@wellonapharma.com
- Call : +91-261-2571244
- Mob: +91-7490041245
Isotretinoin is used primarily for severe cystic acne and acne that has not responded to other treatments. Acne treatment usually begins with topical retinoids (e.g., tretinoin, adapalene), in combination with topical antibiotics (e.g., clindamycin, erythromycin) or antiseptics (e.g., benzoyl peroxide-containing preparations), followed by oral antibiotics (e.g., doxycycline or minocycline). In women a cyproterone acetate-containing contraceptive pill can be useful if there are no contraindications.
Specification:
|
Items |
Standards |
Results |
|
Appearance |
Yellow crystals |
Yellow crystals |
|
Soluble in trichloromethane, sparingly solube in ethanol, isopropanol and polyethylene glycol, practically insoluble in water |
conforms |
|
|
Identification |
IR: the infrared absorbance spectrum is concordant with the reference standard spectrum |
Conforms |
|
UV:Absorptivities at 354nm do not differ by more than 3.0%(calculated on the dried basis) |
0.5% |
|
|
Loss on drying |
NMT0.5% |
0.13% |
|
Residue on lgnition |
NMT0.1% |
0.05% |
|
Heavy Metal |
NMT0.002% |
<0.002% |
|
Limit of tretinoin |
NMT1.0% |
0.13% |
|
Residual solvents |
Ethanol ≤5000ppm |
1349ppm |
|
Purity(HPLC) |
Calculated on the dried basis |
99.3% |
Packaging details:
|
Packaging details: |
25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
|
Storage: |
Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
|
Shelf Life: |
5 years if sealed and store away from direct sun light. |
