1.Product Introduction:

Product name: Isotretinoin

CAS. no.:  4759-48-2

Chemical name:  3, 7-dimethly-9-(2, 6-trimethly-1-cylohexane)-2, 4, 6, 8-pelartetaenoic acid

Character: Yellow powder, trans tretionoirum mainly. Easily dissolved in chloroform, dichoromethane and dissolved in carbinol, ethanol and also dissolved in vegetable oil and lipid. Instability exposed in light and caloricr, easily absorbing moisture and metamorphosed in water. 

Quality index: Conform CP2005/BP2002/USP26

Melting point: about 182 centigrade

Loss on drying: ≤0.5% 

Heavy metals: ≤0.002%

Content: ≥98~102%

2.Main Function

1. It is a drug commonly used to treat acne vulgaris and keratosis pilaris.

2. It is available as a cream or gel. It is also used to treat acute promyelocytic leukemia.

3. It can stimulate skin growth and keep epidermic normal.

4. It can slow down skin aging process for solarization, remove tiny wrinkles.

5. It can reduce skin roughness, so skin will become ruddy.

3.Application

1. Isotretinoin is widely applied in pharmaceutical field, mainly used for the cure of dermatonosus like acne, ichthyosis and psoriasis abnormal, etc..

2.Isotretinoin can be made into tretinoin or retinoic acid cream to cureacne or other unhealthy skin.

3.Isotretinoin is used for skin keratinocytes-resistant drugs and cell-induced differentation drug.

4.Specification

Test/Observation	Specifications	Result
Assay Content HPLC	97%-102%	99.12%
Appearance	Fine Powder	Complies
Identification	IR. UV	Complies
Odor	Characteristic	Complies
Mesh	100% pass 100 mesh	Complies
Residue on ignition	MAX 0.1%	Complies
Loss on drying %	MAX 0.5%	0.39%
Ash %	MAX. 1.0%	0.52%
Heavy metals PPM	MAX. 0.002%	Complies
Limit of Isotretinoin	MAX5.0%	3.9%
Organic Volatile Impurities	Meet the Requirements	Complies
Microbiology   Total Plate Count   Yeast & Mold   E. Coli   Salmonella	< 1000cfu/g   < 100cfu/g   Negative   Negative	82cfu/g   Negative   Complies   Complies
Conclusion	Conform with specification

 

5. Product Packaging

0.5kgs/Al-foil bag

1.0kgs/Al-foil bag

2.0kgs/Al-foil bag

5.0 kgs/Al-foil bag

25.0 kgs/drum or upon customers' request