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Active Pharmaceuticals

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  • COA

Name: Tretinoin (Vitamin A Acid, Retinoids)

Alias: Tretinoin

Other names: all-trans retinoic acid, retinoic acid, all-trans retinoic acid

Molecular formula: C20H28O2

Molecular weight: MW 300.44

Appearance: yellow or light orange crystalline powder

Content: 97.0–103.0%

Quality standard: USP32

Category: Anti-dermal keratinization drugs, cell differentiation drugs

Storage conditions: shading, sealed and preserved

Retinoic/Tretinoin is the acid form of vitamin A and is also known as all-trans retinoic acid or ATRA. It is a drug commonly used to treat acne vulgaris and keratosis pilaris. It is available as a cream or gel It is also used to treat acute promyelocytic leukemia. It is also available as a generic.

Its success in treating acute promyelocytic leukemia was a major breakthrough in the treatment of this type of leukemia.It works in APL because the majority of cases involve a chromosomal translocation of chromosomes 15 and 17, which causes genetic fusion of the retinoic acid receptor gene to the promyelocytic leukemia gene.
This fusion PML-RAR protein is responsible for preventing immature myeloid cells from differentiating into more mature cells. This block in differentiation is thought to cause leukemia.

ATRA acts on PML-RAR to lift this block, causing the immature promyelocytes to differentiate to normal mature blood cells thus decreasing promyelocytes.

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.

Standard adopted USP34
Items Specification Results
Appearance yellow crystalline powder Conforms
Identification Should comply with the provisions Conforms
Loss on drying ≤0.5% 0.20%
Heavy metals ≤0.002% Conforms
Residue on ignition ≤0.1% 0.03%
Limit Isotretinoin ≤5.0% 0.3%
Assay 98.0~102.0% 99.5%
Conclusion Qualified

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