Isotretinoin accutane Isotrex Tretinoin Skin Care Acne Treatment Pharma Chemical

Isotretinoin accutane Isotrex Tretinoin Skin Care Acne Treatment Pharma Chemical

Isotretinoin accutane Isotrex Tretinoin Skin Care Acne Treatment Pharma Chemical

Isotretinoin
Other name: accutane;Isoretinoin;isotrex
CAS:    4759-48-2
MF:    C20H28O2
MW:    300.44
EINECS:    225-296-0
Melting point:    172-175 °C
Isotretinoin Water Solubility : insoluble.
Isotretinoin Stability: Stable, but air and light sensitive.Incompatible with strong oxidizing agents.
Isotretinoin Physical and Chemical Properties: Yellow or orange crystalline powder or crystal, insoluble in water, slightly soluble in ethanol, very slightly soluble in ether, soluble in chloroform.

USP34 Isotretinoin powder Chemical Test Specifications (COA):

Product name
A
Isotretinoin
CAS
CAS No.
4759-48-2
Outer Packing
100G
Production date
2016.12.03
Shelf life
2018.12.02
Standard adopted
USP34
USP34
Items of analysis
Specification
Results
Description
Yellow or orange crystalline powder
complies
complies
Identification
complies
complies
Loss on drying
Not more than 0.5%
0.04%
Residue on ignition
Not more than 0.1%
0.02%
Heavy metals
Not more than 0.002%
<0.002
Tretinoin
Not more than 1.0%
0.1%
Assay
98.0%~102.0 %
99.8%
Conclusion
Qualified

Isotretinoin Uses:
Vitamin A class drugs. It can rapidly and strongly inhibit the cell proliferation and differentiation process of skin glands cells. It has a high effect on severe nodular cystic acne. This product has a high gastrointestinal absorption, but invalid for topical administration. It is used for treating severe acnes which cannot be treated by other drugs. It also has some effects on treating cystic acne, the party of acne, rosacea, ichthyosis, follicular keratosis and pityriasis red hair and other skin diseases.

Isotretinoin belongs to the first generation of vitamin A acid. It is a stereoisomer of all-trans vitamin A acid. Oral administration has an anti-oil effect which has special effect on severe acne. The mechanism is as follows:
(1) it can reduce sebaceous gland and inhibit the activity of sebaceous gland, reducing the effect of secretion of the sebaceous glands, thus inhibiting the growth of Propionibacterium which relies on lipid environment.
(2) it has an anti-keratosis effect, can inhibit the excess proliferation of epidermal and promote its differentiation. It also reduces the keratosis of hair follicles and the catheter of sebaceous glands.
(3) it can also affect the function of lymphocytes and monocytes, and inhibit the chemotaxis of neutrophil, and thus having anti-inflammatory activity.
(4) it can exert its therapeutic effect by selectively binding Vitamin A acid nuclear receptors. It can inhibit the proliferation of acne rod bacilli. Moreover it has effects of immunity stimulation at low doses, but has immunity suppression effect at high doses.
(5) It can inhibit the biogenesis of collagenase and gelatinase in the skin, and can also inhibit the activity of ornithine decarboxylase. Owing to the major role of ornithine decarboxylase in inducing skin mutations, so isotretinoin can also suppress tumorigenesis.
(6) when subjects to topical administration, it has a similar mechanism of action as vitamin A acid which induces the proliferation of epidermal cell, promotes the differentiation of epidermal cell granular layer into the stratum corneum. It can also regulate the horny plug occurring during some abnormal cornification processes of Hair follicle sebaceous epithelium, and thus playing a therapeutic role.

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