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Isotretinoin Manufacturing Thailand, the United Kingdom and USA
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Isotretinoin

  • Product Name : Isotretinoin
  • Grade : IP / BP / USP
  • Therapeutic Category : Antiacne
  • CAS No : 4759-48-2
  • COA : Available
  • MSDS : Available

Description

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.

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