نیتیزینون

NITIZINONE

International non-proprietary name (INN):
NITISINONE


Chemical Abstract Index name:
۲-[۲-nitro-4-(trifluoromethyl)benzoyl] cyclohexane-1,3-dione


CAS Registry No :
104206-65-7

Indication:
Hereditary tyrosinaemia type 1.Nitisinone is under investigation for the treatment of alkaptonuria

Structure

Physical form and appearance : White to cream powder

Physical state: Solid

Form: Powder

Molecular weight: 329.2 g/mol

Molecular formula: C14H10F3NO5

Identification: HPLC

Assay (HPLC): 99-101% w/w

Solubility: Insoluble in water, Slightly Soluble in
Methanol, Soluble in aqueous alkali hydroxide (NaOH).

Storage: Keep container tightly closed and store in
a refrigerator. Protect from light.

Technical specification:
(HPLC): 99.5%
Purity (HPLC): ≥۹۹٫۵%

Related substance (HPLC)

Individual impurity ≤ ۰٫۵۰%

Total impurities ≤ ۱٫۰۰%

Method: In-House method as per ICH


Guidelines :