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KETOTIFEN FUMARATE BP2007

KETOTIFEN FUMARATE BP2007
Product Detailed
1. Standard:BP/EP 2. Packing:1kg/Tin; 5 Tins per Carton 3. Lead time:15-20 days after receiving the original L/C or paymen
Product NameKetotifen Fumarate
Quanlity Standard:BP2007
 
ITEMSPECIFICATION
Characters:White to brownish-yellow,fine,crystalline powder.
Identification:TLC
IR spectrum
Solubility:Sparingly soluble in water,slightly soluble in methanol,very slightly soluble in acetonifrile
Clarity and colour of solution:Clear and not more than Y4,BY4,B4
Loss on drying:Not more than 0.5%
Sulphated ash:Not more than 0.1%
Related substances(HPLC) 
      Impurity A:Not more than 0.2%
      Impurity G:Not more than 0.2%
      Single unknown impurity:Not more than 0.10%
      Total impurities:Not more than 0.5%
Residual solvents:

Acetone ≤5000PPM                                                   

Methanol ≤500PPM

Assay (potentiometic titration) Calculated on the dried basisBetween 98.5% and 101.0%

KETOTIFEN FUMARATE BP2007



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