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Home » Products » Speciality Chemicals » Amiodarone

Amiodarone

Amiodarone
Amiodarone
Product Code : 8987
Brand Name : Niranjan Laboratry
  • Minimum Order Quantity
Trade Information
  • Main Domestic Market
  • All India
Product Description

Specifications:

Sr.No. Test Specification
1 Description  A White or almost white fine crystalline powder.
2 Solubility Soluble in methylene chloride and methanol;
 
3 Identification :
By IR
The Infrared absorption spectrum of substance being examined must be concordant with the IR spectrum obtained from Amiodarone Hydrochloride RS.
Reaction of chloride Gives the reaction of chlorides
4 Appearance of solution Solution is clear and not more intensely colored than reference solution GY5 or BY5
5 pH (5% w/v solution in carbon dioxide free water, (25°C) Between 3.2 to 3.8
6 Impurity H (By HPLC)   Not more than 0.01%
7 Related substances (By
HPLC)
Amiodarone impurity  A
Amiodarone impurity  B
Total impurities
 
 
Not more than 0.20%
Not more than 0.20%
Not more than 0.50%
8 Iodides Not more than 150 ppm
8 Heavy metals Not more than 20 ppm
9 Loss on drying Not more than 0.5 % w/w
10 Sulphated ash Not more than 0.1 % w/w
11 Assay By Titrimetry
(on dried basis)
Not less than 98.5 %w/w and not more than  101.0 %w/w
12 Residual solvents (By GC)
Toluene
Isopropyl alcohol
 
Not more than 100 ppm
Not more than 4000 ppm

 

 


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