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Active Pharmaceutical Ingredient
Mesalamine

 

Product Name: Mesalamine
CAS NO.: 89-57-6
Description:

 

Items

Specification

Appearance:

White or off-white crystalline powder

Clarity of solution:

 

Identification

UV

Infrared absorption

NMR absorption

 

Similar to working standards

Similar to working standards

Similar to working standards

Assay:

98.5-101.5%

Residue on ignition:

Not more than 0.20%

Heavy metals:

Not more than 10ppm

Loss on drying:

Not more than 0.5%

pH value(in 1% solution):

3.5-4.5

Chloride:

Not more than 0.1%

Sulfate:

Not more than 0.2%

Hydrogen sulfide and sulfur dioxide:

Negative

3-aminosalicylic acid:

Not more than 0.2%

Aniline:

Not more than 5g/g

Phenol:

Not more than 5g/g

4-aminophenol:

Not more than 200g/g

2-aminophenol:

Not more than 200g/g

Total impurities:

Not more than 1%

Other single impurity:

Not more than 0.2%

 
 
 
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