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ACTIVE PHARMA INGREDEINTS SPECIFICATION

Bisacodyl B.P / USP
Specification For : Bisacodyl B.P
Test Specification
Description White Crystalline Powder
Solubility Practically insoluble in water, soluble in acetone, sparingly soluble in alcohol, slightly soluble in ether. It dissolves in dilute mineral acids
Identification A) Melts between 131°C-135°C
B) U.V. Absorption
C)IR
D) TLC- Complies.
Acidity or Alkalinity NMT 0.4 ml of 0.01M HCl required to change the colour.
Related substance(TLC) Should be single spot
Sulphated Ash Limit : Max. 0.1%
Loss on Drying[100°C-105°C] Limit : Max. 0.5%
Assay Limit: 98 % to 101%
(On Dried Basis)

Eosin Disodium FRP
Specification For : Eosin Yellow Sodium Salt FRP
Test Specification
Description Brownish red powder
Identification A. Test Passes
B. Test Passes
C. Test Passes
D. Test Passes
E. Test Passes
Solubility 0.1 %( In Water) Clear reddish yellow solution
Absorptivity (A1%,1CM Water λ max) Limit :1200-1400
Absorption Maximum (Water λ max) Limit : 515-518 NM
Combined ether extracts Mass of residue : Max.0.5%
Related Substances Complies
Chloride Limit : Max. 1%
Sulphated Ash Limit : 20 to 23%
Insoluble Matter Limit : Max 0.2 %
Loss On Drying (At 110 0C 1HR) Limit : Max 8%
Ether Limit : Max.0.5%
Assay Limit : Min. 87 %
pH (a 2% solution in distilled water) Limit : 7.0 to 8.0
Lead (as Pb) Limit : Max. 20 PPM
Arsenic (as As) Limit : Max. 3 PPM


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