Ketoprofen Lysinate
 

MOLECULAR WEIGHT: 400.47 MOLECULAR FORMULA: C16H14O3.C6H14N2O2

alendronate sodium

Tests In House Specifications
Description White or almost white powder
Solubility Freely soluble in water.Practically insoluble in most of Organic solvents.
IDENTIFICATION
IR  TLC
  Infrared absorption spectrophotometry to compare with the spectrum obtained with Reference Standard
To compare with corresponding reference spot
Melting range 161.0°    to 165.0°C
Specific absorbance Absorbtion maximum at 260 nm.Specific absorbance between 395 and 425(dried substance)
Specific optical rotation -0.2º  to +0.2º for 5% solution in purified water.
pH 6.5-7.5
Heavy metals Not more than 20 ppm
Loss on drying NMT 2.0% w/w
Sulphated ash NMT 0.20%w/w
Sulphates NMT 200ppm
chlorides NMT 300ppm
Related Substance  by HPLC)
Single impurity
Total Impurity
NMT 0.2%
NMT 1.0%
Assay  ( On dried basis) Between 98.0% and 102.0% w/w

 

 

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