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Bulk Active : Ibuprofen lysinate
MOLECULAR FORMULA : C13H18O2.C6H14N2O2
MOLECULAR WEIGHT : 352.47
Pharmacologic Activity :
NSAID
CAS No : 57469-76-8
Specifications : In-House
Regulatory compliance : eDMF(CTD)
| TEST | BP(vet) |
| DESCRIPTION | White powder |
IDENTIFICATION IR Melting range Angle of optical rotation |
Infrared absorption spectrophotometry to compare with the spectrum obtained with Reference Standard 178.0° to 182.0°C -0.10 to + 0.10° |
| Clarity of solution a) 1%w/v Solution in water b) 15%w/v solution in Methanol |
Clear Clear |
| pH of 1%w/v aqueous solution | 6.0-8.0 |
| Heavy metals |
Not more than 10 ppm |
| Loss on drying | NMT 0.5% w/w |
| Residue on ignition ( Sulphated ash) | NMT 0.20%w/w |
| Assay(Titrimetry) | Between 98.5% and 101.5% w/w |
| Lysine content (titrimetry) | 40.0-43.0% w/w |
| Ibuprofen content( by HPLC) | 57.0-60.0% w/w |
| Related Substance by HPLC) a) Unidentified impurity b) Total impurity |
NMT 0.10% NMT 0.50% |
