Analytical | Result | Specification (EP/BP2011/USP32) |
Acidity or Alkalinity (10% w/w in etoh 96%) | 0.45ml | not more than 0.5ml of 0.01m NaOH (EP/BP2011) required to change colour to pink. (EP/BP2011 |
Specific optical rotation | -49.50o | -48 o to -51 o (EP/BP2011)/ -45 o to -51 o (USP32) |
Average melting point | 42.40 oC | about 43oC (EP/BP2011)/ 41o to 44oC (USP32) |
Residue on evaporation | 0.03% | not more than 0.05% (EP/BP2011/USP32) |
Appearance of solution | complied | solution is clear and coulourless (EP/BP2011) |
Heavy metals (lead, arscenic, mercury, cadmium) | complied | 10PPM max each |
Assay (by GC) | 99.41% | not less than 99% w/w. (EP/BP2011) not less than 97% w/w. (USP32 |
Related substances | complied | not more than 1% of the area of the principal peak (EP/BP2011) |
Residual solvents | complied | <467> under chemical tests section (USP32) |