Specification:
Appearance:White crystalline powder/granule.
Assay (Titrimetric):98.0% to 102.0% (dried basis.)
Specific Rotation[α] D:+14.5° to +16.5°
Loss on Drying:4.5% max
Residue on Ignition (Sulphated Ash):0.2% max
Diketopiperazine (5-Benzy1-3, 6-Dioxo-2-Piperazineacetic Acid):1.5% max
Organic Volatile Impurities:In conformity with EP2000
Other Related Substances:2.0% max
Transmittance:95.0% min.
Heavy Metals (As Pb) :10 ppm max
Lead ( Pb):1 ppm max
Arsenic (As):3 ppm max
Conductivity:30 (μ Mhos/cm) max
PH:4.5 to 6.0 units
L-α-Asparty1 L-Phenylalanine : 0.25% max.
L-Phenylalanine:0.5% max.
Total Aerobic Count: 100 CFU/g max
Moulds and Yeasts: 100 CFU/g max
E. Coli Negative
Salmonella S.D. Negative
Packaging: 25 kg net weight carton boxes or fiber drums with inner liner;.