CAS NO: 22839-47-0
Specification: FCCIV
Appearance White crystalline powder.
Assay (Titrimetric) 98.0% to 102.0% (dried basis.)
Specific Rotation[α] D +14.5° to +16.5°
Loss on Drying ≤ 4.5%
Diketopiperazine (5-Benzy1-3, 6-Dioxo-2-Piperazineacetic Acid) ≤1.5%
. Residue on Ignition (Sulphated Ash) ≤ 0.2%
Organic Volatile Impurities In conformity with EP2000
Other Related Substances ≤2.0%
Transmittance 95.0% min.
Heavy Metals (As Pb) ≤ 10 ppm
Lead ( Pb) ≤1 ppm
Arsenic (As) ≤ 3 ppm
Conductivity (μ Mhos/Cm) ≤30 (μ Mhos/cm)
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
Moulds and Yeasts ≤ 100 CFU/g
. E. Coli Negative
Salmonella S.D. Negative