Identification Specification Result
Appearance: White crystals or crystal powder White crystals
Taste: Sweet, no odor Sweet, no odor
Solubility: Clear Clear
Assay %: 98.5-101.0 99.88
Other polyols %: ¡Ü1.0 0.11
Reducing sugar %: ¡Ü 0.20 0.02
Water % ¡Ü0.50 0.14
Residue on ignition %: ¡Ü 0.10 0.01
Melting point: 92.0-96.0 94.3
Heavy metal ppm: ¡Ü 10 <10
Lead ppm: ¡Ü 1 <1
Nickel ppm: ¡Ü1 <1
Organic Volatile impurity Conforms to NF Conforms
Identification A and B To pass test Conforms
Total bacteria cfu/g ¡Ü1000 <10
Mould and yeast cfu /g ¡Ü500 <10
E. Coli Negative None
Conclusion FCCIV/USP28