| Test items |
Standards |
|
Appearance
|
White off-white powder |
|
Odor
|
No special odour |
|
Purity(By Hplc)
|
≥99%
|
|
[a]3(c=1,H2O)Optical rotation
|
≥(+)122°
|
|
pH
|
6.0-7.5
|
| Melting point |
249-255℃
|
|
Loss on drying
|
≤0.5%
|
| Solvent residue (ethanol) |
≤300mg/kg
|
|
Heavy Metals
|
≤10ppm
|
|
Microbiology
|
total number of bacterial colonies ≤100cfu/g |
| Total moulds yeasts ≤10cfu/g |
| Heat-resistant coliforms not detectable |
| Staphylococcus aureus not detectable |
| Pseudomonas aeruginosa not detectable |
|
Storage
|
Store with seal away from light at 2~8℃, especially at-20℃
|