| ≥1 piece |
|
Items |
Specifications |
FCC V |
|
Appearance |
White crystalline powder |
White crystalline powder |
|
Assay (calculated with reference to the dried substance) |
98.0-102.0% |
98.0%-102.0% |
|
Specific Rotation |
+84.0°-- +87.5° |
+84.0°-- +87.5 |
|
Moisture |
≤2.0%. |
≤2.0% |
|
PH of 10% Aqueous Solution |
5~8 |
-- |
|
methanol |
≤0.1%. |
≤0.1% |
|
Arsenic (As) |
≤3mg/kg |
-- |
|
Lead |
≤1mg/kg. |
≤1mg/kg |
|
Ignited Residue |
≤10mg/kg |
-- |
|
Hydrolysis Products |
≤0.7% |
-- |
|
Related Substances |
Passes test |
Passes test |
|
Total aerobic count |
Passes test |
Passes test |
|
E.coli |
250 cfu/g |
-- |
|
S.aureus |
Negative |
-- |
|
Salmonella |
Negative |
-- |
|
Yeasts & Moulds |
50 cfu/g |
-- |
|
Conclusion |
The quality in conformity with the FCC V and USP30 |
|