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CERTIFICATE OF ANALYSIS 2 |
Product Name |
Oseltamivir phosphate |
Ref. standard |
In-house standard |
Batch No.: |
060202 |
Certificate No.: |
0002 |
Manu.Date |
Jan.15,2006 |
Retest date |
Jan.14,2008 |
Packing |
25kg/drum |
Quantity |
50kg |
ITEMS |
SPECIFICATIONS |
RESULTS |
Description |
A white or off-white powder |
Conform |
Solubility |
Soluble in water and methanol |
Conform |
Identification |
A: HPLC; B:IR.
|
Conform |
Loss on drying (105 °C - 3 hours)
|
≤ 0.5% |
0.08% |
Heavy metals |
≤ 0.002% |
< 0.002% |
Specific rotation [ a ] D 23 °C ,C=1 in water (on anhydrous basis)
|
-30.0 ° ~ -40.0 ° |
-33.1 ° |
Residual solvents |
Toluene: Not more than 0.089%
Ethanol: not more than 0.3%
|
Conform |
Assay |
98.0% ~ 102.0% |
99.7% |
Related substance |
Impurity Ro-1637: ≤ 0.03%
Any single impurity: ≤ 0.5%
Total impurities: ≤ 1.0%
|
0.01%
0.29%
0.45%
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CONCLUSION: COMPLIES WITH IN HOUSE STANDARD.
CERTIFICATE OF ANALYSIS 1
CERTIFICATE OF ANALYSIS 3
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