Product Name

Oseltamivir phosphate

Ref. standard

In-house standard

Batch No.:

060201

Certificate No.:

0001

Manu.Date

Jan.10,2006

Retest date

Jan.09,2008

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%

0.04%

Heavy metals

≤ 0.002%

< 0.002%

Specific rotation

[ a] D 23 °C,C=1 in water

(on anhydrous basis)

-30.0 ° ~ -40.0 °

-33.6 °

Residual solvents

Toluene: Not more than 0.089%

Ethanol: not more than 0.3%

Conform

Assay

98.0% ~ 102.0%

99.4%

Related substance

Impurity Ro-1637: ≤ 0.03%

Any single impurity: ≤ 0.5%

Total impurities: ≤ 1.0%

0.01%

0.30%

0.42%