Product Name Artesunate Cas No 88495 63 0 Api Bulk Drugs Manufacturer Suppl - Indiaprice: contact company for price
Product Name Artesunate CAS No: 88495- 63- 0
Batch No: ART/ 011114 A. R. No 14/ FP/ ART/ 0111
Date of Manufacture Nov- 2014 Date of Analysis
02- 11- 14
Batch Quantity 100 kg Date of Retest Jan- 2017
Sr. No Test Results Acceptance Criteria
1. Appearance Complies A white
crystalline powder, odourless, almost tasteless.
( 1) Color reaction
( 2) Color reaction
The solution a red colour is produced
The solution a purple colour is produced
3. Solubility Complies Freely soluble in
ethanol, in acetone and in chloroform; very slightly
soluble in water.
4. Melting Point 134.8ºC to 135.6℃ 132ºC to
5. Specific Rotation 5.2° +4.5°~ +6.5°
( c=25mg/ ml Dichloromethane)
6. ( 3) Liquid chromatogram Complies The
retention time of the principal peak of the substance
being examined in the chromatogram obtained in the Assay
is identical with that of artesunate CRS in the
chromatogram of the reference solution.
7. ( 4) IR identify with the reference spectrum
Should be concordant with the reference spectrum
8. Acidity 4.5 3.5 to 5.0
9. Clarity and colour of
solution Complies Should comply with the
10. Chloride Complies Should comply
with the specification
11. Related substances
0.45% , no impurity detected between 0.5% ~1.0% .
NMT 0.5% , and impurity detected between 0.5% to 1.0%
should not more than one.
12. Water 0.25% NMT 0.5%
13. Residue on ignition 0.03% NMT 0.1%
14. Heavy metals Complies NMT 0.002%
15. Assay 99.2% 98.0% to 102.0%
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