Artesunate Injection 60mg:
This pack also contain:
1ml sodium Bicarbonate injection BP 5% W/V & 5ml Sodium
BP 0.9% W/V
Refer Batche details on respective Ampoules.
INSTRUCTION FOR RECONSTITUTION:
Add B to A and mix well until the solution becomes clear.
0.9% W/V Sodium chloride Injection BP
For IV use:
- Add 5ml of sodium chloride injetion BP0.9% w/v to vial.
- Inject by slow IV route over 2-3 minutes.
- Do not put the solution in an IV drip.
For IM use:
- Add 2ml of sodium chloride injection BP0.9% w/v to the vial.
- Inject by IM route
As directed by the physician.
Store below 30℃ in dry place, protect from light.
For single use.
Keep out of reach of children.
See package insert fort complete prescribing information.
The reconsbitution solution should be stored below 30℃ and should be used within 1hour.
Certificate of Analysis
|Product||Artesunate Injection||MFG. Date||May 01, 2016|
|Specification||50mg||Report Date||May 06, 2016|
|Batch No.||160501||Expiry Date||May, 2019|
|Characteristics||White round tablet||White round tablet|
A. The infrared absorption spectrum is concordant with the spectrum
obtained from artesunate RS or with the reference spectrum of
|B. Add hydroxylamine hydrochloride TS2 and sodium hydroxide TS.
Heat the mixture in a water-bath to boiling, cool, add 2 drops of
hydrochloric acid TS and 2 drops of ferric chloride TS; a light
redviolet colour is produced.||Positive reaction|
|Related substances||Total impurities≤2.0%; single impurity≤1.0%, among them, no more
than one impurity peak ＞0.5%||Conforms|
Bacteria: ≤1000 CFU/g;
Fungi: ≤100 CFU/g;
E. coli should not be Negative.
Bacteria: 10 CFU/g
Fungi: 7 CFU/g
E. coli: Negative
|Conclusion:||Conform to: CP 2005|