-
- Posts: 3
- Joined: Sun Nov 20, 2011 10:29 am
Dear sir,
I have one doubt on For Injection Accurcy validation:
I have 40 mg/Vial and 2000 g/vial
Procedure For 40 mg/Vial:Take 5 Vials and each vial reconstitute with 1 mL of water and pooled the sample from the take 2 ml to 20 and from this solution take 3 to 50 ml
Procedure For 2000 mg/Vial:Take 3 Vials and each vial reconstitute with 30mL of water and pooled the sample from the take 2 ml to 20 and from this solution take 2 to 50 ml
Above mentioned both strengths are having different placeboes so we need to perform the accuracy for both the strengths
Please sugeest how to do the accurcy both are lifelized vials
bulk solution concentration for 40 mg/Vial is 20 mg/mL In each vial 2 ml
bulk solution concentration for 200 g/Vial is 62.5 mg/mL In each vial 32 ml
Regards,
ashokreddy
I have one doubt on For Injection Accurcy validation:
I have 40 mg/Vial and 2000 g/vial
Procedure For 40 mg/Vial:Take 5 Vials and each vial reconstitute with 1 mL of water and pooled the sample from the take 2 ml to 20 and from this solution take 3 to 50 ml
Procedure For 2000 mg/Vial:Take 3 Vials and each vial reconstitute with 30mL of water and pooled the sample from the take 2 ml to 20 and from this solution take 2 to 50 ml
Above mentioned both strengths are having different placeboes so we need to perform the accuracy for both the strengths
Please sugeest how to do the accurcy both are lifelized vials
bulk solution concentration for 40 mg/Vial is 20 mg/mL In each vial 2 ml
bulk solution concentration for 200 g/Vial is 62.5 mg/mL In each vial 32 ml
Regards,
ashokreddy
