Re: Analysis of the analytical sample in duplicate

["msn mail" <rps_pan@hotmail.com>(by way of John Dolman<moderator@the-dolman-consultancy.com>)]

Dar Malcolm Ross,
Thanks for valuable guidance.  This is again a question for me when
a HPLC method is validated (for which accuracy and precision is obviously
high than other analysis), analyst is validated.  Additionally the
analytical method is official in the pharmacopoeia then how to decide
either to prepare the samples in, 
1.  Duplicate standard and test preparations and multiple
injections
2.  or single standard and test preparation and multiple
injections
 
What could be the probability for the above
cases?  or any guideline to decide for the above criteria.
 
Regards,
 
Rupesh Sakhare 
 
From:
Malcolm Ross
(by way of John Dolman <moderator@the-dolman-consultancy.com>)
Sent: Friday, February 22, 2008 10:18 AM
To: GMP Forum 
Subject: Re: Analysis of the analytical sample in
duplicate

The answer has nothing to do with the BP-the answer is in the accuracy
and precision of your method as related to your equipment. For example
the more sensitive the analytical balance the less material needs to be
weighed. On the other hand the number of dilutions and the volume of
pipettes. flasks etc. all have a critical effect on accuracy.

So their is no simple plug in answer-you must understand the analytical
constraints of your method.

Malcolm Ross
Generapharm-training and consultancy
Basel-CH

On Fri, Feb 22, 2008 at 11:13 AM, msn mail
<rps_pan@hotmail.com>
wrote:

Dear all,

Please someone can tell me how much samples are required to prepare the standard and test sample

for HPLC assays as per the BP.

Is there any guidelines available to specify such requirement for EU market.

Regards,

Rupesh Sakhare

 

 

-- 
Malcolm Ross
Generapharm-Training and Consultancy
Rümelinbachweg 16
Basel 4054
Switzerland
+41 615 34 64 18