Dear Min,
Depends on your SOP ,the method you are following.Both ways are OK.
Thanks and Regards
Usha Prasad
NESSO
-----Original Message-----
From: Pharmaceutical Stability Discussion Group
[mailto:[log in to unmask]] On Behalf Of Min He
Sent: 18 September 2012 04:44
To: [log in to unmask]
Subject: [PSDGLIST] PSDGLIST] How do you set up the bracket injection
acceptance criteria
Dear Colleagues,
I would appreciate your input regarding the acceptance criteria for bracket
injection in HPLC/GC testing. The sequence could be pretty long. We usually
insert a bracket injection every 20 injections. The bracket injection uses
the same standard solution as system suitability injections at the beginning
of the sequence.
Per USP, the %RSD should be used to evaluate the precision of the system.
Currently, we have two approaches:
1) Calculate the %RSD for the five system suitability plus the specific
bracket injection which should be no more than 2%
2) Calculate the %RSD for the five system suitability plus the bracket
injections performed so far, which should be no more than 2%.
For example, for the nth bracket injection, the %RSD is calculated using the
system suitability injections and the 1 to n bracket injections.
Which approach is more appropriate? (Assume the validation support both).
Thanks,
Min
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High quality controlled environmental walk-in rooms and reach-in chambers
Full installation, validation and spare parts also available
Environmental Specialties - http://www.eschambers.com/
Manufacturer of Quality Stability Chambers and
Provider of Complete Validation & Calibration Services
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