auditor
★    

India,
2011-08-11 17:24
(5046 d 12:56 ago)

Posting: # 7279
Views: 4,143
 

 Failing of ISR [Bioanalytics]

Dear All,

kindly advice probeble reason for below mentioned incident:

in one of the my study the ISR meet the acceptance criteia about 60% and the whatever sample are not metting the acceptance are failing at negetive side (i.e the % diffrence is -25%, -30% etc). in this case i jsut want to know due to which reason the ISR samples are failing in negative side only. the samples which are meet the acceptance are also passing with the negative diffrence.

I am suspecting this may happen due to matrix effect whcih may arrives after some time. kindly advice, is this cause for failing my ISR or any other reason is there. :confused:

Regards

Auditor
ElMaestro
★★★

Denmark,
2011-08-11 18:05
(5046 d 12:14 ago)

@ auditor
Posting: # 7280
Views: 3,499
 

 Failing of ISR

Hi auditor,

can you explain your situation with other and more words?
It would be helpful for my understanding. And what exactly is your IS acceptance criterion?

Many thanks.
Helmut
★★★
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Vienna, Austria,
2011-08-11 23:41
(5046 d 06:39 ago)

@ auditor
Posting: # 7281
Views: 3,509
 

 Spelling (yet another time…)

Dear Auditor,

please (again and again): Read and follow this post.

You might have noticed that you got very few replies to your previous posts. One reason might be your sloppy spelling. If you want to be taken seriously try to invest some more time in formulating your questions in a way which is more easy to comprehend. THX.

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moblak
☆    

2011-08-22 14:57
(5035 d 15:22 ago)

@ auditor
Posting: # 7284
Views: 3,292
 

 Unstable analyte?

Hi Auditor,

❝ in one of the my study the ISR meet the acceptance criteia about 60% and the whatever sample are not metting the acceptance are failing at negetive side (i.e the % diffrence is -25%, -30% etc).


One of the reasons for the negative ISR difference could be that your analyte is not stable in biol. matrix due to degradation, hydrolysis, formation of metabolites such as lactones ...

Of course....taking into account that you are comparing ISR result to the original one:

%diff=100*(ISR-Orig)/Orig or %diff=200*(ISR-Orig)/(ISR+Orig)


Regards
moblak
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