kaushal09
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India,
2008-07-19 10:32
(6555 d 15:19 ago)

Posting: # 2062
Views: 4,255
 

 ANVISA requirement for stability study [Regulatives / Guidelines]

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Dear HS,

Can you give me suggesion or any reference to perform experiment of stability study during Method validation like Short term stock solution , Bench top stability or Auto sampler stability etc.

Thanks and regards

Kaushal ;-)
 
Helmut
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Vienna, Austria,
2008-07-19 17:59
(6555 d 07:52 ago)

@ kaushal09
Posting: # 2064
Views: 3,636
 

 ANVISA requirement for stability study

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Dear Kaushal,

please see this post first - just for the future... ;-)
The guidance page would have lead you to this document.

❝ [...] stability study during Method validation like

❝ Short term stock solution,

  --> Section 3.6.9.1.

❝ Bench top stability

  --> Section 3.9.3.

❝ Auto sampler stability

  --> Section 3.9.5.
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