stability sample analysis

[ajaib5]

Dear All

Can anyone tell me the acceptable time windoe for the analysis of stability sample after withdrawl. eg if the sample is withdrawn today on 22 spt 2005, in how many days the sample analysis shall be completed?

i have seen one company using it as

< 6 month sample analyse in 7 days
6-12 m in 15 days
12-36 m 21 days

do such time windos acceptale to usfda? If there is any referance in literature plese share it.

thanks/ regards

[jitender]

Dont know about guidelines.

I feel one must ensure the storage stability of samples under the condition samples are intended to store for the time period of storage. One may need to optimize the storage conditions. Low temperature as -20 to -80 degree centigrade shall be suitable in most cases (However, suitability must be demonstrated). Else one should analyze sample immediately.

(JUST A GENERAL THOUGHT.)

[DR]

We go with controlled room temperature once a sample has been pulled from a chamber. We try to run them pretty soon after they've been pulled but I know other labs let them sit around for months before they run them. The only real risk you run in doing that is that a sample that would have marginally passed if you had run it within a few days of pulling it would margianlly fail as a result of sitting around for a while. If you toss them in the freexer, you introduce a significant variable.

[Alex Buske]

I don't recognise any guideline about that, but: The longer the samples are stored after pulling from climate storage, the more degradations (or other changes) goe on and your values get worse. Even if that doesn't scratch your specification it would make statistical analysis less reliable.

Alex

[David Blais]

Again, I don't believe there is any official guideline about it. What you have seen in some companies is probably pretty standard. Where I am we do:

0-3 months = Five business days
6-12 months = 10 business days
over 12 months = 15 business days

With samples kept at controlled room temp after pulling from the stability chambers.

[infodas]

hi! Guys!

Every guideiline is silent regarding the analysis time frame.
There are so many 483s for not analysing the sample on time. but in that also the agency didnot suggest the completion time.

my suggestion is .....

The timeline shall be within 7 days for all the samples. If could not perform then store it @ 5-8 deg and complete the analysis within 7 days after the storing period.

Here the assumption is the storage @ 5- 8 deg stops the further degradation.

Finally....

It is better to mention the analysis timframe in ur SOP and follow the same strictly.

Regards

InfoDas