Generating Reference Standards

[vishall79]

Hi,
Can anyone plese tell me what tests need to be performed on liquid sample to declare it as reference standard?
Is there any guideline in USP or WHO for the same?

[tlahren]

Here in the US we had to analyze it multiple times and show that it compared well to a NIST (National Institute of Standards and Technology) certified standard. Usually this was done when using a previously certified standard that had expired. ASTM (American Society for Testing and Materials) had a similar approach for creating Iron Ore standards from bulk mixes. I can't remember exactly but it had to be analyzed something like 25 times over a broad time course and compared to a NIST or other certified standard along with it.

The other option is to see if you could send out your standards and have them certified by a similar agency in India?

[krickos]

Hi

Also ICH Q7a in §11 (i think), has some basic requirements if your in the pharma buisness. A bit unsure what you trying to do, is more like a stock/calibration solution (and investigate stability?!) made from a primary/secondary/NIST traceble etc reference standard?
If thats the case I would do comparison (stability of solution) between stored solution and freshly prepared standard over the desired amount of days of intrest.

[Blazer]

As Krickos points out (thanks again for your help in my thread, Krickos), ICH Q7 sections 11.17 - 11.19 has information regarding reference standards. I suggest downloading a copy of this document and reviewing it. It's probably a bit more vague than you want (i.e. it won't tell you what tests to run) but it's a good source document for your toolbox.