Fitness for Purpose Statement
Method should be able to quantitatively analyze withanolide glycosides,
W h f
A d l
h d f
l
h
d
it a erin- an o igosacc ari es rom nutraceutica matrices, suc as pow ers,
tablets, capsules and liquids.
Method is confirmatory and will be used to pass or fail a batch of the raw
material (powder extract) or a finished product, such as a tablet or a capsule.
There is no regulatory requirement
The method will be used in a laboratory set up.
Chemists trained in HPLC/HPTLC techniques will be required to do the analysis.
3
Fitness for Purpose Statement
Points for discussion by SPDS
How does this method address Ashwagandha extracts made by different
manufacturers
What should be the targeted analytes
Limits of quantification
Availability of reference standards
4
