SPDS SET 2: ASH-01

7.0] REVALIDATION CRITERIA: The above HPLC method need to be revalidated if the

1) Sample matrix is different (for example Withania somnifera extract is mixed with other

botanical extracts or excipients). 2) If there is any change in the column packing material other than C18 or the dimension of the column or the particle size are very different from the one used for the validation (example instead of column with dimension 250mm x 4.6mm, a column 5 mm x 4 or 15 x 2.0 mm are used). 3) An instrument with different characteristic is introduced like change in the detector

(example instead of a UV detector an ELSD etc.)

4) If sample solution results or QC sample analysis are out of specification and the source of

error cannot be tracked back. However, it needs to be identified.

The extent of revalidation and the method characteristic selected solely depends on need and lead to the choice of the in-charge.

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3DJH RI