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- Posts: 108
- Joined: Fri Sep 03, 2004 3:42 pm
- Location: South Africa
We need to perform a method validation on an Assay for a drug product. The formulation is relatively straight forward.
The drug substance is dissolved in water and then pH adjusted to 4.5 - 5.5 with 0.1M Hcl. Once pH adjusted, the solution is made up to volume. Currently, drug product is not available for us to perform the method validation.
Since this is a simple formulation, would we be able to make a lab scale batch and use this to validate the Assay method?
Regards
Michael