Hello!
As a part of cleaning validation master plan, I am trying to develop a method to determine the solubility of the final drug product in various solvents. Can anyone help me out with the parameters that should be included while determining the solubility? What’s the best laboratory method for solubility determination?
Check Merck Index for solubility. Then dissolve ~1 mg in 10 mL of these common RP solvents (water, methanol, IPA, acetonitrile…), and note dissolution of drug. Select the best as your recovery solvent. Do not use Class I and II USP <467> solvents (particularly on your manufacturing process train).
The usual practice is to spike a known amount of the drug onto a steel or glass plate then swab the plate according to your cleaning SOP. Then extract the drug and measure the extracted concentration, and determine recovery.
Dr David Trew
BSc (Hons), PhD, CChem MRSC
Director
David Trew Consulting Ltd
Consultancy services for chemistry based businesses
and laboratory service sectors.
davidtrew@davidtrew.co.uk
Telephone: +44 (0)1494 700693
The information provided in this post is for information purposes only and does note constitute consultancy. Therefore no liability is accepted for any reliance on this information.