Clinical batch release

Release testing is the testing of a drug substance or product against a predetermined set of specifications. The specification set describes the relevant procedures to be performed as well as the acceptance criteria. 

We perform release testing on all substances that require GMP-compliance. Examples include:

• Drug substance for production of clinical batches
• Drug products used for human administration in clinical studies
• Raw materials used in commercial production
• Marketed products
• Validation batches intended for ICH stability studies

It is of high importance to check independently your  starting material or drug properties before use. Remember: minor deviations at the start can result in major differences in your product final stage and potentially  impact the therapy or patient safety! As an independent and specialized party, Anabiotec delivers you reliable values.
Based on our certificate of analysis, your qualified person releases the batch.
Read more about our release work in the case study 'Can you trust your supplier's certificates?'.

The protocol to be followed is the specification set of the respective drug substance, product or raw material.
Release testing is typically a combination of:

• assay by LC, GC or amperometric and potentiometric titration
• determination of purity (quantification of impurities or related substances)
• chiral purity
• water content determination
• pH measurement
• dissolution testing
• particle size determination
• (near) infra red spectrometry
• UV / Visible spectrometry
• hardness and disintegration
• content uniformity
• other compendial tests as clarity and relative density, degree of opalescence, degree of colouration, loss on drying

Since this is a GMP compliant activity, all methods must be validated or verified (for compendial procedures) prior to use.

Do you want to transfer the release of your product to our laboratory? We advise you how to do this. Is you method not validated yet? We assist you and perform the validation or verification of the related procedures.

Do you need your product to be released urgently? Make contact and ask us about our urgency package.