Do you need help designing your forced degradation study?
For an API to meet regulations – RDC 53, ICH Q3A – both a theoretical and experimental degradation profile study are needed, ensuring that the conditions in which an API is susceptible to degradation are well understood. A thorough theoretical assessment is essential to designing a scientifically accurate experimental phase. We can identify the theoretical forced degradation pathways of your API and characterise the structures of experimentally observed degradants.

Have you considered impurity formation in relation to packaging and storage?
Drug product packaging and storage should be selected based on the degradation profile of your API. We can identify possible API degradation pathways to consider, reducing impurity formation resulting from packaging and storage decisions.

Does your formulation pose a risk to your drug product?
API compatibility with excipients and excipient impurities should be scientifically evaluated. We can provide an understanding of formulation compatibility, to support your overall ICH Q3B or RDC 53 assessment.

How are degradation factors impacting the stability of your formulation?
Excipients should be chosen considering API properties to enhance drug stability, in line with the ICH Q3B and RDC 53 guidelines. We can provide an understanding of conditions to consider in your formulation design.

Do you need help developing or reviewing your API impurity profile and specification?
For an API to meet regulations, a theoretical and experimental study are needed to successfully review or develop a complete API impurity specification. We can support your understanding of impurity structures and pathways – resulting from synthesis and degradation – considering starting material, intermediates, by-products, reaction conditions, and your final API.

Do you need support calculating the likely presence of impurities in your final API, ahead of further testing?
As part of a thorough theoretical study, which considers possible impurities at each reaction stage, it is important to calculate associated carry-over risk. We can justify potential impurity purge, to reduce further testing requirements, and support the decision on which potential impurities should be included in your API specification.

Do you need support comparing experimental results to your theoretical impurity profile?
In line with global regulations – including multiple ICH guidelines and Anvisa RDC 964 – it is important to be able to justify experimental results as part of regulatory submission. We can evaluate your experimental results in relation to our in-depth theoretical study, in order to identify observed impurities.

Are potential leachables in your final drug product?
Theoretical knowledge of these extractables is important to identify potential leachables, which may be present in your final drug product. We can provide an assessment of potential leachables, considering your packaging or manufacturing process, in line with current best practice and the upcoming ICH Q3E regulation. Our assessment will guide any further experimental evaluation needed.

We can also conduct a toxicity assessment of any leachable identified, as a non-mutagenic inpurity or potentially mutagenic impurity.