API, Intermediates, and Excipients
Are you looking for:
- Evidence that the quality of your raw materials, intermediates or excipients is reproducible?
- Scientific proof that your API, intermediates, or excipients have similar physical properties?
- Understanding if some of the properties are critical for final product quality?
Order a package of analyses to characterise a new solid API or an excipient for physical properties such as particle sizes and crystallinity, stability, hygroscopicity etc. Within two weeks, we perform the complete analysis of the compound and write a report that can be used for regulatory purposes.
Organic synthesis intermediates characterisation package.
Choose the set of analysis you need:
- Particle size distribution
- Morphology analysis by optical Microscopy or SEM
- Polymorphic form, crystallinity
- Melting point
- Determination of drying conditions
- Amount of volatiles
Solid-state properties of the raw materials and intermediates of organic synthesis reactions play a significant role in the successful development of a robust organic synthesis and crystallisation process of a drug substance. Particle size distribution and polymorphic form of seeds is a critical quality attribute for the crystallisation process. The properties of the crude crystalline material can affect the robustness of the milling process and the properties of the final ground or micronised material.
Example of a Pharmaceutical product intermediates characterisation package:
- Granules or pellet particle size distribution
- Morphology by optical Microscopy or SEM
- Polymorphism of API and excipients in the granules
- Moisture sorption-desorption behaviour of granules and tabletting mass
- The specific surface area of granules and tabletting mass
- Porosity by nitrogen adsorption-desorption
- Macro-porosity and density variation visualisation by CT scans
- Mercury porosimetry
In-process controls can be essential for QbD studies, risk evaluation process, and root cause investigations.
Elder DP, Kuentz M, Holm R (2016) Pharmaceutical excipients—quality, regulatory and biopharmaceutical considerations. Eur Pharm Sci 87:88-99.
Stahl, P., Sutter, B., Grandeury, A. and Mutz, M. (2018). Alternative Solid Forms: Salts. In Polymorphism in the Pharmaceutical Industry (eds R. Hilfiker and M.v. Raumer). https://doi.org/10.1002/9783527697847.ch2