Physical and Analytical Chemistry Expertise
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The Search for Optimal Solid Form Properties: Our Services and Approach for Pharmaceutical and Fine Chemical Development and Crystallization Different crystalline solid forms of an active pharmaceutical ingredient (API) can have very different physico chemical properties. Those differences can... Read more »
Triclinic Labs offers a comprehensive suite of services for the analysis of particle characteristics. In either a cGMP and non-GMP environment, we can fully characterize your preparation and develop methods for agency submission, routine testing, pre-clinical development, and markets release.... Read more »
Whether, you require simple analytical services for materials identification, more extensive interpretation of analytical data, or development of analytical methods, we have the experience and techniques to meet your needs. Pharmaceutical (Drug Substance, Drug Product, Excipients, Raw... Read more »
By Triclinic Labs, Inc
This application note outlines the evaluation of post-dissolution ACE SDD. The results indicated that in all of the cases studied, ACE remained amorphous upon dissolution if it was intimately mixed in the dispersion. However, phase separation from the polymer allowed ACE to crystallize as...
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By Triclinic Labs, Inc
What is the impact of recent changes in FDA guidance on regulatory and intellectual property issues?
The FDA reclassification of cocrystals as active pharmaceutical ingredients (APIs) has created exciting opportunities for the pharmaceutical industry. That reclassification means cocrystals can...
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By Triclinic Labs, Inc
Amorphous solid dispersions (ASD) have long been used to increase the solubility and bio-availability of poorly-soluble compounds. A considerable amount of research has been car-ried out and has generated useful techniques in the area of ASD development. Surprisingly, the number of examples with...
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Posted 6/10/2024