Pharmaceuticals & Veterinary Medicine
Active ingredients and small molecule technical and analytical support
Small molecule technical and analytical support for the Pharmaceutical and Veterinary Medicine Industries
Quality, efficacy and success of drug development and manufacturing are strongly reliant on the integrity and performance of your active pharmaceutical ingredients (APIs). CEMAS can provide comprehensive technical and analytical support to ensure that your small molecules, APIs and raw materials meet the highest standards of quality, safety, and effectiveness, at any stage of the life cycle of your product.
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Method Development and Validation
Explore how we can develop and validate analytical methods that are robust, accurate, and compliant with regulatory standards. We employ a wide array of techniques, including chromatography (HPLC, UPLC, GC), spectroscopy (UV, IR) and mass spectrometry, to meet the specific needs of your API and small molecule analysis. Our methods are designed to ensure precision, reproducibility, and suitability for routine use in both R&D and quality control environments.
Find out more about Method development and validation
API and Small Molecule Characterisation
Explore how CEMAS can provide comprehensive characterisation and assessment services to help understand the behaviour of your API and small molecules in your various formulations. We will help you navigate the complexities of raw material sourcing, mitigate risks, quality control, ensure compliance with regulatory requirements and enhance the overall quality of your products.
Find out about our Characterisation services
Shelf-life and Stability
CEMAS designs and conducts stability studies under ICH-recommended conditions to assess the degradation, shelf life, and recommended storage conditions of your APIs. Our data-driven approach provides you with reliable information to make informed decisions about your product’s lifecycle.
Find out more about Storage stability
Contamination and Impurity Assessment
We provide thorough impurity profiling services, including identification, and quantification. Our analytical techniques enable us to detect and characterise even trace levels of impurities, ensuring your product’s safety profile is uncompromised
Find out more about Impurities
| Category | Analytical Solutions Offered |
|---|---|
| Method Development | Analytical Method Development Stability-Indicating Method Development Impurity profiling |
| Regulatory Compliance | Validation of Analytical Methods (ICH/VICH Guidelines) Batch Release Testing Regulatory Submission Support |
| Advanced Characterisation | Structural Elucidation Chromatographic Techniques Spectroscopic Analysis |
| Stability Studies | Stability Testing Forced Degradation Studies Shelf-Life Determination |
| Quality Control | Assay Testing Content Uniformity Dissolution Testing Residual Solvent Analysis |
