Reliable, Sensitive & Accurate methods
to identify and analyze any excipient
First-class Pharmaceutical Excipients Testing & Analysis
We offer a series of modern techniques to help you overcome excipient analysis hurdles
Our Innovative Excipient Analysis Offers Various Benefits:
Reduce the time, Cost & Labor
involved in the analysis process
Help to Introduce Products to Market
that conform to regulations and standards
Fully Dedicated to the Physical Characterization of Excipients
We support GC-MS, LC-MS/MS, NMR, ICP-AES, and ICP-MS testing techniques. Our comprehensive structural characterization of excipients including particle size, shape, surface area, and particle arrangement in the lattice helps you understand the functionally relevant properties (FRC) of your excipients.
Composition ldentification and Quantitative Analysis of Excipient
The composition, quantity and concentration levels of excipients are critical to the pharmacokinetics and stability of your drug. Chemical characterization by various coupling techniques to determine the identity, purity and quality of excipients to ensure the safety and efficacy of drug formulations.
Accurate excipient-API compatibility testing
Excipients may interact with APls, thereby altering absorption, distribution, metabolism and excretion (ADME) and ultimately reducing APIs bioavailability. Physical and chemical interactions between excipients and APIs are studied to assess the compatibility of excipients with the active ingredients in the drug.
Impurity ldentification & Analysis
Impurities or contaminants in excipients can affect the synthetic manufacturing phase of APIs, and the final stability and shelf life of the product. Therefore, analysis and elimination of potential process-related impurities through mass spectrometry, spectroscopy and chromatography are critical in the development of drug products.
Novel Quality Control Strategies for Excipients
To avoid any risk of chemical interactions or even toxic reactions, excipients are subject to strict regulatory restrictions. We determine the development and validation of variability and stability analysis methods for excipients according to relevant standards (ICH, USP, EP, I/SO) to achieve a safe, robust and stable product delivery.
