5 WAYS CHEMICAL CHARACTERIZATION IMPROVES PHARMA DEVELOPMENT
Chemical characterization is a complex process involving the identification of unknowns in organic and inorganic materials. This is an invaluable service for pharmaceutical and drug development organizations looking to improve their product by discovering and removing unwanted materials, experimenting in adding materials, or investigating competitive products.
The veteran chemists at Avomeen Analytical Services have developed expert methods to master the science behind materials ID and chemical characterization. Avomeen’s FDA-registered, DEA-licensed, and cGMP compliant laboratory is equipped with advanced instrumentation including GC, GC/MS, LC/MS, NMR, SEM, EDXA, HPLC, and FT-IR, which are used to separate, identify, and quantify the components of a sample.
Applications to Chemical and Pharmaceutical businesses include:
1. Impurity Identification and Quantitation
Avomeen chemists carefully examine a sample and isolate complex trace impurities in APIs and excipients including contaminants, degradants, and process impurities. This information is critical for regulatory filings as well as creating methods for improved process control.
2. Batch-to-Batch Testing
With this testing, scientists closely monitor a product’s properties for each batch, to ensure all release specifications are met. During process development, continued monitoring of batch composition for a wider range of properties will allow the manufacturer to develop the most effective release specification for the product.
3. Trace Metals/Residual Solvents Analysis
As trace metals and residual solvents may be hazardous to human health or the environment, Avomeen offers analyses to determine levels of trace metals and residual solvents for both the pharmaceutical industry as well as the chemical and consumer products industry to allow manufacturers to comply with a broad range of regulations including ICH and FDA guidance’s, CONEG, WEEE, ROHs, as well as CPSIA requirements.
4. Extractables/Leachables Testing
This testing studies the organic or inorganic compounds that may be released from a product, or absorbed into a product from defects in the manufacturing or packaging process. Avomeen will work with clients to develop a customized testing protocol to meet your regulatory requirements, whether your need is for a package or medical device registration, a label migration study, packaging for food contact, or simply consumer product testing for Bisphenol A (BPA) and Phthalates (such as DEHP).
5. Competitive Analysis & Patent Infringement Investigations
This service consists of a thorough exploration of the chemical make-up of a competitor’s product. This produces a highly detailed analysis which can be used in a number of ways, from discovering the secret ingredients of a competitor, to inspecting a possible patent infringement. In the case of infringement, Avomeen offers professional litigation support such as expert witness testimony.
By utilizing Avomeen’s chemical characterization services, product developers are given the power to create and improve a product’s efficacy. From examining contaminants to investigating competitors, Avomeen offers customized, quality-driven services that expedite the time between product creation, development, and release.