Raw materials input into pharmaceutical or medical device manufacturing processes require strict control and consistency of material properties to mitigate unexpected impacts on downstream manufacturing processes. Cambridge Polymer Group serves as an independent third party for raw material characterization and the verification of a manufacturer’s certificate of analysis (CoA).
In the simplest form, raw materials testing may include confirming the accuracy of the values on the CoA. However, we can also assist in determining the most appropriate methods for characterizing the raw material. For example, the method used by a manufacturer for determining purity (e.g. >99% (GC)) may implicitly ignore some critical impurities, such as chemical isomers, water content, and non-volatile species. The “same” material from two vendors may behave very differently despite having the same nominal purity! Our analytical chemists have expertise in evaluating previously reported test results and determining if a nominal material specification may be “blind” to some material characteristics that may impact your process.
CPG may also evaluate additional material properties not captured on the manufacturer’s CoA, and in the context of your product’s ultimate application and end-use environment. This may include:
CPG scientists have experience thoroughly characterizing a wide variety of raw materials, including challenging systems such as naturally derived products or inherently polydisperse materials such as ethoxylated surfactants and other polymeric species.
Contact CPG to see how our raw material characterization and CoA verification capability may fit into your next project.