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Custom Synthesis of Pharmaceutical Impurity Reference Standards
FB Pharmtech are highly experienced in the custom synthesis of pharmaceutical impurity reference standards for use in the development of new pharmaceutical products.
Pharmaceutical drug development is a stringent process that any company developing a new pharmaceutical product must adhere to. A key aspect of the development process is identifying and quantifying all the components present in an Active Pharmaceutical Ingredient (API), including all the impurities that are present above a certain level.
Impurities produced during the API manufacturing process can influence the safety and efficacy of the final product, and for this reason, there are strict controls placed on the allowed levels of impurities present in the completed API.
Allowed impurity levels for a specific API are set out in drug monographs which are established by national pharmacopoeias, e.g. British Pharmacopoeia (BP), European Pharmacopoeia (EP), United States Pharmacopoeia (USP), etc. Monographs also set out the analytical methods which must be used when analysing an API.
To accurately quantify the content of a structurally unique impurity present in an API, a reference standard of the same impurity must be used when carrying out the analysis to establish purity/content levels. Each impurity must be made by synthesis and analytically certified to confirm the structure and purity of the impurity reference standard.
FB Pharmtech’s Impurity Custom Synthesis
FB Pharmtech are highly experienced in the synthesis of certified pharmaceutical reference standards for use in pharmaceutical development and analysis. We have experience in making impurities on mg-100g scale, including structurally complex molecules with several synthesis steps that require challenging purification. We can also synthesise materials requiring preparative-HPLC separation and chiral separation.
All of our custom synthesised impurity reference standard comes with a detailed certificate of analysis which utilises several different analytical techniques to confirm structure and accurately confirm the purity, including the presence of inorganic material, moisture and volatile residual impurities. We use a combination of H NMR, HPLC, MS, CHN analysis, Karl Fischer titration, residual solvent analysis, elemental (CHN) analysis, inorganic content, melting point and TGA analysis, according to our customer’s specific requirements.
Amongst our customers are internationally renowned impurity reference standard catalogue companies and national pharmacopeial organisations, both of which we supply bulk impurities to, and some of our impurity standards are used to help establish monographs for APIs.
Work with FB Pharmtech?
For pharma companies requiring a regular supply of a specific impurity (or impurities), FB Pharmtech are able to offer a consignment (store and supply) service where we synthesise a bulk amount of an impurity, then store this and deliver aliquots of the required material(s) as needed with an updated COA. This can help our customers save money instead of making repeated purchases of the same impurity from a commercial supplier.
Please contact us if you would like to receive a custom synthesis quote for any impurity you require.