Custom Synthesis of Reference Standards

EPP’s founder Dr. Stephen Newlands created the company on the basis of high quality synthetic organic chemistry. This founding feature remains true today and we have being providing custom synthesis of analytical reference standards for nearly 25 years. Our knowledge ranges across several sectors:

Ann EPP chemist in the synthesis laboratory

  • Agrochemical reference standards
  • Pharmaceutical reference standards
  • Controlled drug reference standards

EPP’s synthetic lab supports our 5-batch analysis service, providing active and impurity standards, as well as degradants. This reduces delays in outsourcing. We also support other CROs and large manufacturing companies, providing high purity reference standards for use in their in-house QC testing.

Over 85% of our synthetic chemists have PhDs and we have a wealth of experience in difficult to synthesise compounds.

Our strengths lie in the custom synthesis of:

  • active reference standards
  • impurity reference standards
  • metabolite reference standards
  • degradation reference standards

We have experience of synthesising compounds related to over 200 actives, often those which are often closely related in terms of chemical structure.

All of our analytical reference standards are produced with a certificate of analysis typically including:

1. PHYSICAL DATAAppearance

Melting point

2. IDENTITY DATA

 

Proton NMR spectrum, 500MHz

Carbon NMR spectrum, 125.8MHz

FT-Infrared spectrum

LC-MS

3. PURITY DATAHPLC-UV

Water content

Residual solvent by 1H NMR

Loss on drying

The above certificate of analysis data can also be produced to GLP should it be required.

 

NMR certified reference standards

EPP offers qNMR certified reference standards should your compound be difficult to certify by UV.

Custom synthesis of stable isotopically labelled compounds, GLP or non-GLP

At EPP we have huge experience across an array of stable isotopes and have the capability to synthesise ¹³C, ²H, ¹⁸O and ¹⁵N isotopically labelled compounds.

Stable isotopically labelled reference standards, such as internal standards are often required for the accurate quantification of low levels of active ingredients, related impurities or metabolites. At EPP, we have many years experience of the design & synthesis and certification of internal standards, used for method validation and Quality Control purposes including GLP studies utilising MS quantification approaches.