Pharmaceutical Reference Materials

PHARMACEUTICAL REFERENCE MATERIALS

Our extensive range of high-purity reference materials sets us apart.

We are recognised as a leading innovator and reliable provider of reference materials to pharmaceutical and agrochemical companies around the world. We make reference materials for impurities, degradants and metabolites of active pharmaceutical ingredients, finished drug products and excipients.

We are world leaders in phenylephrine chemistry which supports the safe manufacture of Active Pharmaceutical Ingredients worldwide.

Our reference materials are prepared to maximum possible purity and where a pharmacopoeial standard exists, are supplied as bulk, fully characterised working standards equivalent to BP / EP and USP grades.

Our Australian reference materials are supplied with a comprehensive data package that includes all of the relevant analytical data, spectra and conditions to establish identity and purity.

We routinely characterise our products with 1H NMR, LC/MS, CHN elemental analysis and IR for identity. We establish purity with HPLC, Karl-Fischer water content, ash content and residual solvent content. In specific cases we also use X-ray crystallography to determine relative stereochemistry, chiral HPLC for enantiomeric purity and, where required, Quantitative 1H NMR.

See here for an example of the Product Information Sheet we provide with our reference materials.

We also stock and supply ‘difficult to find’ degradant and non-compendial reference materials unique to Epichem as a result of our long term and deep understanding of the chemistry and behaviour of some well-known active pharmaceutical ingredients.

Stocks of all our catalogue products are maintained at all times to ensure dispatch as required.  Our products are shipped world-wide with full documentation to ensure expeditious customs clearance.