SErvices

Reference Materials

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

We are recognised as a leading innovator and reliable provider of reference standards to pharmaceutical and agrochemical companies around the world to support drug manufacturing and fine agrochemical manufacturing. 

 

We are world leaders in phenylephrine chemistry and provide reference materials to support the safe manufacture of Active Pharmaceutical Ingredients worldwide.

 

Our standards 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 products can be easily validated against the relevant pharmacopoeial primary reference material and used as a secondary standard. In many cases for degradants and impurities for which there is no pharmacopoeial standard our products are the primary reference standard. 

 

We make standards for impurities, degradants and metabolites of active pharmaceutical ingredients, finished drug products and excipients.

 

Our Australian facility is ISO17025 and ISO17034 accredited and 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 for overall purity.

 

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

 

We also stock and supply ‘difficult to find’ degradant standards and non-compendial standards, including a range of rare standards 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

We work closely with a number of global pharmaceutical manufacturers and are expertly placed to:

  • Identify new or unknown impurities and degradants.
  • Synthesise authentic samples.
  • Prepare and supply new working standards to ISO 17025 and ISO 17034 quality.
  • Provide expert advice on degradant and impurity formation. 

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.