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Reference Standards

About Reference Standards

Reference standards are used in the global pharmaceutical, biotechnology, Clinical and bio-analytical CRO industries.

Sussex-Research synthesizes reference standards which are routinely used for quantitation and qualification of API (Active Pharmaceutical Ingredient), Metabolites and NCE’s (New Chemical Entity), as well as for Internal Standards in bioanalytical methods. The reference standards we synthesize include:

  • Stable isotopes ( Deutrated , 13C and 15N)
  • Glucuronides
  • Metabolites
  • Impurities

Stable Isotope reference standards are used as internal standards in bioanalytical LC-MS/MS methods. The inclusion of stable isotope internal standards reduces method development time and results in more accurate, precise and rugged bioanalytical methods. The use of Stable Isotope internal standards in these methods greatly enhances the quality of the data which is favorable for FDA submission.

The potential advantages of deuterated pharmaceuticals:

  • Improve metabolic profile: The improve metabolic profile may potentially reduce or eliminate unwanted side effects or undesirable drug interaction
  • Improved oral bioavailability: Deuteration in some compounds has reduced the presystemic metabolism that occurs in the digestive track allowing more of the drug to reach its target.
  • Increased half-life: Deuterated compounds can have slower pharmacokinetic affect extending the absorption and distribution in the body. This may decrease the number of doses patient may require in certain period.

Glucuronides and Metabolites are used qualitatively to demonstrate identity, strength, purity and quality, and quantitatively to determine concentration for medicine, dietary supplements, and food ingredients.

Impurities are used to provide confirmation of identity and concentration of process-related impurities in the manufacture of API’s and NCE’s