Intertek (www.intertek.com)
 

Reference Standard Materials Program

Industries serviced: Medical & Pharmaceutical

E-mail Us

Call Us

EMEA UK:+44 161 721 5247
USA:+1-908-534-4445 x669

Intertek ASG

P.O. Box 42
Hexagon Tower
Blackley
Manchester, M9 8ZS
United Kingdom

Intertek QTI

P.O. Box 470
291 Route 22 East
Salem Industrial Park
Whitehouse, NJ 08888
USA

Reference standard materials program services, include initial characterization, expiry dating, re-certification, plus storage and distribution.

Intertek Reference Standards Materials program services can be applied to reference standards used for assay, degradation product quantification, process impurity identification and quantification. Applications also include sample limited Reference Standard Materials (RSMs) such as biologics or similar complex and expensive materials. RSM programs can be offered for primary, secondary, compendial and non-compendial reference standards.  Impurities (organic and inorganic) and residual solvents can be identified and quantified.

The complete Reference Standard Materials (RSM) program is designed for impurities, metabolites, or other expensive materials.

Reference Standard Materials Services:

  • Initial characterization
  • Generation of a certificate of analysis
  • Expiry dating through stability testing
  • Repository and distributor
  • Periodic re-qualification
  • Complete characterization of sample limited reference standard materials (typically requires 100-200 mgs material)
  • Methods for complete characterization typically require 1-2 grams of material

Applications include non-compendial RSM, sample limited RSM and biologic macromolecules (oligonucleotides, recombinant proteins, vaccines, antibody therapeutics, polymeric and oligomeric species).

Related Reference Standard Materials Program Services:

to see how Intertek can help your organization with Reference Standard Materials Program.

© Intertek Group plc. Disclaimer
Home Services What We Do Contact Us