Reference Standard Materials Program

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

Intertek's 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).

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