Reference Standard Programs

Comprehensive reference standard services are available from Intertek Pharmaceutical Services, including initial characterization, expiry dating, and re-certification, as well as storage and distribution. These services can be applied to Reference materials 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.

Complete Characterisation:

• Identification  (CHNS, IR, UV/Vis, 2-D and 3-D NMR(H1& C13), MS)

• Physical  (Melting/Boiling Point, Optical Rotation, TGA, pH)

• Purity  (HPLC, LC-MS, GC, GC-MS, Residual Solvents, Titration, KF, Metals Screen, ROI, DSC, chiral or diasterometic purity, impurity profile)

Complete RSM Program for corporate RSMs:

• Initial Characterization

• Generation of a Certificate of Analysis

• Expiry Dating through stability testing

• Repository & Distributor

• Periodic Re-qualification

• Complete Characterization of Sample Limited RSM

Applications:

• Compendial RSM

• Non compendial RSM

• Sample limited RSM (impurities, metabolites, or other expensive materials)

• Biologic macromolecules such as oligonucleotides, recombinant proteins, vaccines, antibody therapeutics

• Polymeric and oligomeric species

• Pharmaceutical analysis