Reference Standards Management Service

At EPP we know there are a number of common problems associated with analytical reference standards which can hinder your QC testing. From not being commercially available through to degradation, these uncertainties can be costly and time consuming.

To save time and administration costs across the lifetime of a longer project, we can prepare larger quantities of reference standards at the start of the project and store these, supplying the exact quantity in the defined pack sizes as requested by the client.

 

How this service works

We scope your requirements to provide a bespoke contract for the administration and supply of certified analytical reference standards to you. This includes the form, purity, pack size, quantity and delivery dates to meet the technical requirements of your analytical work programmes.

 

 
• We agree the period of the designated analytical work programme with you e.g. a five year manufacturing cycle or three year stability study

• We advise the shelf life of custom synthesised analytical reference standards that we produce

• We provide the exact quantity of an analytical reference standard to you on pre-arranged dates and will organise any re-certifications during the timeframe of the analytical work programme

• We accept full responsibility for any possible re-synthesis or purification of the stock material held at EPP prior to dispatch to you in fulfillment of the contract. This benefit is included in the Reference Standard Management Service fee

 

The categories of certified analytical reference standards that we provide include:

 

  • standards for QC Testing Relating to Process Development and Routine Manufacture of Advanced Intermediates and APIs
    • Impurities in active ingredients
    • Isolated intermediates (and impurities in such intermediates)
    • Non-isolated intermediates (e.g. those which require to be quantified via in-process checks)
    • Raw materials (and impurities in raw materials)
    • Internal Reference Standards
  • standards for API and Formulation Stability Testing Work
    • Impurities in active ingredients
    • Storage impurities / degradants
    • Forced degradation impurities /degradants
    • Internal Reference Standards
  • standards for Pre-clinical Drug Development Work
    • Metabolites
    • Stable-labelled variants of active ingredients and metabolites (e.g. 2H or 13C variants)

Certificates of Analysis

Each analytical reference standard prepared at EPP is supplied with a comprehensive Certificate of Analysis detailing physical data (appearance, melting point), identity data (1H NMR, 13C NMR, IR and MS), and purity data (HPLC-UV / GC-FID / NMR, loss on drying, residual solvent). In addition to the standard analysis we may include other tests depending upon the nature of the compound and client requirements, such as sulphated ash, optical rotation, CHN analysis etc.