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Reference standards

Qualification of pharmaceutical reference standards:
primary and working standards

Experience

Our 30 years of experience in the manufacture, isolation, purification and qualification of pharmaceutical reference standards for quality control make us your trusted partner for reference standards.

In our GMP- and FDA-certified lab, we qualify our reference standards according to the latest scientific and technical knowledge, thereby meeting the current legal and regulatory requirements.

Choose the most suitable standard for your purpose from our portfolio.

 

 

Reference standards

In addition to our regular procut range, we qualify primary standards, working standards or identity and purity standards specifically for you and advise you on further qualification parameters besides identity, content and purity testing depending on the substance characteristics.

Primary standards

Within the scope of qualifying primary standards we also test the identity, content and purity.

Identity testing
Identity testing using spectroscopic methods:

  • 1H-​NMR and 13C-​NMR spectroscopy, recording of coupled spectra as required
  • Mass spectroscopy
  • UV and/or IR spectroscopy

Assay
Assays using two independent methods:

  • Quantitative NMR or titration as an absolute method
  • Chromatographic purity using validated HPLC or GC separation systems including other impurities such as
    • Residual solvents (determination by validated GC separation systems)
    • Water content (Karl Fischer titration)
    • Inorganic impurities

Retesting the primary standards regularly ensures the contents over a defined period.

Dossier
The dossier on the primary standard contains the results of qualification including validation data, an interpretation of the spectroscopic data and an assessment of the specified contents. It can be directly incorporated in CTD modules 3.2.S.5 or 3.2.P.6.

Certificate of analysis
Besides the qualification results, the batch-​specific certificate of analysis also includes details on the shelf life and recommended storage conditions as well as sample spectra and chromatograms.

Working standards

We offer a wide range of working standards for quality control at an excellent price–performance ratio. The content of our working standards is derived from a qualified primary standard using a validated process. The identity is also verified.

Regular retests and pre-portioning in quantities for an analysis period ensure the stability of the working standard.

Please see our product range for the instant availability of our working standards. Other working standards can be supplied upon request.

Besides the qualification results, the batch-specific certificate of analysis also includes details on the shelf life and recommended storage conditions as well as sample spectra and chromatograms.

Identity and purity standards

As part of the qualification of identity and purity standards we test identity and purity. Identity testing using spectroscopic methods:

  • 1H-NMR and 13C-NMR spectroscopy, recording of coupled spectra as required
  • Mass spectroscopy and/or UV and/or IR spectroscopy

Purity testing via chromatographic purity using HPLC or GC separating system.

Besides the qualification results, the batch-specific certificate of analysis also includes details on the recommended storage conditions as well as sample spectra and chromatograms.

Individual reference standard management

We take over your individual reference standard management. Choose exactly what you need!

  • Source or produce your required reference standards
  • Qualification according to the latest state of scientific and technical knowledge
  • Individual portioning for your analysis, under inert gas if required
  • Storage under controlled conditions in line with GMP requirements
  • Monitoring of shelf life and inventory
  • Just-​in-time supply to your laboratory facilities

Your benefits

  • Qualification under GMP according to international regulatory requirements
  • Customised reference-standard concepts
  • Individual portioning for direct use in the lab
  • Handling: good flowability and crystallinity of the reference standards
  • Primary packaging in brown glass vials or brown glass ampoules for light protection, Alu/Alu secondary packaging as protection against external influences
  • Storage under controlled conditions in a GMP environment including shelf-life testing
  • Just-in-time supply to your site under controlled transport conditions, globally in cooperation with Merck
  • Reduction of internal overheads for administration, invoicing, storage, analysis and quality management

Simone Schäfer
Sales Reference Standard

Phone: +49 7272 7767-16
Email:

Kontaktieren Sie uns. Wir helfen Ihnen gerne!

Hotline

Monday - Friday
08:00 - 17:00 o´clock

+49 7272 7767-0