Custom GLP Non-Labeled API Production

Moravek is licensed by the California Department of Public Health, Food and Drug Branch, for the preparation, and 14C or 3H labeling of active pharmaceutical ingredients (API) for clinical trials. In addition, Moravek is allowed to handle schedule I-V classified compounds under DEA authority.
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Moravek is able to perform synthesis, purification, and analysis of non-labeled active pharmaceutical ingredients (APIs) in accordance with good laboratory practices (GLP).

Non-labeled APIs produced or purified under GLP are analyzed on qualified analytical instrumentation and may be supplied with a complete batch record, which includes documentation of the synthetic, purification and analytical processes from start to finish.

After production of the non-labeled API, finished compounds can be sent to a contract research laboratory (CRO), to carry out research.

Production of APIs includes, but is not limited to:

Quality Systems

  • Synthesis, purification and testing in accordance with GLP practices
  • Analytical method transfer (optional)

Production

  • Synthesis carried out in a clean, dedicated fume hood
  • Clean or new glassware for synthesis

Analysis & Documentation

  • Certificate of Analysis certifying non-labeled product was produced in accordance with GLP
  • HPLC, MS, and NMR analysis (as appropriate)
  • TSE/BSE statement (optional)
  • Copy of notebook pages* (incl. reagent sources, lot numbers, and procedures)
    *notebook pages will not include proprietary information
  • Chemical stability data (optional)
  • Utilization of qualified analytical equipment

Logistics & Customer Service

  • Weekly email updates
  • Weekly teleconferences (optional)
  • Initial (kick-off) teleconference
  • Confirmation of storage/packaging conditions
  • Shipping & storage tracking

Shipping & Storage

  • Aliquot preparation
  • Domestic & International door-to-door shipment
  • Secure storage at ambient, +4°C, -20°C, or -80°C
  • Temperature logging during shipment (optional)