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EXTRACTABLES AND LEACHABLES ANALYSIS

According to the FDA, "a container closure system refers to the sum of packaging components that together contain and protect the dosage form." This includes both the primary components which come in direct contact with the drug product, and secondary components such as labeling and outer cartons. Any compounds that can leach into the drug product from the container closure system (CCS) can pose a risk to the patient. Similarly, CCS components (both primary and secondary) must be qualified to be non-toxic by analyzing compounds which can be extracted in the presence of a solvent, if this information is unavailable.

Understandably, the long-term use of parenteral and inhaled dosage forms by patients coupled with a lack of knowledge of material sources in the CCS on the part of drug manufacturers necessitates the analysis of extractables and leachables from the CCS. This risk-based approach is useful in preventing any potential adverse reactions in the patient population that can be attributed to the CCS materials and their interactions with the drug product. Testing methods are explained in the USP monographs <661>, <1151> and <601>.

The analytical team at Pacific BioLabs can help you to develop a testing program most suitable to your CCS and drug product based on these compendial references. Analytical chemists can measure leachables and extractables by GC, GC/MS, and ICP-MS, and characterize and elucidate the structure of compounds by HPLC and mass spectrometry. They will work directly with you to design the most appropriate extraction conditions after considering parameters such as time, temperature and choice of solvent.

Available Services

  • HPLC
  • GC
  • GC/MS
  • LC/MS/MS
  • ICP-MS
  • UV-Vis

FDA Guidance Documents

Container Closure Systems for Packaging Human Drugs and Biologics. May 1999.

Container Closure Systems for Packaging Human Drugs and Biologics. Questions and Answers. May 2002.

 
 
 
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