ICH Topic Q6A requires the determination of the level of extractables and leachables from containers and closure systems. Development and stability data should demonstrate that extractables from container/closure systems are consistently below levels that are acceptable and safe. M-Scan has developed in-house validated methods for the analysis of plasticisers and leachables from rubber seals, tubing and containers as well as analysis methods for other extractables below.
- Plasticisers are analysed by freeze drying and solvent extraction Gas Chromatography-Mass Spectrometry (GC-MS).
- Semi-Volatile Organic Compounds are analysed by solvent extraction GC-MS.
- Detergents. Non ionic and cationic detergents are analysed by positive ion matrix-assisted laser desorption ionisation-time of flight mass spectrometry (MALDI-TOF) or positive ion fast atom bombardment mass spectrometry (FABMS).
- Anionic detergents are analysed by freeze drying followed by negative ion FABMS.
- Oligomeric and Polymeric Species are analysed by freeze drying followed by direct Evolved Gas Analysis-Mass Spectrometry (EGA-MS).
- Residual Solvents are covered by the guideline in ICH Topic Q3C. Buffer salts or other solid material added during manufacture can be analysed for residual solvents by Thermal Desorption GC-MS. (see M-Scan publication ‘Determination of Solvent Residues in Medicinal Products).
- Adsorbed Products adhering to the surface of the container are analysed by a determination of the amino acid concentration on a known area of the empty container.
- TOC is a quick, accurate and inexpensive screening protocol for hydrocarbon contamination and can be used for determining the efficiency of cleaning protocols as required by The Code of Federal Regulations Title 21 CFR 211.6
- All M-Scan services are provided on a fully confidential basis and reports are peer reviewed. When required by the client, studies are conducted in accordance with the GLP/GMP Compliance Programmes.
M-Scan Brochure: Biotechnology and Pharmaceutical Analysis (8pp.)