About CTI: Company Profile; Sustainability; Media Center; Contact Us

Our Services: Our Services; By Industry; Specialty

Investor Relations: Stock Information; Management; Information Disclosure; Communications

Resource Center: Application Forms; Bulletin; Training Center; CTI Academy

Reports Validation

Join Us: Talents Policy; Recruitment

AUTHORITY & TRUST
QUALITY & VALUE

Home > Our Services > Pharma and Medical Services > New Drug Preclinical Research > Service Details

Extractables and Leachables (E&L) Studies

Compatibility studies include the analysis of extractables under controlled, tightened laboratory conditions and the analysis of leachables under actual conditions of use. In recent years, as the laws and guidelines of domestic and foreign regulatory agencies have become more and more perfect, the compatibility study between drug products and packaging systems of high-risk preparations, such as injections, oral-nasal inhalers and other dosage forms, has become a key direction of regulatory attention. The rapid advancement of biopharmaceuticals in China has made the compatibility study of disposable systems/components imminent. CTI Sinotest provides compatibility studies of pharmaceutical packaging materials, compatibility studies of biopharmaceutical disposable systems (SUS) and material characterization services for medical devices.

Consulting quotation

Extractables and Leachables (E&L) Studies

Single-use system (SUS)

Extractable and/or leachate studies are provided for manufacturers of disposable systems and manufacturers of biopharmaceuticals in accordance with the BPOG Standardized Extraction Scheme (2020 Edition) and USP <665> and <1665>. Common study objects for disposable systems include: silicone tubing, reservoir bags, stirring bags, filters, etc. In addition, disposable system chemical compatibility, adsorption, and bacterial retention studies and integrity testing are also available.

Pharmaceutical Packaging System Compatibility Studies

The study protocols are formulated with reference to PQRI extraction protocols, and at the same time meet the requirements of USP2021<1663> and <1664>; the study process meets the requirements of data integrity; the study report can be used for reporting to the FDA and the EMA, etc.; at the same time, we can customize the study protocols for the domestic reporting of the customers. Pharmaceutical packaging systems include: vial and stopper combinations, pre-filled syringes, glass ampoules, and so on.

Medical Devices

Material characterization of medical devices is carried out in accordance with the guidelines of ISO 10993-18:2020 edition; and the results are evaluated in accordance with ISO 10993-17:2002 edition.
Medical devices with different contact times with the human body have different requirements for safety assessment. For medical devices that come into contact with the human body over a long period of time, such as orthopaedic implants and cardiac implantable devices, a comprehensive characterization of the materials used is required to assess the safety during the life cycle of use.

Equipment Advantages

Use HS-GC-FID/MS to analyze volatile organic compounds; GC-FID/MS to analyze semi-volatile organic compounds; LC-DAD/MS to analyze non-volatile organic compounds; ICP-MS to analyze ppb level elements with high safety requirements; ICP-OES to analyze common ppm level elements. We use Thermo LC-QE to analyze the structure of unknown substances.

Professional Team

We have rich experience in the study of extractables of common materials. For most extracts, we can provide compound information quickly; for a few unknowns, we use QE to perform structural analysis to minimize unknown compounds. Provide favorable guarantee for safety assessment.