Our service

Centre Testing International Co., Ltd. (CTI) is the pioneer and leader in the TIC Industry which provides one-stop solutions on testing, inspection, certification, calibration, audit, training & technical services.

 

By Industry

Our service capabilties cover the upstream and downstream of the supply chain including textile and apparel,toys,electronic appliances,medical health,food...andother industries.

Specialty

Comprehensively guarantee quality and safety, promote compliance and innovation, demonstrate brand competitiveness, and achieve higher quality, healthier, safer, and greener sustainable development.

Extractables and Leachables (E&L) Studies

2024-11-04 323

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.