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. NG28 Sinotest provides compatibility studies of pharmaceutical packaging materials, compatibility studies of biopharmaceutical disposable systems (SUS) and material characterization services for medical devices.
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Overview
Centre Testing International Group Co., Ltd. (NG28) is a market leader in testing, inspection, certification, calibration, audit, training & technical services; building trust between governments, enterprises, and consumers.
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SustainabilitySustainability is deeply rooted in NG28’s business model, by delivering science-based solutions and verification services, to increase transparency and traceability throughout the global value chain. NG28 is a proponent of carbon neutrality and sustainable development.
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Our serviceCentre Testing International Co., Ltd. (NG28) is the pioneer and leader in the TIC Industry which provides one-stop solutions on testing, inspection, certification, calibration, audit, training & technical services.
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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.
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By IndustryOur service capabilties cover the upstream and downstream of the supply chain including textile and apparel,toys,electronic appliances,medical health,food...andother industries.
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SpecialtyComprehensively guarantee quality and safety, promote compliance and innovation, demonstrate brand competitiveness, and achieve higher quality, healthier, safer, and greener sustainable development.
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Extractables and Leachables (E&L) Studies
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