Information collection and preliminary risk assessment: carry out scientific risk assessment according to the information of drug packaging materials, packaging specifications, physical and chemical properties, route of administration and daily large dosage provided by customers, and customize project specific research schemes for customers.

It covers the extraction research of ionic strength, pH, polarity, etc., so as to obtain sufficient and complete extractable materials and help customers screen better direct packaging materials.

Combined with the actual production and development process of customers, simulation experiments under extreme conditions are designed to simulate the extractable situation of actual drugs and packaging systems under poor conditions, so as to provide a scientific basis for the selection of migration research detection items and methods.

According to the Chinese Pharmacopoeia, USP and other relevant regulations, the life cycle management of the test method is carried out. The methodological validation items include but are not limited to specificity, accuracy, precision (repeatability, intermediate precision), detection limit and quantitative limit.

Safety evaluation: refer to the toxicological data provided by TOXNET, FDA, ICH, EMA, etc., and calculate the analysis and evaluation threshold (AET) according to PDE and SCT, so as to evaluate the safety of extractables and leachables content results.

Research evidence: YBB 00142002-2015 Drug Packaging Materials and Pharmaceutical Compatibility Test Guidelines, Technical Guidelines on Compatibility Research between Chemical Drug Injection and Plastic Packaging Material (Trial), Technical Guidelines on Compatibility Research between Chemical Drug Injection and Pharmaceutical Glass Packaging Container(Trial), Technical Guidelines on Compatibility Research between Chemical Drugs and Elastomeric Sealants (Draft for Comments), USP<1663>, USP<1665>, USP<665>, and ICH Guidelines, etc.