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Service

Quality Research Service

service content

API(Active pharmaceutical ingredients) quality research service:
◊ measuring the solubility and pH- saturated solubility curves of API in various media；
◊ Effect of particle size of API on dissolution in vitro；
◊ improving API quality standards.

Auxiliary material quality research service：
◊ improving auxiliary material quality standards

Develop and validate analysis method services：
◊ Preliminary establishment and verification of content methods；
◊ Preliminary establishment and verification of material methods；
◊ Preliminary establishment and verification of dissolution methods.

Stability inspection service：
◊ investigating the effect of different packaging materials on product quality；

◊ Scheme design for stability study providing, Stability sample retention and testing, Data trend analysis, Drug shelf life assessment；

◊ Influencing factors, acceleration and long – term testing.

Research on the compatibility of packaging material
◊ The compatibility research scheme of drug packaging system design such as ampoules, syringes and rubber plugs, assisting to declare drugs.
◊ Using the semi-quantitative scanning method to extract the additives from pharmaceutical packaging materials, including antioxidant, plasticizer, vulcanization agent, lubricant and so on.
◊ Use specific detection of element impurities for different drug delivery routes.

Verification study on packing tightness
◊ Test and verify the integrity of closed containers；
◊ Check the seal integrity of the entire package or container.

advantage

◊ Successfully developed and completed the preparation study of nearly 50 varieties, some projects have passed the NMPA field inspection for many times.
◊ The r & d team has more than 3 years average of industry experience.
◊ With nearly 100 sets of quality analysis equipment.
◊ Verify the capability of detection, obtained the certificate of ability verification issued by China national inspection institute.
◊ The laboratory and quality shall be operated and managed according to the relevant standards of China National Accreditation Service for Conformity Assessment (CNAS).

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