T/CNPPA 3007-2020 Active Group standards

T/CNPPA 3007-2020 Inhalation aerosol packaging system extraction research guideline

Publish Date: 2020-03-16 Implement Date: 2020-03-16 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CNPPA 3007-2020

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Logo, packaging, transportation, storage

ICS Name: Comprehensive Pharmaceutical Science

Publish Date: 2020-03-16

Implement Date: 2020-03-16

Scope

Main technical content: Inhaled aerosols, due to the fact that their drug formulations mainly consist of organic solvents, and their packaging systems are structurally complex, involving a variety of materials such as plastics, rubber, and metals, the compatibility study between their packaging systems and drugs has always been a key focus and challenge for the pharmaceutical industry at home and abroad. The extraction study of packaging systems is an integral part of the compatibility study between inhaled aerosols and their packaging systems. This standard provides guidance for the extraction study of inhaled aerosol packaging systems. The extraction of key components of inhaled aerosols in this standard primarily considers the extraction study of components that come into long-term contact with drugs. On the basis of the extraction study of key components, further extraction studies of inhaled aerosol packaging systems can also be conducted, but such studies are generally used for further verification and confirmation rather than regulatory requirements. The extraction study of inhaled aerosol packaging materials can not only be used to screen the analytical methods used in the leachable study, establish the potential leachable spectrum under extreme conditions, and lay the necessary foundation for the leachable study and subsequent risk assessment, but also can be used to characterize the constituent materials of key components of the packaging system, establish routine quality monitoring of extractables, and conduct studies on possible changes to the packaging system. The preparation of this standard is primarily based on the existing packaging materials, production technologies, and analytical techniques in the domestic market. With the development and application of new materials and new technologies, as well as the advancement of modern analytical techniques, users can conduct research using other effective compatibility research methods according to actual