Extract and extract injection: Best Practices

Research thinks, the extract is pharmaceutical packaging materials were constructed or expanded force can extract chemical substances, can extract is defined in the conventional storage conditions, materials and drug exposure may be moved out of chemical substances. To extract the study is very important, because he may influence drug analysis, such as HPLC has the same retention time. Secondly, can extract may affect the diagnostic test, the impurity content is likely to exceed the acceptable level.

A general test including material identification, simulation studies, migration studies.

FDACDER for hermetic packaging system 4 requirements: protection, function, security, compatibility. At the same time, studies introduced a packaging and drug incompatibility of some examples, such as pharmaceutical active effect, active effect of packaging materials.

Compatibility study of note, in addition to the basic material, such as plastic, rubber, glass, general need to add some additives. Effect of package material can extract the type and quantity of many factors, including the package type, presence of amount of substance, material soluble, solvent system, solvent volume / packaging surface area, temperature, time.