and a brief summary of the specifications): Specifications (list parameters e.g. Packaging component Materials of construction identification (IR)) (b) Other information on the container closure system(s) (e.g. suitability studies): 2.3.S.7 Stability (name, manufacturer) 2.3.S.7.1 Stability Summary and Conclusions (name, manufacturer) Summary of stress testing (e.g. heat, humidity, oxidation, photolysis, acid/base): and results: Results (e.g. including discussion whether mass Stress condition Treatment balance and peak purity are observed) Heat Humidity Oxidation Photolysis Acid Base Other Summary of accelerated and long-term testing parameters (e.g. studies conducted): Storage condition Container closure Completed (and proposed) Batch number Batch size system testing intervals (◦C, % RH) Summary of the stability results observed for the above accelerated and long-term studies:
and a brief summary of the specifications): Packaging component Materials of construction Specifications (list parameters e.g. identification (IR)) (b) Other information on the container closure system(s) (e.g. suitability studies): 2.3.S.7 Stability (name, manufacturer) 2.3.S.7.1 Stability Summary and Conclusions (name, manufacturer) Summary of stress testing (e.g. heat, humidity, oxidation, photolysis, acid/base): and results: Stress condition Treatment Results (e.g. including discussion whether mass balance and peak purity are observed) Heat Humidity Oxidation Photolysis Acid Base Other Summary of accelerated and long-term testing parameters (e.g. studies conducted): Storage condition (◦C, % RH) Batch number Batch size Container closure system Completed (and proposed) testing intervals Summary of the stability results observed for the above accelerated and long-term studies:
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