Assessment of Extractables and Leachables Associated with Pharmaceutical Packaging

Technické články | 2019 | PerkinElmerZaměření
Farmaceutická analýza
Výrobce
PerkinElmer
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Bénédicte Gauriat1, Isabelle Froger2, Damien Chevaillier2, Hans-Joachim Huebschmann3Thermo Fisher Scientific, Les Ulis, France; 2Septodont, Dental Pharmaceutical Company,Saint-Maur-des-Fossés, France; 3Thermo Fisher Scientific, Singapore1Keywords: Pharmaceutical products, leachables, extractables, GCMS, identification, deconvolution, library searchIntroductionFrom manufacturing to administration, pharmaceuticalproducts come in contact with multiple...
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The Doctor Did Not Prescribe Irgafos:A Solution for Extractables and Leachables AnalysisThe world leader in serving science Outline• Introduction• Why conduct Extractables & Leachable (E&L) analysis?• Industries need Extractable & Leachable analysis• Regulations and guidelines from agencies and industry consortiums• Thermo...
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Analytical Workflow for Extractable and Leachable Impurities
2015|Thermo Fischer Scientific|Prezentace
Analytical Workflow for Extractable andLeachable ImpuritiesAAPS 2015 | 26 October 2015, Orlando FLKyle D’SilvaThe world leader in serving science WHAT areEXTRACTABLES and LEACHABLES?2 What is E&L testing for?3 Areas of concern4CONTAMINANTTOXICITYDRUGEFFICACYIs there risk of harmto the patient?Is there impact ondrug potency? Extractables & Leachables•...
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