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Tag: study case
Case Study: Chemical Purity Analysis
2013-03-06 11:16:32| drugdiscoveryonline Downloads
Patheon conducted a study to challenge the claim that a PDA detector has the capability of detecting co-eluting components in HPLC peaks since this is based on UV spectroscopy, which is relatively nonspecific.
Tags: case
study
analysis
chemical
Case Study: Method Development and Validation
2013-03-06 11:12:08| drugdiscoveryonline Downloads
A customer came to Patheon needing clinical trial materials for their peptide product. When transferred to Patheon the validation of the HPLC methods was insufficient and poorly reproducible. This issue had the potential to delay the clinical trials and adversely affect the project’s overall timeline.
Tags: case
development
study
method
Case Study: Analytical Method Development And Validation
2013-03-06 11:09:16| drugdiscoveryonline Downloads
A medium-size pharmaceutical company approached Patheon to develop and validate a method for quantification of several potential genotoxic impurities (GTIs) in their drug substance. The customer’s procedure, which included a derivatization step prior to analysis, suffered from variable recovery.
Tags: case
development
study
method
Case Study: Custom Manufacturing
2013-03-05 18:17:43| drugdiscoveryonline Downloads
A client developed a suspension formulation in a viscous base with > 40% solids. The high viscosity resulted in fill weight variation that limited production speeds to less than 10,000 capsules per hour.
Tags: case
study
custom
manufacturing
Case Study: Quick To Market
2013-03-05 18:08:40| drugdiscoveryonline Downloads
Quick To Market™ is a unique Patheon-only program that offers accelerated transfer of commercially available products from an existing manufacturing plant to a plant within Patheon’s network. The program was formally established as a service within Patheon after excellent results and significant client satisfaction with recent rapid product transfers. Patheon can transition a non-sterile product into our network in six months, and a sterile product in eight months.
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