Manufacturing Batch Release

Unknown peaks in chromatograms for the analysis of batch release or stability testing is not unusual. Different compounds can appear for various reasons, such as laboratory contaminations, instrumental- related peaks, leachable and impurities.

RPS provides identification of unknown organic compounds appearing in any kind of chromatogram for Pharmaceutical testing:

• Impurity profiling
• Unknown peaks occurring during method development
• Unknown peaks occurring during API, batch release and stability testing.

Swift identification allows for critical situations to be addressed, avoiding potentially high additional costs and use of resources. This is especially useful in cases where it is not possible to conclude whether the unknown compound is present in the product.

Proper identification of substances coming from contaminations is a precious tool for successful completion of the investigations and implementation of effective CAPAs.

As compliance requirements become tighter, our innovative approach offers the unique opportunity to have a service which is readily available, and where results are provided in five working days. This significantly increases the possibilities for Quality Assurance teams to focus on complicated situations.

RPS is committed to providing tailored solutions to client specific needs, while avoiding activities that may not be necessary for a given project. We consider absolute confidentiality to be a top priority in our business; strict confidence is core part of our professional ethics. Our analytical team work to the highest possible quality standards and provide a competitive service with a prompt turnaround of results.

Turnaround times

RPS provide elemental composition in five working days allowing for critical problems deriving from Out of Specification unknown peaks to be addressed.

Quality standards

Our scientific approach to qualitative analysis includes robust quality criteria, set to the highest quality standards to confer high levels on confidence to results.

Confidentiality

Our policies focus specifically on guaranteeing maximum confidentiality for our customers’ sensitive information.