CD Formulation performs a series of physicochemical tests to ensure that plastic drug containers are safe for potential extractables. For all the different polymers used to manufacture containers, physicochemical tests can be performed to find potentially extractable extracts from the containers. We can assess the quality of the drug by determining whether the drug container contains soluble, suspended, or particulate material that remains after the evaporation of the volatile solvent containing the drug through non-volatile residue (NVR) testing.
Non-volatile residue (NVR) is the soluble, suspended or particulate matter that remains after evaporation of the volatile solvent containing the substance. NVR determination is an important quality assurance test performed on products that contain any residue that may affect product quality and performance or process efficiency. NVR determination involves evaporation of the organic solvent followed by measurement of the residue by weight using a sensitive balance and a carefully tared weighing vessel. This analysis is the basic type of analysis used in the pharmaceutical industry.
Non-volatile residue (NVR) testing is performed by gravimetric analysis using extracts from aliquots of specimens. The extract is evaporated at a temperature below the boiling point of the solvent and then placed at a high temperature. The remaining residue is weighed and the results are compared to a standard. The test we provide is not an identification test and refers to how much non-volatile material is present in the extract.
Measuring non-volatile residues is a differential weight weighing application. The amount of non-volatile residue collected is usually very small. When the solvent purity is high, or when little contamination is present, very large volumes are required to provide very little residue. Weighing small sample volumes requires a high accuracy balance.
CD Formulation's business covers all aspects of drug formulation, drug ingredients, drug development, drug testing, drug optimization, etc. We provide one-stop integrated services from pre-clinical to commercial manufacturing for our global pharmaceutical and biotech partners. In the future, we will continue to strengthen our technological barriers and enhance our R&D production and service capabilities to provide quality and diversified services to more new drug development start-ups, medium and large companies as well as pharmaceutical companies around the world. If you have a requirement about our services, please contact us by phone or email, our colleagues will reply to you within three working days.