Impurity isolation and sample purification
RSSL is now offering a service in preparative HPLC to help customers isolate impurities and also purify reference standards
RSSL is now offering a service in preparative HPLC to help customers isolate impurities and also purify reference standards.
During a stability study – a service also offered by RSSL – unexpected and unknown impurities may arise in a sample, and these need to be isolated and identified. RSSL’s preparative HPLC service can isolate sufficient impurity for identification purposes. Highly sophisticated techniques, such as Nuclear Magnetic Resonance spectrometry, Fourier Transform-infra-red spectroscopy and Mass Spectrometry are available at RSSL’s laboratories for this, meaning that RSSL can offer a complete end to end service for both isolating and identifying impurities.
The preparative HPLC at RSSL is also suitable for isolating reference standard-quality material. Depending on the sample, a few grams of reference standard can be produced. RSSL can then also fully characterise this and establish it as a Primary Reference Standard.
The service is appropriate for small and large molecules, meaning it has applications for both traditional pharma and biopharma customers.
Impurity identification and sample purification are both essential aspects of pharmaceutical development, and these services are an important addition to the support that RSSL can offer customers in this area, whether that be for existing compounds or New Chemical/Biological Entities.