BM Rao, PhD
Project Goal
Identify trace-level impurities in pharmaceuticals to ensure patient safety.
Challenges
The formation of impurities in pharmaceuticals is not limited to the degradation of active pharmaceutical ingredients (APIs) and their related impurities. Impurities are often observed in samples due to cross-contamination, leaching from packing materials and excipients and raw materials. Identification of trace-level impurities is a significant challenge and time-consuming activity. Quantification of trace-level genotoxic impurities (GTIs) in pharmaceuticals is crucial for patient safety.
Solution
An accurate mass spectrometry system from SCIEX helped us with many complex investigations, enabling us to identify unknown impurities with highly accurate and reliable mass data, which enables structure interpretation. Triple quadrupole systems are highly sensitive, allowing us to quantify trace-level impurities with results that were always reproducible and consistent.
Organization
Dr. Reddy's Laboratories, India
Organizational objectives
Deliver quality pharmaceutical products for everyone. Dr. Reddy’s Laboratories is committed to providing medicines that are safe, pure and efficacious and that adhere to quality standards and regulatory requirements.
SCIEX products
- TripleTOF 4600 system
- QTRAP 4500 system
- SCIEX 5500+ system
- QTRAP 6500+ system