Overview
At NewAtom, we specialize in developing analytical methods based on the specific phase of drug development. Our Analytical Research and Development (AR&D) team has a deep understanding of the latest regulatory requirements, relevant chemistry, and critical analytical techniques. By meticulously following a systematic approach, we create efficient, accurate, and robust methods.
Our analysts closely collaborate with chemists and understand process details, raw material nature, reaction mass stability, dilutions and sampling for establishing In Process Controls (IPCs).
Leveraging our extensive experience, we design, develop and validate analytical methods for diverse compounds, including chiral and non-chromophoric substances. Our specialization extends to sensitive detection of elemental impurities, Potential Genotoxic impurities (PGIs) and Nitrosamines.
Our analytical team is competent in handling various chromatographic and spectroscopic techniques. They employ suitable techniques to quantify and qualify new chemical entities, drug substances, and related substances.
Our developed methods adhere rigorously to Standard Operating Procedures (SOPs) and ICH guidelines, subject to regular quality assurance reviews. Additionally, our expertise extends to developing stability indicating methods, forced degradation studies, chiral method development, impurity profiling, cleaning method validation, elemental impurities (as per ICH Q3D), and comprehensive method validation (as per ICH Q2R1). We also conduct stability studies in line with ICH Q1R2.
List of analytical instruments
- HPLC/ MPLC/UPLC
- Gas Chromatography (GC) (HS & ALS)
- FT-IR Spectrophotometer
- Polarimeter
- Metrohm KF Titrator
- Total Organic Carbon (TOC)
- Stability Chambers
- Tapped density tester
- Particle size analyzer
- BOD incubators
- Biosafety cabinet
- LAF
- Air Sampler
Plot No: 1217/A, Veda Ark
3rd Floor, Road No: 36, Jubilee Hills
Hyderabad, Telangana, 500033, IN
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040-29707789
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