High Potent API (HPAPIs)
CRAMSN Research Park is committed to delivering safe, scalable, and phase-appropriate solutions for high-potent drug development. Our expertise in developing highly potent small molecules for APIs and intermediates ensures precision and safety at every stage.
Operating from our state-of-the-art facility, we handle molecules with OEL as low as 0.1 µg/m³, following a systematic approach to high-potent DS management. This makes us a trusted partner for discovery and development of high potent drug substances.
Our capabilities extend across a diverse range of potent molecules, including heterocyclic compounds, nucleosides, steroids, onco-peptides and carbohydrates, prostaglandins etc ensuring comprehensive support for complex projects.
Our Approach for HPAPI handling
State-of-the-Art HPAPI Labs
Advanced High Potent Chemical Development Lab
- Self-contained high potent chemical development research laboratory with multiple isolators for various operations while performing the reaction , workup, distillation, crystallisation, isolation, drain, and post isolation processes.
- The scale up facility is equipped with negative pressure fume hoods and barrier isolation to handle HPAPI compounds.
- Dedicated Air handling units
- Dedicated effluent treatment management
- Multi-purpose solids handling suites for enhanced containment
- Dedicated high potent analytical labs with specialized equipment and pass box connectivity
- Biometric access control for strict security and safety
- Capable of developing HPAPIs and intermediates with OEL as low as 0.1 µg/m³
- Separate man-material entry and exit pathways to prevent cross-contamination
- Mist shower facility at exit points for enhanced safety
Dedicated High Potent Analytical Lab
- HPLC system with UV, DAD, and CAD detectors
- Gas Chromatography (GC) with ALS and headspace injectors
- Analytical balance integrated with an Xpert filtered balance system
- pH meter for precise measurements
- Ultrasound sonicator and rotary shaker for sample preparation
- Isolator with HEPA filtration for closed handling of HPAPI compounds
- Pass box & atmosphere bag for secure sample transfer
- Fume hood for chemical handling and mobile phase preparation
Our cutting-edge HPAPI labs ensure safe, compliant, and efficient development of highly potent compounds, adhering to stringent regulatory and containment standards.
Why CRAMSN High Potent API Development Services?
Integrated development and manufacturing
Dedicated analytical lab
Well-experienced team
Legacy of having developed and manufactured complex high potent products
Advance Toward Formulation and Delivery :
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