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
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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.
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The scale up facility is equipped with negative pressure fume hoods and barrier isolation to handle HPAPI compounds.
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Dedicated Air handling units
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Dedicated effluent treatment management
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Multi-purpose solids handling suites for enhanced containment
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Dedicated high potent analytical labs with specialized equipment and pass box connectivity
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Biometric access control for strict security and safety
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Capable of developing HPAPIs and intermediates with OEL as low as 0.1 µg/m³
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Separate man-material entry and exit pathways to prevent cross-contamination
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Mist shower facility at exit points for enhanced safety
Dedicated High Potent Analytical Lab
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HPLC system with UV, DAD, and CAD detectors
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Gas Chromatography (GC) with ALS and headspace injectors
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Analytical balance integrated with an Xpert filtered balance system
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pH meter for precise measurements
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Ultrasound sonicator and rotary shaker for sample preparation
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Isolator with HEPA filtration for closed handling of HPAPI compounds
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Pass box & atmosphere bag for secure sample transfer
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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.
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