High Potent APIs

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 TirzPharm is dedicated to providing safe, scalable, and phase-appropriate solutions for the development of high-potential drugs. Our proficiency in creating highly potent small molecules for active pharmaceutical ingredients (APIs) and intermediates guarantees precision and safety throughout every phase of the process. 

Operating from our advanced facility, we manage molecules with an occupational exposure limit (OEL) as low as 0.1 µg/m³, adhering to a systematic approach to the management of high-potential drug substances (DS). This positions us as a reliable partner in the discovery and development of high-potency drug substances. Our expertise encompasses a wide array of potent molecules, including heterocyclic compounds, nucleosides, steroids, oncopeptides, carbohydrates, and prostaglandins, providing comprehensive support for intricate projects. 

• 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

• 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.