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High Potent API Development

High Potent API Development

We are committed to provide our clients with the safe, scalable and phase appropriate solutions for high potent drug development.

We offer highly potent small molecule development services for API and intermediates, operating from our development facility in Hyderabad, India. The development lab can handle molecules with OEL 0.1 µg/m3. We have a systematic approach to managing High potent APIs. which makes us one of the safest partners of choice for all your discovery needs.

We can handle various potent molecules viz., heterocyclic, nucleosides, steroids and carbohydrates.

Our approach for HPAPI handling

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Dedicated HPAPI Labs

  • Self-equipped high potent chemical development lab with fume hoods (with negative pressure), barrier isolation, balance connected with isolator
  • Multi-purpose solids handling suites
  • High potent analytical labs with dedicated equipment connected with pass box
  • Biometric access control system
  • Capable to take up the development of HPAPI/Intermediates with OEL of 0.1µg/m³
  • Man-material entry and exit are separated to avoid contamination
  • Mist shower facility available for exit

Dedicated High Potent Analytical Lab

  • HPLC instrument with UV, DAD and CAD detectors
  • Gas chromatography with ALS and headspace injectors
  • Analytical balance (placed in Xpert filtered balance system)
  • pH meter
  • Ultrasound sonicator and rotary shaker
  • Zeta sizer
  • Isolator with HEPA cartridge for closed handling of the HPAI compounds
  • Pass box for sample transfer and atmos bag
  • Fume hood chemical handling and mobile phase preparations

Why Aurigene Pharmaceutical Services?

Integrated development and manufacturing

Dedicated analytical lab

Well-experienced team

Legacy of having developed and manufactured complex high potent products

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