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High Potent API Development Services High Potent API Development Services

High Potent API Development Services

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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Application and Manufacturing of High Potent Active Pharmaceutical Ingredient (HPAPI)

JANUARY 04, 2021

Application and Manufacturing of High Potent Active Pharmaceutical Ingredient (HPAPI)

High Potent Active Pharmaceutical Ingredient (HPAPIs) are majorly used to treat oncology-related conditions. Usually, a compound is considered high-potent when the operational exposure limit is below 10 µg/m3 of air as an 8-hour time-weighted average. High Potent drugs can be administrated through oral, injection or topical route depending on the source of the d...

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HPAPI Development at a Glance

The pharmaceutical industry's journey to improve patients' health has enhanced the number of more effective HPAPIs (High Potent Active Pharmaceutical Ingredient) in development pipelines. Traditionally, HPAPIs were exclusively concomitant with oncology therapeutics. ...

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Scalable alternate end-game strategies for the synthesis of the anti-COVID drug molecule Nirmatrelvir (1,PF-07321332) have been described. The first involves a direct synthesis of 1 via amidation of the carboxylic acid 7 (suitably activated as a mixed anhydride with either pivaloyl chloride or T3P) with the ...

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