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Process and Powder Safety Assessment Process and Powder Safety Assessment

Process and Powder Safety Assessment

Risk-free safety assured sustainable processes.

We are committed to the highest standards of Environment, Health and Safety. We follow a very robust and systematic approach to ensure risk assessment and safety studies. We also evaluate alternative options to adopt safer processes throughout our research from development to manufacturing and safe handling of powders. 

We offer process and powder safety assessment studies prior to manufacturing, irrespective of the phase of the molecule.

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Safety Assessment using Literature and Database

  • Review of the synthetic scheme for the potential hazards’ functionalities and gaseous by-products
  • Assessing the hazardous nature of reagents or solvents used for the conversions by referring to the available data such as material safety data sheet (MSDS) and Brethrick's handbook of reactive chemical hazards. Review of the reaction parameters such as temperature and pressure

Safety Assessment : Screening Tests and Instruments

  • Basic safety screening tests which include:
    • Differential scanning calorimetry (DSC) for reaction masses, organic layers, mixtures, intermediates, etc.
    • Thermal Screening Unit (TSU) studies
    • Reaction Calorimetry (RC1mx)
    • Accelerating Rate Calorimetry (ARC)
  • Powder safety studies which include:
    • Minimum ignition energy (MIE)
    • Bulk powder resistivity test
    • BAM Fall Hammer test
    • Burning behavior
    • Dust explosion

Why Aurigene Pharmaceutical Services?

Safety evaluation labs with infrastructure to support calorimetry, thermal screening and powder safety

Stringent SOPs for risk evaluation and stage wise risk assessment and safety reports

Assessed 500+ compounds

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The importance of business continuity planning in CRDMO industry

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Accelerating Drug Discovery Through Innovative Partnerships

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Physiochemical Characterization Services

Backed by our strong chemistry, we enable “Finger-print” protein structure and functional characterization for proteins from naked proteins to hyperglycosylated or derivatized proteins. ...

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Delivering 3 g dose of emetic and poorly bioavailable compound for 90 days repeated dose toxicity studies in dog

Background: Develop oral liquid dosage form of an IND candidate (small molecule) suitable for chronic toxicology studies in dogs. Must meet required systemic exposure and shall be dose proportional. Developed vehicle or used excipients shall be safe for chronic preclinical toxicology studies in dog. Challenges: Conventional suspension in dog resulted in low oral ...

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Construction of a quinoline ring via a 3-component reaction in water: crystal structure analysis and H-bonding patterns of a 2-aryl quinoline

2012

Montmorillonite K-10 mediated green and one-pot synthesis of 2-substituted quinolines has been accomplished via a 3-component reaction of aniline, aldehydes and ethyl 3,3- diethoxypropionate in the presence of air oxygen in water. The crystal structure analysis and H-bonding patterns of one compound prepared are presented. ...

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