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QTPP, CMA, CPP and CQA of Liquid Dosage Form


Quality Target Product Profile (QTTP) of Liquid Dosage Form

  • Dosage Form
  • Route of administration
  • Dosage Strength
  • Pharmacokinetics


Physical  

  • Appearance/Description
  • Weight/Volume
  • Viscosity
  • Container content/Net content
  • pH

Chemical
  • Impurities
  • Content uniformity
  • Assay


Packaging and storage 

  • Container closure system
  • Storage condition
  • Shelf life
  • Others (If required)


Critical Material Attributes (CMA) of Liquid Dosage Form

  • Particle size
  • Solubility
  • Water content


Critical Process Parameter (CPP) of Liquid Dosage Form

  • Order of material addition
  • Mixing time
  • Mixing speed
  • Mixing temperature
  • Homogenization speed


Critical Quality Attributes (CQA) of Liquid Dosage Form

  • Description/Appearance
  • Weight/Volume
  • Water content
  • Viscosity
  • pH
  • Assay
  • Impurities
  • Dissolution
  • Uniformity of dosage unit
  • Microbial limits
  • Others (if required)


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