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
- 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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