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Dissolution testing is a requirement for solid oral dosage forms throughout the development life-cycle and commercial manufacturing. Our services help understand the process in which a substance forms a solution and measure the extent and rate of solution formation from a dosage form, such as a tablet, capsule, ointment, etc.

Our scientific team has the experience to analyze and report the results as per current regulatory requirements.

Aurigene provides the following GMP services

  • Development and validation of dissolution procedures
  • Dissolution/drug release tests of different dosage forms
  • Two-stage dissolution with bio relevant media
  • Small scale dissolution study at preclinical stage

A dissolution test uses an apparatus with specific test conditions in combination with acceptance criteria to evaluate the performance of the product. General chapter <711> Dissolution includes four standardized devices: basket, paddle, reciprocating cylinder, and flow-through cell.

  • Basket: Used to determine the drug release from solid oral dosage forms
  • Paddle: Used to determine the drug release from solid/liquid oral dosage forms
  • Diffusion cell: Used to determine the drug release from semi-solids, derma products, etc.

The release of the drug can be analyzed by UV or HPLC instruments.

Aurigene Pharmaceutical Services is

a leading CRO/CDMO

that provides contract research and manufacturing services

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