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Agilent Practical Solutions Newsletter

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Welcome to Practical Solutions, your single, comprehensive source for the latest dissolution testing news, tools, and techniques. Register to receive future issues and download our latest edition now.

In this issue

Dissolution apparatus

Enhanced Mechanical Qualification of the Dissolution Apparatus and the Chinese Pharmacopeia

To ensure your dissolution apparatus is in proper working condition, a qualification procedure must be performed. A key element is the measurement of the physical parameter, regardless of which procedure is used [USP PVT or enhanced mechanical qualification (eMQ)]. The adoption of eMQ continues to spread around the globe. The Chinese FDA (now known as the National Medical Product Administration) recently published its recommended specifications. The 280-DS software now incorporates these guidelines for companies that chose to adhere to these guidelines.

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Dissolution Testing of Oral Suspensions:
What Needs to be Considered

Oral suspensions present unique dissolution testing challenges, because they are typically dosed as a liquid preparation containing solid particles dispersed in the liquid. Therefore, you should address the following considerations in your dissolution method:

  • Sample preparation
  • Density determination
  • Sample measurement
  • Sample introduction
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