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GMP Certification Program
Certified Quality Control ManagerSpeakersDr Corinne Bode
BayerDissolution TestingDevelopment/Quality Control and in vivo Relevance
26/27 June 2024 | Hamburg, Germany Dr Jan
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How to fill out dissolution testing - eca
How to fill out dissolution testing - eca
01
Prepare the dissolution medium according to the specifications mentioned in the ECA guidelines.
02
Set up the dissolution apparatus as per the standard operating procedure provided by ECA.
03
Place the dosage form in the dissolution medium in the apparatus.
04
Operate the apparatus at the specified temperature and speed as per ECA guidelines.
05
Take samples at regular intervals as directed by ECA and analyze them for drug release.
06
Record the dissolution profile and compare it with the acceptance criteria outlined in the ECA guidelines.
Who needs dissolution testing - eca?
01
Pharmaceutical companies manufacturing solid dosage forms need dissolution testing to ensure the quality and performance of their products.
02
Regulatory bodies such as the ECA require dissolution testing to assess the bioavailability and stability of drug products before approval for marketing.
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What is dissolution testing - eca?
Dissolution testing - eca is a method used to determine how quickly a drug substance dissolves in a specific medium.
Who is required to file dissolution testing - eca?
Pharmaceutical companies are required to file dissolution testing - eca for their drug products.
How to fill out dissolution testing - eca?
Dissolution testing - eca should be filled out according to the guidelines provided by regulatory authorities.
What is the purpose of dissolution testing - eca?
The purpose of dissolution testing - eca is to ensure the quality and effectiveness of drug products.
What information must be reported on dissolution testing - eca?
Information such as the formulation of the drug product, test conditions, and results must be reported on dissolution testing - eca.
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