Service Page

Dissolution Machine Calibration

Introduction

Dissolution testing is a critical quality control procedure used in the pharmaceutical industry to assess the rate and extent at which active ingredients in solid dosage forms, such as tablets and capsules, are released into solution. This process ensures that medications provide consistent therapeutic effects.

1. Physical Calibration

Physical calibration ensures the mechanical and operational parameters of the dissolution apparatus meet required specifications. The following parameters are typically calibrated:

Rotation Speed of the Paddles or Baskets: This ensures the machine matches the set rotation speed.
Temperature of the Dissolution Medium: The medium must maintain a temperature of 37°C ± 0.5°C.
Alignment of the Paddles or Baskets: Proper alignment ensures even mixing and accurate dissolution rates.
Vessel Dimensions and Shape: The vessels must meet specific geometry standards.
Depth of the Paddle/Basket in the Solution: Correct positioning ensures the drug is properly exposed to the medium.

2. Chemical Calibration (Using Prednisone Tablets)

Chemical calibration is conducted using Prednisone Tablets as a reference standard, ensuring the performance of the machine under test conditions. It involves:

Preparation of the Dissolution Medium: A standardized buffer solution is prepared.
Dissolution Test Run: Prednisone tablets are tested in the machine under standard conditions.
Sampling: Samples are collected at specified intervals and analyzed.
Comparison to Reference Values: Results are compared to reference values provided by regulatory authorities like the USP.

Chemical calibration ensures the system performs well under operational conditions, verifying that the machine can accurately simulate the release of the drug into solution.

Conclusion

Regular calibration, both physical and chemical, is vital to maintaining the integrity of dissolution tests. Physical calibration ensures mechanical aspects are within limits, while chemical calibration confirms real-world performance using Prednisone Tablets. Together, these processes help guarantee medication quality and consistency.