Dissolution calibration parameters and criteria in pharma:
What is dissolution?
Dissolution is a rate of drug dissolution in the given set of conditions in a specified medium. Or It is a time required to dissolve the drug into a defined medium.
What are Dissolution calibration parameters and their criteria as per USP?
Dissolution is one of the important test in the pharmaceutical industry to understand the rate of drug dissolution. So it is very important to calibrate the instrument regularly to generate accurate results.
There are two major types of Dissolution calibration; 1. Physical Calibration and 2. Chemical Calibration.
The physical calibration parameters are as mentioned below;
Physical Calibration Parameters:
Parameter 1: Basket and Paddle Depth
Acceptance Criteria: The depth should be 25±2 mm for Basket and Paddle.
Parameter 2: Base Plate Level
Acceptance Criteria: The base plate inclination shall be NMT 0.5°
Parameter 3: Shaft Vertically
Acceptance Criteria: Deviation shall be NMT 0.5°
Parameter 4: Vessel Vertically
Acceptance Criteria: Deviation shall be NMT 0.5°
Parameter 5: Centering
Acceptance Criteria: The difference between the longest and smallest reading shall be NMT 1.0 mm from the center.
Parameter 6: Rotation per Minute
Acceptance Criteria: The RPM shall be ± 1 for the set value.
Parameter 7: Temperature
Acceptance Criteria: The Difference between the set temperature and observed temperature shall be NMT 0.5°C.
Parameter 8: Time
Acceptance Criteria: For 30 minutes ± 36 secs. and for 45 minutes ± 54 secs.
Parameter 9: Wobbling
Acceptance Criteria: The deflection of the probe tip shall be NMT 1.0 mm.
Parameter 10: Volume accuracy and replacement accuracy
Acceptance Criteria: For 10 mL sampled volume should be ±0.5 mL.
The calibration frequency for Physical parameters is 3 months.
Chemical Calibration Parameter:
Parameter: Prednisone tablet is used for chemical calibration.
Acceptance Criteria: The obtained results should be within the specified limit.
The frequency for chemical calibration is 6 months.
These are the dissolution calibration parameters and criteria used in the pharmaceutical industry to calibrate the dissolution instrument.
Dissolution calibration parameters and criteria in pharmaceuticals.
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