In-Process Tests:
Weight Variation:
Measures the consistency of capsule fill weight.
Ensures uniform dosing of the drug.
Seal Integrity:
Assesses the sealing of the capsule shell to prevent leaks.
Moisture Content:
Monitored to ensure the gelatin shell remains pliable but not overly moist.
Final Product Tests:
Appearance:
Inspects capsules for uniformity in color, shape, and size.
Disintegration Test:
Determines the time required for the capsule shell to break down in simulated gastric or intestinal fluids.
Dissolution Test:
Measures the rate at which the drug is released from the capsule.
Content Uniformity:
Confirms that each capsule contains the labeled amount of drug within acceptable limits.
Microbial Testing:
Ensures the absence of microbial contamination.
Stability Testing:
Evaluates the shelf life of capsules under accelerated and long-term conditions.