Physical Properties

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What is it?

Overview

Physical property testing ensures dosage forms like tablets, capsules, and sprays perform as intended. These tests confirm quality, consistency, and safety in compliance with Canadian standards.

Common Tests

Key Instruments Used

Analytical Balances

Essential for weight variation and average weight testing, offering high precision (to 0.1 mg) to detect even the smallest deviations in dosage unit mass. This ensures accurate, reliable, and regulated results using environmental controls, calibration, and secure data.

Disintegration Testers

Simulate conditions in the stomach or intestines to measure how quickly tablets or capsules break down. These instruments use baskets and beakers with controlled temperature and motion to provide precise, reproducible results.

Dissolution Apparatus

Standardized equipment used globally to assess the release profile of active ingredients. Typically includes rotating baskets (Apparatus I) or paddles (Apparatus II), automated sampling, and temperature control to mimic gastrointestinal fluids.

Sampling & Detectors

Automated sampling systems collect dissolution samples at precise intervals without interrupting the test, improving reproducibility and minimizing error. The drug release profiles are essential for demonstrating batch consistency, and regulatory compliance.

Applications Across Industries

Reference Methods

We adhere to established industry standards and reference methods, including ISO, Health Canada Standards, and other relevant guidelines. This ensures the reliability and comparability of our testing results. Our methods are continuously updated to reflect the latest advancements in materials testing.

FAQ

Frequently Asked Questions

What is the purpose of physical property testing?

To confirm that dosage forms like tablets, capsules, and sprays perform consistently, meeting safety and regulatory standards.

How do disintegration and dissolution differ?

Disintegration measures how fast a dosage form breaks apart, while dissolution measures how much and how quickly the active ingredient is released into solution.

Are these tests mandatory for Natural Health Products?

Yes. Health Canada requires NHPs to meet pharmacopeia standards for consistency and performance, not just pharmaceuticals.

Why are these tests important for pharmaceuticals?

They demonstrate bioavailability, bioequivalence, and batch consistency, which are essential for regulatory approval and patient safety.

Do food and beverage products need dissolution testing?

Yes, especially for fortified or functional foods, powders, and chewables, to ensure nutrients are released properly.

How do cosmetics or personal care items benefit from these tests?

Products like lozenges or effervescent tablets rely on disintegration and dissolution to verify consistent delivery of active ingredients.

Which reference methods are recognized in Canada?

Health Canada adopts USP standards alongside the Natural Health Products Regulations and Food and Drugs Act.

How often must instruments be calibrated?

Regular calibration is required under GMP to ensure accuracy, with documentation available for audits and inspections.

What is “Number of Discharges per Container” testing?

A method (coming soon) for sprays, pumps, and inhalers that confirms each actuation delivers a consistent dose throughout the container’s life.