Developing Robust Standardised Analytical Procedures for Cannabinoid Quantification: Laying the Foundations for an...

Area of Science:

• Pharmacology
• Analytical Chemistry
• Botany

Background:

• Cannabis produces unique, pharmaceutically relevant metabolites called cannabinoids.
• The expanding cannabis-based pharmaceutical industry requires robust quantification methods.
• Existing analytical methods for cannabinoids lack widespread validation according to international guidelines.

Purpose of the Study:

• To critically discuss validation parameters for standardized cannabinoid quantification methods.
• To identify obstacles in developing reliable analytical procedures for cannabis-based drugs.
• To propose solutions for analytical method standardization in the cannabis industry.

Main Methods:

• Critical discussion of validation parameters for cannabinoid quantification.
• Evaluation of specificity, accuracy, and inter-laboratory precision.
• Review of challenges in regulatory environments for botanical drug development.

Main Results:

• Few existing cannabinoid quantification methods are validated using international guidelines.
• Standardized methods are needed for various manufacturing stages and processing levels.
• Challenges include matrix heterogeneity, accuracy, reproducibility, and regulatory volatility.

Conclusions:

• Standardized analytical methods are essential for the cannabis pharmaceutical industry.
• Overcoming validation hurdles requires addressing specificity, accuracy, and precision.
• A collaborative research initiative is proposed to tackle standardization barriers.