Medical Marijuana, Inc. the first-ever publicly traded cannabis company in the United States that launched the world’s first-ever cannabis-derived nutraceutical products, brands and supply chain, announced today that the Company has reached a one-year milestone for long-term stability testing on its flagship THC-free cannabidiol (CBD) oil product Real Scientific Hemp Oil-X™ (RSHO-X™). The stability study was conducted in strict compliance with FDA/ICH guidelines (Q1A-R2).
“Our consumers and retail partners deserve the transparency and security of understanding how stable and dependable our products are throughout numerous climatic conditions and transportation scenarios,” said Medical Marijuana, Inc. CEO Dr. Stuart Titus. “This long-term study illustrates our deep commitment to creating and distributing safe, high-quality products to consumers worldwide and we aim to continue conducting similar studies in the future with our other industry leading CBD products.”
The stability study tested multiple samples of RSHO-X™ while being exposed to various environmental conditions that may be experienced in various locations throughout the world. The samples, which were tested for appearance, odor, specific gravity, viscosity, package compatibility, and complete microbial characteristics, showcased that the product is stable at the end of a one-year time period and has identical CBD concentrations to what existed at the beginning of the study.
The study was outsourced to one of the most qualified cGLP/cGMP compliant Contract Research Organizations (CROs) with attained ISO 17025 accreditation and certification.
It was performed using fully validated, proprietary analytical UPLC-PDA and LC-MS/MS methods reflecting the specificity and selectivity toward RSHO-X™, including data elements and parameters such as accuracy, precision, repeatability, ruggedness, system suitability, linearity, specificity, dilution integrity, and dynamic range.
The test results showed no change (no more than 5%) in the CBD content and other specifications were observed and the container closure system was faultless at both long-term and accelerated test conditions.
The positive 12-month, long-term stability test results suggest that RSHO-X™ is a stable formulation. The stability testing will be continued for up to 24 months and a corresponding shelf-life of 24 months is anticipated.