Heavy Metal Analysis For Hemp: Know Your Specifications
The challenge of contaminants puts the hemp industry at an increased risk for negative health outcomes, particularly regarding exposure to heavy metals.
As such, it is imperative that manufacturers abide by the legally allowable hemp heavy metal limits through specifications development and heavy metal analysis of raw materials. Next, ensuring that specifications have been met through analytic and organic chemistry testing of raw materials provides accurate, reliable, and repeatable results against these pre-determined specifications.
Development of specifications is challenging. Sometimes a regulatory consultant experienced in specifications development and quality systems can help.
What is Heavy Metal Analysis for Hemp?
Specifications are a set of defined parameters benchmarked against acceptance criteria that define product characteristics and quality while supporting labeling and claims. Specifications testing is one of the biggest challenges for any industry, but particularly for the hemp-containing products industry.
Specifications define acceptable parameters for the hemp product. They also offer assurances that potentially harmful contaminants, like heavy metals, are either not present in the raw material or present within acceptably safe limits. Specifications testing confirms these parameters are met.
Once developed, specifications must be written and managed in a controlled system with revision histories that are tracked, monitored, reviewed, and approved by the Quality Assurance department.
The development of raw material specifications for hemp and appropriate tests to confirm that specifications have been met will help ensure you meet regulatory and quality standards.
How Are Specifications Developed?
Despite the clarity of intent, manufacturers continue to struggle with specifications development for hemp testing. Recognized test methods can be obtained from compendial sources like the following:
These can be used as a starting point when determining an appropriate method or developing a unique method for hemp heavy metal analysis when a compendial is unavailable.
Specifications are developed by first determining what finished product critical quality attributes will be achieved as well as the product’s acceptable ranges for identity, purity, quantity of dosage, and potency. When developing specifications, it is important to reference any sources referred to as these may be required to demonstrate regulatory compliance.
Once a specification is set, it must be verified using scientifically sound testing analysis and/or visual examination analysis such as the following:
- Organoleptic
- Macroscopic
- Microscopic
- Chemical
- Microbial
The term “scientifically sound” indicates the test is an appropriate choice to evaluate what is being tested, and that those results will ultimately demonstrate whether a product is safe.
Confirmation testing should also be conducted via an appropriate test method. Multiple tests and examinations are usually deployed to verify specifications, allowing for reproducibility and reliability of a finished product.
Specifications and Hemp Heavy Metal Testing
Metals are naturally occurring elements found in the air, water, and soil. Their concentrations are further influenced by things like the conditions in which the hemp plant is grown and manufacturing processes. Any consumption or topical use of products of botanical origin brings with it the inherent risk of exposure to heavy metals.
Through specifications development, manufacturers of hemp-containing products can ensure that critical limits for heavy metals and other contaminants are established as part of product development and quality control, and demonstrate that their product is safe, effective, and of high quality.
Through specification testing, manufacturers can then confirm their product’s safety by testing against pre-determined critical limits. Heavy metal analysis for hemp is just one among the many important tests that will confirm whether product specifications have been met.
Where Can I Get Hemp Heavy Metal Testing?
Laboratories able to handle controlled substances per a DEA registration, such as Labstat, can provide guidance for building appropriate specifications for raw ingredients such as hemp and ensure you use test methods that confirm identity, purity, strength, and potency. Find out more about our laboratory testing services for hemp here.
