Cannabinoid ISOLATEs TESTING ABOVE 100% PURITY

Over recent years, ultra-purified CBD products have become increasingly more popular and are an integral part of CBD finished product manufacturing. Prior to going to market, these high-purity products are tested and can sometimes have results over 100% purity.

Finding a lab result over 100% purity can be confusing for many. This may be a new concept in the burgeoning CBD industry. CBD manufacturers and end users may not be familiar with this occurence. However, it is very common in scientific analysis. Values exceeding 100% have been measured for decades and will be measured for decades to come. This isn’t exclusive to CBD, THC, or any other cannabis product. This is consistent with scientific measurement practices.

BRIEF HISTORY

Historically, chemical compounds with 100% purity could only be accessed by professionals in scientific communities. Production of high-purity materials were limited to scientific institutions with very specific capabilities. Products manufactured to 100% purity and offered as consumer goods and products has been very limited prior to the inception of crystalline forms of cannabinoids. Rather, products are manufactured to a target value with a percentage of uncertainty around that target.

PHARMACEUTICAL INDUSTRY

The Pharmaceutical industry, one of the most tightly controlled industries in the world, manufactures products to a target value of plus or minus (±) a certain percent based on established criteria for the product type. The nomenclature of a pure drug substance is known as an Active Pharmaceutical Ingredient (API) and its Potency is referred to as an Assay value. Assay values that exceed 100% are not uncommon in the Pharmaceutical industry where formulators use pure API drug substances to which they add inactive ingredients, referred to as an excipient, to arrive at a target concentration of a formulated drug product. If a formulator uses an API with an Assay value of, say 100.9% for example, that formulator uses 100.9% in their calculation to formulate the product to a given target. This is such a normal and ubiquitous occurrence that the FDA expects to see Assay values for API’s and other chemical standards that exceed 100%.

UNITED STATES PHARMACOPIEA (USP)

In the Pharmaceutical industry, many standards of testing are outlined by the United States Pharmacopeia (USP), a non-profit entity that publishes standards for ingredient, products, and processes. They publish current versions of these standards annually and update standards as necessary.

The USP–NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics. The current version of USP–NF standards deemed official by USP are enforceable by the U.S. Food and Drug Administration for medicines manufactured and marketed in the United States. (https://www.uspnf.com/)

The USP lists standards specific to purified substances (e.g. ascorbic acid, ibuprofen, pseudoephedrine, etc.) as well as the finished drug products which are formulated from these substances in what are called monographs. While the USP is a non-governmental organization, the FDA considered these monographs (and other items contained in the current USP) as enforceable rule. The USP monographs describe the minimum tests substances or product must meet to be compliant in the United States. Americanna Laboratories uses many of the monographs and procedures outlined in the USP-NF compendiums.

QUESTIONS ANSWERED

Question: How can my product contain more than 100% CBD and how can any pharmaceutical product contain more than 100%?

Answer: The accumulation of uncertainty.

Theoretically, you can’t have more than 100% of anything. Scientifically, when you combine the uncertainty of the 1) Chemical Reference Standards, 2) Laboratory Processes, 3) Laboratory Equipment, and 4) Laboratory Personnel, the additive effect of uncertainty translates into the final Assay value which can derive values in excess of 100% for ultra-pure compounds.

The goal of any laboratory is to minimize the uncertainty to the best of their scientific ability. At Americanna Laboratories, we built our laboratory on the same foundation and protocols required in any FDA-compliant pharmaceutical quality control laboratory. Our laboratories have conducted FDA work within the pharmaceutical industry for over 25 years. Our facility has been audited by the FDA on numerous occasion and never found to have 483 deficiencies. We follow current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP), which allows us to provide the highest level of accuracy with the lowest levels of uncertainty.

Question: Why don’t you just change the lab report to say 100%?

Answer: Let’s say we test a CBD isolate and the value for CBD is 100.9%. While a CBD value of 100.9% may seem like an anomaly to the end user, it’s legally defensible and scientifically accurate. Every data point and calculation to derive at 100.9% stands on sound scientific principles. To merely change a number at the request of a manufacturer or end user because they aren’t experienced in these scientific practices would completely negate the defensibility of the data. Furthermore, manufacturers formulating products on a “fudge-factor” would be formulating inaccurately.

NO MORE CONFUSION

Values greater than 100% in the scientific community are simply accepted. Chemists, formulators, management, FDA auditors and the like, all understand this concept and have all accepted it for decades. New manufacturers and talent are entering this scientific community and in many cases have not been introduced to this concept.

Never before has a consumer product been manufactured, purified, and sold on the open market directly to consumers, so seeing a lab report with CBD results over 100% purity can be confusing to the layperson. If these products were being sold to scientific professionals, who intend to manufacture products from this as a starting material, they would simply use that Assay value in their formulations.