Beginning January 1, 2024, state licensed laboratories are required to use the Department of Cannabis Control’s (DCC) standardized cannabinoids test method and standardized operating procedures for testing dried flower, including non-infused pre-rolls. Below is a list of frequently asked questions.
Can my laboratory change the instrument method parameters (e.g. wavelength, flow rate, injection volume) from those listed in the SOP?
As stated in the SOP, instrument parameters may be adjusted to your HPLC system. You may alter the instrument conditions such as wavelength, flow rate, and injection volume to optimize the method on your system. Please ensure your parameters and column can achieve equivalency with a minimum resolution of 1.3.
Can my laboratory choose a different column than the one listed in the SOP?
As stated in the SOP, you may use an equivalent column that can separate the cannabinoids of interest with a resolution of 1.3. The descriptors listed in a column name refer to the stationary phase, particle size, diameter, and length of the column. You may compare these values to assess how similar your column is to the one listed in the SOP. Ensure your chosen column can achieve the equivalent resolution of 1.3.
Can I use the standardized method with other matrices?
As stated in section 15712.1, the standardized method is only required for the analysis of flower and non-infused pre-rolls. If your laboratory would like to analyze other matrices or add additional analytes with this method, please perform a full method validation for the additional analytes or matrices in accordance with section 15713. Please note that sample mass requirements for matrices not covered by the new standardized method SOP (e.g. edibles, concentrates) still remains 0.5 grams pursuant to 4 CCR 15724.
Can my laboratory change the calibration curve in the SOP?
The stated calibration curve, including required standard concentrations, cannot be altered. As stated in the SOP, the 0.5, 2, 5, 10, 20, 50 and 100 ppm calibration standards are the minimum required calibration levels. These levels must be included in the calibration curve. You may include additional calibration levels from those listed above.
Does “certified reference materials” listed in section 15712.1 refer to an in-matrix CRM, with recovery of 80-120%?
In this case, certified reference materials is in regards to the standards (e.g. see SOP page 4 of 12). It is not the intention of the verification to require an in-matrix CRM as listed in 4 CCR 15713. The new verification requirements supersede the previously used validation requirements for flower and non-infused pre-rolls. The performance of an in-matrix CRM is not required for the verification.
Can the matrix spiked samples used for the method verification be prepared as matrix post-dilution spikes?
No, spiked samples in the method verification should be spiked prior to extraction. The verification samples should be spiked at 2 concentration levels, with 3 replicates each, per section 15712.2(d).
As a reminder, US FDA’s Guidelines for the Validation of Chemical Methods for the FDA FVM Program, 2nd edition defines a matrix spike as an aliquot of a sample prepared by adding a known amount of analyte(s) to a specified amount of matrix. A matrix spike is subjected to the entire analytical procedure to establish if the method is appropriate for the analysis of a specific analyte(s) in a particular matrix.
After extraction, a spiked sample should be analyzed by injection on the instrument. If additional dilutions are needed to quantify the sample using your calibration curve, perform as needed. Verification samples that are not spiked at 2 concentration levels with 3 replicates prior to extraction will need to be re-performed using the required matrix spiked samples.
How much sample should be weighed for analysis?
The laboratory should weigh 200 mg to the nearest 0.1 mg. The SOP requires the use of an analytical balance with weighing capabilities to the nearest 0.1 mg.
Can my laboratory use a different blank matrix than the one listed in the SOP?
No, please use cellulose powder. Verifications that use a different blank matrix will need to be re-performed using the required cellulose powder.
Can laboratories de-stem a collected flower sample for testing?
No. All sample increments collected must be homogenized prior to sample analyses, notwithstanding foreign material testing, pursuant to 4 CCR section 15714(a). There are no provisions in regulations to remove stems or any other material from the sample increments. Please homogenize the entire collected sample to perform the test method.
Can laboratories go straight from the filtrate (0.2 grams into 40mL) to a dilution for analysis?
No. Laboratories cannot go straight from extraction into dilution (20x) without vialing and analyzing the initial extraction. Samples may be diluted and re-injected as needed to meet quantification requirements. If your laboratory is not injecting the extracted sample, please update your laboratory’s SOP to ensure the initial sample extraction is analyzed in addition to any sample dilutions. Please send the updated SOP to TestingLabs@cannabis.ca.gov .
View a copy of the regulations on the rulemaking page: Standard cannabinoids test method and standardized operating procedures