ASTM-D8375 2023

$37.38

D8375-23 Standard Test Method for Determination of Cannabinoid Concentration in Dried Cannabis and Hemp Raw Materials using Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)

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ASTM	2023	17

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Categories: 11.120.99 - Other standards related to pharmaceutics, ASTM

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Description

ASTM D8375-23

Active Standard: Standard Test Method for Determination of Cannabinoid Concentration in Dried Cannabis and Hemp Raw Materials using Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)

ASTM D8375

Scope

1.1 This test method allows for the concentration determination of the cannabinoids listed in Table 1, and shall apply to any dried raw material from a cannabis plant (Note 1, Note 2) regardless of the type of cannabis plant from which it was derived.2 For the sake of brevity, the term “cannabis” shall be used from now on to refer to any type of cannabis plant including those that can be classified as hemp. The procedure includes sub-sampling a ground, homogeneous sample, extraction with methanol:water (80:20, v:v),3^,4 dilution in methanol and analysis by liquid chromatography tandem mass spectrometry (LC-MS/MS). The method allows for a wide-range of sample concentrations to be determined by using a 1000-fold calibration range and the option to perform multiple levels of sample dilution. The calibration curve is prepared in methanol over a range of 10 ng/mL to 10 000 ng/mL for all seventeen cannabinoids, or a subset of cannabinoids if desired, while the sample extracts are diluted in methanol into the calibration range.3^,4^,5 For example, a 1/500 dilution of sample extracts allows concentration determination over a range of 0.5 mg/g to 500 mg/g in cannabis. The method was validated with quality control samples prepared in methanol, a candidate certified reference material (CRM), and repeat extraction and analysis of cannabinoid samples.3

Note 1: For this test method, dried raw material from a cannabis plant includes one or more of inflorescence, leaves, or stems.

Note 2: Certain jurisdictions or regulations may require specific parts of the plant to be included or excluded for analysis and those regulations will take precedence for the selection of plant parts.

1.2 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.3 List of Measurable Analytes—See Table 1.

1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Keywords

analyses; cannabinoids; cannabis; hemp; laboratory; LC-MS/MS

QC SampleQC-LLOQ(ng/mL)QC-1(ng/mL)QC-2(ng/mL)QC-3(ng/mL)HempCRM(mg/g)Cannabis CRM(mg/g)HEMPRRSRecoveryCannabisRRSRecovery1030150080000.31848.9(%)(%)Batch-1n666666—Av.8.4127.8147474280.27950.3–Precision (%)0.7 %1.5 %0.8 %0.2 %0.5 %0.9 %–Accuracy (%)84.1 %92.5 %98.3 %92.8 %87.8 %103.0 %–Batch-2n666666—Av.9.1729.2152976440.27846.0–Precision (%)1.0 %1.3 %0.6 %0.8 %0.8 %%–Accuracy (%)91.7 %97.5 %101.9 %95.6 %87.3 %94.0 %–Batch-3n6666661-Av.9.0027.6150373680.27546.3–Precision (%)1.1 %0.6 %0.5 %0.3 %0.9 %0.7 %–Accuracy (%)90.0 %92.1 %100.2 %92.1 %86.4 %94.8 %95.6 %-QC sample Inter-Batch Statsn181818181818–Av.8.8628.2150274800.2847.6–Precision (%)3.9 %2.9 %1.6 %1.7 %1.0 %5.0 %–Accuracy (%)88.6 %94.0 %100.1 %93.5 %87.2 %97.3 %– QC SampleQC-LLOQ(ng/mL)QC-1(ng/mL)QC-2(ng/mL)QC-3(ng/mL)HempCRM(mg/g)Cannabis CRM(mg/g)HEMPRRSRecoveryCannabisRRSRecovery1030150080000.979124(%)(%)Batch-1n666666–Av.8.8328.1146774371.01119–Precision (%)2.2 %1.3 %0.3 %0.8 %1.0 %1.2 %–Accuracy (%)88.3 %93.6 %97.8 %93.0 %102.8 %95.9 %–Batch-2n666666–Av.9.0729.1150775640.961106–Precision (%)1.0 %0.9 %0.4 %1.0 %1.2 %3.0 %–Accuracy (%)90.7 %97.0 %100.5 %94.6 %98.1 %85.3 %–Batch-3n666666–Av.9.127.3152073580.970111–Precision (%)2.2 %1.7 %0.6 %0.8 %1.4 %0.4 %–Accuracy (%)91.3 %91.0 %101.3 %92.0 %99.1 %89.5 %–QC sample Inter-Batch Statsn181818181818–Av.9.0128.2149874530.979112–Precision (%)2.3 %3.0 %1.6 %1.4 %2.4 %5.3 %–Accuracy (%)90.1 %93.8 %99.9 %93.2 %100.0 %90.2 %– QC SampleQC-LLOQ(ng/mL)QC-1(ng/mL)QC-2(ng/mL)QC-3(ng/mL)HempCRM(mg/g)Cannabis CRM(mg/g)HEMPRRSRecoveryCannabisRRSRecovery1030150080005.418.33(%)(%)Batch-1n666666–Av.8.927.8146576345.158.60–Precision (%)3.1 %2.3 %0.5 %1.2 %1.2 %1.9 %–Accuracy (%)88.6 %92.7 %97.7 %95.4 %95.3 %103.2 %–Batch-2n666666–Av.9.428.8149176515.077.59–Precision (%)5.1 %1.2 %0.6 %1.0 %1.5 %3.8 %–Accuracy (%)94.2 %96.0 %99.4 %95.6 %93.7 %91.2 %–Batch-3n666666–Av.9.227.5149474835.047.97–Precision (%)4.6 %1.1 %0.9 %1.5 %1.1 %2.1 %–Accuracy (%)92.5 %91.8 %99.6 %93.5 %93.2 %95.7 %–QC sample Inter-Batch Statsn181818181818Av.9.1828.1148375895.098.06–Precision (%)4.9 %2.5 %1.1 %1.6 %1.5 %5.9 %–Accuracy (%)91.8 %93.5 %98.9 %94.9 %94.0 %96.7 %– QC SampleQC-LLOQ(ng/mL)QC-1(ng/mL)QC-2(ng/mL)QC-3(ng/mL)HempCRM(mg/g)Cannabis CRM(mg/g)HEMPRRSRecoveryCannabisRRSRecovery10301500800014.623.0(%)(%)Batch-1n666666–Av.9.127.61462758413.523.5–Precision (%)3.1 %2.8 %1.4 %1.7 %2.0 %1.8 %–Accuracy (%)90.8 %91.9 %97.4 %94.8 %92.3 %102.1 %–Batch-2n666666–Av.9.228.71500768413.420.2–Precision (%)2.9 %2.2 %0.9 %1.0 %1.7 %4.0 %–Accuracy (%)92.1 %95.6 %100.0 %96.1 %91.5 %87.7 %–Batch-3n666666–Av.9.227.71529742013.422.2–Precision (%)2.5 %2.8 %0.7 %1.4 %2.2 %1.6 %–Accuracy (%)91.8 %92.4 %101.9 %92.8 %92.0 %96.4 %–QC sample Inter-Batch Statsn181818181818–Av.9.1628.01497756313.421.9–Precision (%)2.7 %3.1 %2.1 %2.0 %1.9 %6.8 %–Accuracy (%)91.6 %93.3 %99.8 %94.5 %91.9 %95.4 %– QC SampleQC-LLOQ(ng/mL)QC-1(ng/mL)QC-2(ng/mL)QC-3(ng/mL)HempCRM(mg/g)Cannabis CRM(mg/g)HEMPRRSRecoveryCannabisRRSRecovery1030150080000.0482.14(%)(%)Batch-1n666666–Av.9.027.6143175720.03831.70–Precision (%)2.0 %1.2 %0.8 %0.5 %2.9 %0.8 %–Accuracy (%)90.5 %92.1 %95.4 %94.6 %80.1 %95.5 %–Batch-2n666666–Av.9.528.7148177630.03821.59–Precision (%)1.6 %1.4 %1.2 %1.1 %1.9 %1.9 %–Accuracy (%)95.4 %95.7 %98.7 %97.0 %80.0 %89.6 %–Batch-3n6666661-Av.9.026.8149875620.03831.60–Precision (%)2.2 %1.5 %1.1 %0.7 %1.2 %1.8 %–Accuracy (%)89.7 %89.4 %99.8 %94.5 %80.2 %90.0 %102.1-QC sample Inter-Batch Statsn181818181818–Av.9.1827.7147076320.0381.63–Precision (%)3.4 %3.1 %2.2 %1.5 %2.0 %3.3 %–Accuracy (%)91.8 %92.4 %98.0 %95.4 %80.1 %91.7 %– QC SampleQC-LLOQ(ng/mL)QC-1(ng/mL)QC-2(ng/mL)QC-3(ng/mL)HempCRM(mg/g)Cannabis CRM(mg/g)HEMPRRSRecoveryCannabisRRSRecovery1030150080000.1173.89(%)(%)Batch-1n666666–Av.8.527.9146473920.1103.97–Precision (%)0.9 %1.0 %0.7 %0.9 %1.5 %1.0 %–Accuracy (%)84.9 %92.9 %97.6 %92.4 %93.9 %102.1 %–Batch-2n666666–Av.9.329.2150974870.1063.53–Precision (%)2.1 %1.1 %0.6 %0.8 %1.5 %3.3 %–Accuracy (%)93.2 %97.4 %100.6 %93.6 %90.7 %90.6 %–Batch-3n6666661-Av.8.927.6151874260.1073.76–Precision (%)2.5 %1.4 %0.4 %0.6 %0.9 %0.7 %–Accuracy (%)89.4 %91.9 %101.2 %92.8 %91.6 %96.5 %103.5-QC sample Inter-Batch Statsn181818181818–Av.8.9128.2149774350.1083.75–Precision (%)4.3 %2.9 %1.7 %0.9 %2.0 %5.3 %–Accuracy (%)89.1 %94.1 %99.8 %92.9 %92.1 %96.4 %– QC SampleQC-LLOQ(ng/mL)QC-1(ng/mL)QC-2(ng/mL)QC-3(ng/mL)HempCRM(mg/g)Cannabis CRM(mg/g)HEMPRRSRecoveryCannabisRRSRecovery103015008000–(%)(%)Batch-1n6666—-Av.9.027.514177617—-Precision (%)3.9 %1.8 %0.8 %0.7 %—-Accuracy (%)89.9 %91.5 %94.5 %95.2 %—-Batch-2n6666—-Av.9.728.414727775—-Precision (%)1.7 %1.4 %1.1 %0.9 %—-Accuracy (%)97.1 %94.6 %98.1 %97.2 %—-Batch-3n6666–11Av.9.226.714747643—-Precision (%)3.7 %1.8 %1.2 %0.8 %—-Accuracy (%)92.4 %89.2 %98.3 %95.5 %–98.497.0QC sample Inter-Batch Statsn18181818—-Av.9.3227.514547678—-Precision (%)4.5 %3.0 %2.1 %1.2 %—-Accuracy (%)93.2 %91.8 %97.0 %96.0 %—- QC SampleQC-LLOQ(ng/mL)QC-1(ng/mL)QC-2(ng/mL)QC-3(ng/mL)HempCRM(mg/g)Cannabis CRM(mg/g)HEMPRRSRecoveryCannabisRRSRecovery103015008000–(%)(%)Batch-1n6666—-Av.8.528.914977238—-Precision (%)3.1 %0.9 %1.2 %1.3 %—-Accuracy (%)85.5 %96.2 %99.8 %90.5 %—-Batch-2n6666—-Av.9.230.315637395—-Precision (%)1.9 %2.0 %0.9 %1.1 %—-Accuracy (%)92.0 %101.0 %104.2 %92.4 %—-Batch-3n6666–11Av.8.928.715627203—-Precision (%)1.9 %0.6 %0.5 %0.7 %—-Accuracy (%)88.8 %95.7 %104.1 %90.0 %–102.5102.5QC sample Inter-Batch Statsn18181818—-Av.8.8829.315417278—-Precision (%)3.8 %2.8 %2.2 %1.5 %—-Accuracy (%)88.8 %97.7 %102.7 %91.0 %—- QC SampleQC-LLOQ(ng/mL)QC-1(ng/mL)QC-2(ng/mL)QC-3(ng/mL)HempCRM(mg/g)Cannabis CRM(mg/g)HEMPRRSRecoveryCannabisRRSRecovery1030150080000.4903.39(%)(%)Batch-1n666666–Av.8.927.1142675750.4613.70–Precision (%)2.3 %2.0 %0.7 %0.6 %1.1 %0.9 %–Accuracy (%)88.6 %90.5 %95.1 %94.7 %94.0 %109.2 %–Batch-2n666666–Av.9.628.7148777670.4533.41–Precision (%)1.4 %1.0 %0.3 %0.8 %1.7 %4.7 %–Accuracy (%)95.8 %95.5 %99.1 %97.1 %92.5 %100.6 %–Batch-3n6666661-Av.9.327.4148975330.4593.30–Precision (%)1.5 %0.9 %0.5 %0.3 %1.0 %0.4 %–Accuracy (%)93.4 %91.5 %99.3 %94.2 %93.6 %97.4 %96.2-QC sample Inter-Batch Statsn181818181818–Av.9.2627.7146776250.4583.47–Precision (%)3.7 %2.7 %2.1 %1.5 %1.4 %5.6 %–Accuracy (%)92.6 %92.5 %97.8 %95.3 %93.4 %102.4 %– QC SampleQC-LLOQ(ng/mL)QC-1(ng/mL)QC-2(ng/mL)QC-3(ng/mL)HempCRM(mg/g)Cannabis CRM(mg/g)HEMPRRSRecoveryCannabisRRSRecovery1030150080000.3501.84(%)(%)Batch-1n666666–Av.8.728.7148874710.3652.11–Precision (%)4.4 %2.5 %0.8 %1.2 %1.8 %3.1 %–Accuracy (%)87.4 %95.6 %99.2 %93.4 %104.2 %114.4 %–Batch-2n666666–Av.8.729.1151075650.3371.86–Precision (%)4.9 %2.7 %1.4 %0.8 %2.6 %4.5 %–Accuracy (%)87.4 %97.1 %100.7 %94.6 %96.2 %101.3 %–Batch-3n6666661-Av.9.028.3151373320.3401.88–Precision (%)3.6 %3.3 %0.9 %1.4 %1.8 %2.0 %–Accuracy (%)90.2 %94.3 %100.9 %91.7 %97.3 %101.9 %103.8-QC sample Inter-Batch Statsn181818181818–Av.8.8328.7150474560.3471.95–Precision (%)4.3 %2.9 %1.3 %1.7 %4.1 %6.7 %–Accuracy (%)88.3 %95.7 %100.2 %93.2 %99.2 %105.9 %– QC SampleQC-LLOQ(ng/mL)QC-1(ng/mL)QC-2(ng/mL)QC-3(ng/mL)HempCRM(mg/g)Cannabis CRM(mg/g)HEMPRRSRecoveryCannabisRRSRecovery103015008000–(%)(%)Batch-1n6666—-Av.8.627.014477629—-Precision (%)2.7 %1.0 %1.1 %0.5 %—-Accuracy (%)85.7 %90.1 %96.5 %95.4 %—-Batch-2n6666—-Av.9.628.814727755—-Precision (%)4.8 %2.4 %1.6 %1.3 %—-Accuracy (%)96.3 %96.0 %98.1 %96.9 %—-Batch-3n6666–11Av.9.227.114837395—-Precision (%)3.8 %1.4 %1.5 %1.0 %—-Accuracy (%)92.0 %90.5 %98.9 %92.4 %–100.799.9QC sample Inter-Batch Statsn18181818—-Av.9.1327.714677593—-Precision (%)6.1 %3.4 %1.7 %2.2 %—-Accuracy (%)91.3 %92.2 %97.8 %94.9 %—- QC SampleQC-LLOQ(ng/mL)QC-1(ng/mL)QC-2(ng/mL)QC-3(ng/mL)HempCRM(mg/g)Cannabis CRM(mg/g)HEMPRRSRecoveryCannabisRRSRecovery1030150080000.3251.18(%)(%)Batch-1n666666–Av.9.027.1141377560.2761.03–Precision (%)3.4 %2.1 %0.9 %0.6 %1.6 %3.0 %–Accuracy (%)89.6 %90.3 %94.2 %97.0 %85.1 %100.7 %–Batch-2n666666–Av.9.328.9145778780.2681.04–Precision (%)3.4 %1.7 %0.9 %1.1 %0.8 %1.9 %–Accuracy (%)92.7 %96.5 %97.1 %98.5 %82.5 %101.9 %–Batch-3n66666611Av.9.627.3143576300.2681.03–Precision (%)4.2 %1.9 %0.7 %0.5 %1.4 %1.1 %–Accuracy (%)96.2 %91.1 %95.7 %95.4 %82.5 %101.4 %93.089.4QC sample Inter-Batch Statsn181818181818–Av.9.2927.8143577550.2711.03–Precision (%)4.6 %3.5 %1.5 %1.5 %1.9 %2.0 %–Accuracy (%)92.9 %92.6 %95.7 %96.9 %83.4 %101.3 %– QC SampleQC-LLOQ(ng/mL)QC-1(ng/mL)QC-2(ng/mL)QC-3(ng/mL)HempCRM(mg/g)Cannabis CRM(mg/g)HEMPRRSRecoveryCannabisRRSRecovery1030150080000.4481.67(%)(%)Batch-1n666666–Av.8.927.8144876120.4001.70–Precision (%)4.1 %3.5 %2.0 %0.8 %1.4 %2.7 %–Accuracy (%)89.5 %92.5 %96.5 %95.1 %89.4 %101.6 %–Batch-2n666666–Av.9.729.4146877560.3891.54–Precision (%)2.6 %2.3 %1.0 %1.7 %1.6 %1.9 %–Accuracy (%)97.3 %98.1 %97.9 %96.9 %86.8 %91.9 %–Batch-3n66666611Av.9.127.3147976010.3851.60–Precision (%)5.9 %1.5 %2.1 %0.5 %2.5 %1.6 %–Accuracy (%)91.4 %91.0 %98.6 %95.0 %86.0 %95.8 %96.887.8QC sample Inter-Batch Statsn181818181818–Av.9.2728.2146576560.3921.61–Precision (%)5.5 %4.1 %1.9 %1.4 %2.4 %4.7 %–Accuracy (%)92.7 %93.9 %97.7 %95.7 %87.4 %96.4 %– QC SampleQC-LLOQ(ng/mL)QC-1(ng/mL)QC-2(ng/mL)QC-3(ng/mL)HempCRM(mg/g)Cannabis CRM(mg/g)HEMPRRSRecoveryCannabisRRSRecovery1030150080000.01430.303(%)(%)Batch-1n666666–Av.8.728.1148873710.01160.224–Precision (%)2.6 %2.3 %1.1 %0.5 %4.9 %0.8 %–Accuracy (%)86.6 %93.5 %99.2 %92.1 %81.0 %88.7 %–Batch-2n666666–Av.9.329.1154875790.01170.213–Precision (%)4.2 %1.3 %1.2 %1.1 %5.4 %1.0 %–Accuracy (%)92.9 %96.8 %103.2 %94.7 %81.9 %84.5 %–Batch-3n66666611Av.9.427.7152373390.01190.211–Precision (%)4.4 %2.4 %0.7 %0.6 %4.3 %0.5 %–Accuracy (%)94.0 %92.5 %101.5 %91.7 %83.5 %83.8 %99.1104.1QC sample Inter-Batch Statsn181818181818–Av.9.1228.3152074300.01170.216–Precision (%)5.2 %2.8 %1.9 %1.7 %4.8 %2.7 %–Accuracy (%)91.2 %94.3 %101.3 %92.9 %82.1 %85.7 %– QC SampleQC-LLOQ(ng/mL)QC-1(ng/mL)QC-2(ng/mL)QC-3(ng/mL)HempCRM(mg/g)Cannabis CRM(mg/g)HEMPRRSRecoveryCannabisRRSRecovery1030150080000.07280.446(%)(%)Batch-1n666666–Av.8.727.5146774550.06860.423–Precision (%)1.2 %1.5 %0.6 %0.7 %1.6 %1.0 %–Accuracy (%)86.9 %91.6 %97.8 %93.2 %94.2 %94.7 %–Batch-2n666666–Av.9.228.9152175690.06750.405–Precision (%)2.9 %1.4 %0.9 %0.7 %1.9 %1.6 %–Accuracy (%)91.8 %96.2 %101.4 %94.6 %92.7 %90.7 %–Batch-3n66666611Av.9.227.8153573630.06950.411–Precision (%)1.9 %1.1 %0.6 %0.6 %1.7 %0.7 %–Accuracy (%)91.6 %92.8 %102.3 %92.0 %95.4 %92.1 %101.1102.5QC sample Inter-Batch Statsn181818181818–Av.9.0128.1150874620.06850.413–Precision (%)3.3 %2.5 %2.1 %1.3 %2.0 %2.2 %–Accuracy (%)90.1 %93.5 %100.5 %93.3 %94.1 %92.5 %– QC SampleQC-LLOQ(ng/mL)QC-1 (ng/mL)QC-2(ng/mL)QC-3(ng/mL)HempCRM(mg/g)Cannabis CRM(mg/g)HEMPRRSRecoveryCannabisRRSRecovery1030150080000.1880.0415(%)(%)Batch-1n666666–Av.9.028.0147476480.1750.0389–Precision (%)3.0 %2.6 %1.5 %1.7 %1.9 %3.6 %–Accuracy (%)90.3 %93.5 %98.3 %95.6 %93.4 %93.7 %–Batch-2n666666–Av.9.228.8151777320.1700.0372–Precision (%)2.7 %2.0 %1.5 %0.9 %1.1 %2.7 %–Accuracy (%)92.3 %95.9 %101.1 %96.7 %90.2 %89.6 %–Batch-3n66666611Av.9.327.9152073610.1690.0368–Precision (%)3.9 %2.4 %0.6 %1.4 %0.9 %2.1 %–Accuracy (%)93.3 %93.0 %101.3 %92.0 %89.9 %88.7 %96.798.6QC sample Inter-Batch Statsn181818181818–Av.9.2028.2150475800.1710.04–Precision (%)3.4 %2.6 %1.8 %2.5 %2.2 %3.7 %–Accuracy (%)92.0 %94.1 %100.2 %94.8 %91.2 %90.7 %– QC SampleQC-LLOQ(ng/mL)QC-1(ng/mL)QC-2(ng/mL)QC-3(ng/mL)HempCRM(mg/g)Cannabis CRM(mg/g)HEMPRRSRecoveryCannabisRRSRecovery1030150080000.7190.126(%)(%)Batch-1n666666–Av.8.827.5145375600.7140.111–Precision (%)2.1 %1.0 %1.6 %1.8 %1.8 %2.6 %–Accuracy (%)88.1 %91.5 %96.9 %94.5 %99.2 %88.3 %–Batch-2n666666–Av.9.128.5150376660.6950.108–Precision (%)2.1 %1.2 %1.3 %1.0 %0.7 %5.6 %–Accuracy (%)90.6 %94.9 %100.2 %95.8 %96.7 %86.1 %–Batch-3n66666611Av.9.228.1153474220.7110.112–Precision (%)2.0 %1.1 %1.2 %1.2 %2.1 %0.9 %–Accuracy (%)92.3 %93.5 %102.3 %92.8 %98.9 %88.6 %104.2100.0QC sample Inter-Batch Statsn181818181818–Av.9.0328.0149775490.7070.110–Precision (%)2.8 %1.8 %2.6 %1.9 %2.0 %3.6 %–Accuracy (%)90.3 %93.3 %99.8 %94.4 %98.3 %87.7 %– QC SampleQC-LLOQ(ng/mL)QC-1(ng/mL)QC-2(ng/mL)QC-3(ng/mL)HempCRM(mg/g)CannabisCRM(mg/g)HEMPRRSRecoveryCannabisRRSRecovery1030150080000.0741-(%)(%)Batch-1n66666—Av.8.627.5146075310.0662—Precision (%)1.3 %1.4 %0.7 %0.7 %0.7 %—Accuracy (%)86.0 %91.8 %97.3 %94.1 %89.3 %—Batch-2n66666—Av.8.928.9151576480.0638—Precision (%)1.9 %1.1 %0.6 %0.7 %1.1 %—Accuracy (%)89.0 %96.3 %101.0 %95.6 %86.1 %—Batch-3n66666-11Av.9.027.2149074230.0637—Precision (%)1.7 %1.1 %0.6 %0.6 %0.8 %—Accuracy (%)90.2 %90.7 %99.3 %92.8 %86.0 %-96.894.7QC sample Inter-Batch Statsn1818181818—Av.8.8427.9148875340.0646—Precision (%)2.6 %2.9 %1.6 %1.4 %2.0 %—Accuracy (%)88.4 %92.9 %99.2 %94.2 %87.1 %— QC SampleQC-LLOQ(ng/mL)QC-1(ng/mL)QC-2(ng/mL)QC-3(ng/mL)HempCRM(mg/g)CannabisCRM(mg/g)HEMPRRSRecoveryCannabisRRSRecovery1030150080000.187-(%)(%)Batch-1n66666—Av.8.627.6150877680.205—Precision (%)2.7 %2.5 %3.7 %3.2 %1.6 %—Accuracy (%)86.4 %92.1 %100.5 %97.1 %109.7 %—Batch-2n66666—Av.9.629.4150177150.193—Precision (%)2.3 %1.0 %1.6 %0.6 %1.3 %—Accuracy (%)95.9 %97.9 %100.0 %96.4 %103.1 %—Batch-3n66666-11Av.9.227.4151473690.197—Precision (%)3.3 %2.6 %2.4 %1.7 %1.9 %—Accuracy (%)92.4 %91.4 %100.9 %92.1 %105.4 %-101.291.3QC sample Inter-Batch Statsn1818181818—Av.9.1628.1150876170.198—Precision (%)5.1 %3.7 %2.6 %3.1 %3.1 %—Accuracy (%)91.6 %93.8 %100.5 %95.2 %106.1 %— QC SampleQC-LLOQ(ng/mL)QC-1(ng/mL)QC-2(ng/mL)QC-3(ng/mL)HempCRM(mg/g)CannabisCRM(mg/g)HEMPRRSRecoveryCannabisRRSRecovery103015008000–(%)(%)Batch-1n6666—-Av.8.727.914677500—-Precision (%)1.5 %1.5 %0.8 %0.6 %—-Accuracy (%)87.5 %93.0 %97.8 %93.8 %—-Batch-2n6666—-Av.9.229.315247667—-Precision (%)2.4 %0.8 %0.7 %0.7 %—-Accuracy (%)92.2 %97.7 %101.6 %95.8 %—-Batch-3n6666–11Av.9.127.414947465—-Precision (%)2.3 %0.9 %0.3 %0.6 %—-Accuracy (%)91.0 %91.5 %99.6 %93.3 %–98.195.7QC sample Inter-Batch Statsn18181818—-Av.9.0228.214957544—-Precision (%)3.0 %3.1 %1.7 %1.3 %—-Accuracy (%)90.2 %94.1 %99.7 %94.3 %—- IDTHCTHCACBDCBDACBGCBGACBNCBNACBCCBCATHCVTHCVACBDVCBDVACBLCBLAConc (mg/g)16.2651.44.3793.20.7213.150.1230.8450.4225.250.0510.4070.0200.428<0.0020.00914Repeatability (%)9.27.68.98.87.19.86.55.53.99.86.27.81.86.7N/AP7.8Int Precision (%)7.16.18.5 5.97.17.85.64.3 5.06.95.3 6.56.86.5N/AP8.0Conc (mg/g)226.926.018.167.60.4741.800.020.7621.464.080.2040.2100.07000.2820.00210.0218Repeatability (%)3.64.63.64.03.54.35.13.64.94.54.93.36.24.18.510.0Int Precision (%)4.43.94.0 3.74.24.14.25.2 5.75.94.6 3.74.94.510.09.3Conc (mg/g)36.921240.0100.2750.7262.180.1552.360.0920.9730.0340.569<0.0020.0024<0.002<0.002Repeatability (%)3.44.74.45.44.05.34.54.62.010.33.12.6N/AP5.4N/APN/APInt Precision (%)6.15.98.1 7.67.48.011.07.4 8.810.78.0 6.8N/AP11.9N/APN/APConc (mg/g)45.271660.007360.3611.053.830.0200.5150.1593.040.01330.279<0.002<0.002<0.002<0.002Repeatability (%)3.12.18.82.81.72.21.52.62.95.112.43.8N/APN/APN/APN/APInt Precision (%)8.98.112.8 6.57.28.17.48.7 5.57.011.0 7.1N/APN/APN/APN/APConc (mg/g)50.9174.899.261410.3911.290.0240.06430.6786.490.01030.05760.08301.38<0.002<0.002Repeatability (%)6.54.05.66.34.77.51.27.07.77.05.82.21.95.9N/APN/APInt Precision (%)5.23.85.5 4.43.85.43.65.1 5.45.54.4 2.23.64.8N/APN/APConc (mg/g)60.8035.169.311510.6362.530.0350.1130.7557.910.002670.01570.02260.3620.00790.0655Repeatability (%)2.63.23.41.63.63.13.94.52.75.45.63.35.24.43.63.7Int Precision (%)4.64.55.73.84.34.84.24.2 4.95.28.2 8.85.64.33.710.8Conc (mg/g)76.6913.90.008670.04620.0630.3800.1290.2510.2840.5510.04360.104<0.002<0.002<0.002<0.002Repeatability (%)4.84.86.88.15.34.67.67.23.97.86.06.1N/APN/APN/APN/APInt Precision (%)5.54.98.76.34.35.44.66.34.45.84.84.7N/APN/APN/APN/AP ;

ICS Code

ICS Number Code 11.120.99 (Other standards related to pharmaceutics)

DOI: 10.1520/D8375-23

Additional information

Standard Title	D8375-23 Standard Test Method for Determination of Cannabinoid Concentration in Dried Cannabis and Hemp Raw Materials using Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)
Published Code	ASTM
Publication Date	2023
Pages Count	17
ICS Codes	11.120.99 - Other standards related to pharmaceutics