Specification sheet (version: November 2014)
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1 sheet (version: November 2014) Product: Cannabis flos, ssp. sativa, variety Bedrocan (hemp flowers) Market: to be sold on the pharmaceutical market Strength: dronabinol: approx. 22% cannabidiol: <1.0% Dosage form: flowers Package size: 5 grams in containers, 250 grams in bags Appearance Brown green clustered flowers of 1,5 to 3 cm with a characteristic smeil Identity microscopy Mainly gland hairs visible thin layer chromatography Foreign material Staiks, insects and other vermin are absent Fineness no leaves shooting out more then 20% of the length of the flowers stalks are cut away directly under the bottom flowers of the inflorescence Absence of Ph. Eur (current ed.) pesticides Microbiological Ph. Eur (current ed.) purity Total aerobic < 102 cfu/gram microbial count (TAMC) Total yeast and cfu/gram moulds count (TYMC) 1 Analytical monograph by BMC / Farmalyse, version 7.1 of November, 2014
2 P. aeruginosa, S Absent aureus and Bile tolerant gram neg bacteria Absence of heavy m eta Is lead Ph. Eur (current ed.) max ppm mercury Heavy metals in herbal max. 0.5 ppm cadmium drugs and fatty oils max. 0.5 ppm arsenic(indicative) (monograph) - nickel (indicative) - zinc (indicative) - Absence of Ph. Eur (current ed.) <4 pg/kg aflatoxines Determination of aflatoxins B1, B2, G1 and G2 in herbal drugs (2.8.18) Loss on drying Ph. Eur (current ed.) 10.0 % Loss on drying meth. C (2.2.32) Assay (UPLC) fingerprint similar dronabinol (THC) approx. 22 % cannabidiol(cbd) <1.0 h Related substances (U PLC) cannabinol(cbn) <1.0 %
3 sheet (version: November 2014) Product: Cannabis flos, ssp. sativa, variety Bedrobinol (hemp flowers) Market: to be sold on the pharmaceutical market Strength: dronabinol: approx. 13.5% cannabidiol: <1.0% Dosage form: flowers Package size: 5 grams in containers Appearance Identity 2 Brown green clustered flowers of 1,5 to 3 cm with a characteristic smell microscopy Mainly gland hairs visible thin layer chromatography Foreign material Stalks, insects and other vermin are absent Fineness no leaves shooting out more then 20% of the length of the flowers stalks are cut away directly under the bottom flowers of the inflorescence Absence of Ph. Eur (current ed.) pesticides Microbiological Ph. Eur (current ed.) purity Total aerobic cfu/gram microbial count (TAMC) Total yeast and locfu/gram moulds count (TYMC) 2 Analytical monograph by BMC / Farmalyse, version 7.1 of November, 2014
4 P. aeruginosa, Absent S. aureus and Bile tolerant gram neg bacteria Absence of heavy metals lead Ph. Eur (current ed.) max ppm mercury Heavy metals in herbal max. 0.5 ppm cadmium drugs and fatty oils max. 0.5 ppm arsenic (indicative) (mc nog ra ph) - nickel (indicative) ninc (indicative) Absence of Ph. Eur (current ed.) <4 pg/kg aflatoxines Determination of aflatoxins B1, B2, G1 and G2 in herbal drugs (2.8.18) Loss on drying Ph. Eur (current ed.) 10.0 % Loss on drying meth. C (2.2.32) Assay (UPLC) fingerprint Similar dronabinol (THC) approx % cannabidiol(cbd) <1.0 % Related substances (U PLC) cannabinol(cbn) <1.0 %
5 sheet (version: November 2014) Product: Cannabis flos, ssp. sativa, variety Bediol (hemp flowers) Market: to be sold on the pharmaceutical market Strength: dronabinol: approx. 6.3% cannabidiol: approx. 8% Dosage form:flowers, granulated Package size: 5 grams in containers, 50 grams in bags Appearance Identity 3 Brown green granulated material of the flowers (about S mm) with a characteristic smell microscopy Mainly gland hairs visible thin layer chromatography Foreign material Insects and other vermin are absent Fineness Stalks are not longer than 2.0 cm Only 20% of the stalks is between 1.5 and 2.0 cm Absence of Ph. Eur (current ed.) pesticides Microbiological Ph. Eur (current ed.) purity Total aerobic cfu/gram microbial count (TA4C) Total yeast and l0cfu/gram moulds count (TYMC) P. aeruginosa, Absent S. aureus and Bile tolerant gram neg bacteria Analytical monograph by BMC / Farmalyse, version 7.1 of November, 2014
6 Absence of heavy metals lead Ph. Eur (current ed.) max ppm mercury Heavy metals in herbal max. 0.5 ppm cadmium drugs and fatty oils max. 0.5 ppm arsenic (indicative) (monograph) - nickel (indicative) - zinc (indicative) - Absence of Ph. Eur (current ed.) <4 pg/kg aflatoxines Determination of aflatoxins B1, B2, G1 and G2 in herbal drugs (2.8.18) Loss on drying Ph. Eur (current ed.) S 10.0 % Loss on drying meth. C (2.2.32) Assay (UPLC) fingerprint Similar dronabinol (THC) cannabidiol (CBD) approx. 6.3 % approx. 8 % Related substances (U PLC) cannabinol(cbn) <1.0 %
7 sheet (version: November 2014) Product: Cannabis flos, ssp. indica, variety Bedica (hemp flowers) Market: to be sold on the pharmaceutical market Strength: dronabinol: approx. l4% cannabidiol: <1.0% Dosage form:flowers, granulated Package size: 5 grams in containers Appearance Id entity 4 Brown green granulated material of the flowers (about 5 mm) with a characteristic smell microscopy Mainly gland hairs visible thin layer chromatography Foreign material Insects and other vermin are absent Fineness Stalks are not longer than 2.0 cm Only 20% of the staiks is between 1.5 and 2.0 cm Absence of Ph. Eur (current ed.) pesticides Microbiological Ph. Eur (current ed.) purity Total aerobic cfu/gram microbial count (TAMC) Total yeast and cfu/gram moulds count (TYMC) P. aeruginosa, Absent S. aureus and 811e tolerant gram neg bacteria Analytical monograph by BMC / Farmalyse, version 7.1 of November, 2014
8 Absence of heavy m eta Is lead Ph. Eur (current ed.) max ppm mercury Heavy metals in herbal max. 0.5 ppm cadmium drugs and fatty oils max. 0.5 ppm arsenic (indicative) (monograph) nickel (indicative) zinc (indicative) Absence of Ph. Eur (current ed.) <4 pg/kg aflatoxines Determination of aflatoxins B1, B2, G1 and G2 in herbal drugs (2.8.18) Loss on drying Ph. Eur (current ed.) 10.0 k Loss on drying meth. C (2.2.32) Assay (UPLC) fingerprint similar dronabinol(thc) cannabidiol(cbd) approx. 14 h <1.0 % Related substances (UPLC) cannabinol(cbn) <1.0 %
9 sheet (version: November 2014) Product: Cannabis flos, ssp. sativa, variety Bedrolite (hemp flowers) Market: to be sold on the pharmaceutical market Strength: dronabinol: < 1.0% cannabidiol: approx. 9.0 h Dosage form:flowers, granulated Package size: 5 grams in containers Appearance Id entity 5 Brown green granulated material of the flowers (about 5 mm) with a characteristic smeil microscopy Mainly gland hairs visible thin layer chromatography Foreign material Insects and other vermin are absent Fineness Stalks are not longer than 2.0 cm Only 20% of the stalks is between 1.5 and 2.0 cm Absence of Ph. Eur (current ed.) pesticides Microbiological Ph. Eur (current ed.) purity Total aerobic <102 cfu/gram microbial count (TAMC) Total yeast and cfu/gram moulds count (TYMC) P. aeruginosa, S Absent aureus and Bile tolerant gram neg bacteria Analytical monograph by BMC / Farmalyse, version 7.1 of November, 2014
10 Absence of heavy metals lead Ph. Eur (current ed.) max ppm mercury Heavy metals in herbal max. 0.5 ppm cadmium drugs and fatty oils max. 0.5 ppm arsenic (indicative) (monograph) - nickel (indicative) zinc (indicative) Absence of Ph. Eur (current ed.) <4 pg/kg aflatoxines Determination of aflatoxins B1, B2, G1 and G2 in herba drugs (2.8.18) Loss on drying Ph. Eur (current ed.) 10.0 % Loss on drying meth. C (2.2.32) Assay (UPLC) fingerprint similar dronabinol (THC) cannabidiol (CBD) < i.o % approx. 9.0 % Related substances (U PLC) cannabinol(cbn) <1.0 %
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