Release certificate

Ministry of Health, Welfare and Sport
Office of Medicinal Cannabis
Release certificate
Product:
Country:
Strength:
Dosage form:
Package size:
Batch:
Order numbers:
Grower/drier:
Gamma irradiation:
Packager:
Part of analysis:
Laboratories:
Analysis number:
Report date:
Testing method:
End check:
Cannabis flos, variety Bedrocari (hemp flowers)
to be sold on the pharmaceutical market
dronabinol: approx. 22%
cannabidiol : <1.0%
flowers
5 grams in container
14G21 EY14HO5
containers: 296821 to 296832
Bedrocan BV
harvest date/period:
P0. Box 2009
21 July 2014
NL- 9640 CA Veendam
Synergy Health
date:
dose:
Soevereinstraat 2
5 August 2014
10,0 kGy
NL-4879 NN Etten-Leur
Fagron BV
date:
Venkelbaan 101
8—12 September 2014
NL-2908 KE Capelle a/d IJssel
1 .general analysis
2.microbiology of end product in
container
1.
Farmalyse BV
2.
Bactimm BV
Pieter Lieftinckweg 2
Middenkampweg 17
NL-1 505 HX Zaandam
NL-6545 CH Nijmegen
1.394-1408-1045
2. 15.592
1. 18September2014
2.22 September2014
Analytical monograph by BMC / Farmalyse, version 7.0, Oct. 31, 2013
Office of Medicinal Cannabis
date: 17September2014
Appearance
Identity
microscopy
thin Iayer
chroma tography
Foreign material
Fineness
P0. Box 16114
NL-2500 BC THE HAGUE
The Netherlands
Telephone +31 703405113
Telefax +31 70 340 7426
Method
monograph
Specification
brown green clustered flowers
of 1,5 to 3cm with a
characteristic smeli
Result
conform
monograph
monograph
mainly gland hairs visible
monograph
conform
conform
mo nog raph
staiks, insects and other
vermin are absent
• no leaves shooting out
more then 20% of the
length of the flowers
• staiks are cut away directly
under the bottom flowers of
the infiorescence
conform
monograph
Address:
Wijnhaven 16
NL-251 1 GA THE HAGUE
The Netherlands
All correspondence
addressed to the postal
address quoting date and
reference of this letter.
conform
Internet address:
www.minvws.nl
www.cannabisoffice.nl
e-mail:
[email protected]
Ministry of Health, Welfare and Sport
Office of Medicinal Cannabis
Page
2
Our reference
1 4G21 EY1 4H05
Microbiological purity
Totalaerobicmicrobial
count (TAMC)
Totalyeastandmoulds
count (TYMC)
P. aeruginosa,
S.aureus and 811e
tolerant gram neg
bacteria
Absence of aflatoxines
Absence of pesticides
Absence of heavy metal
bad
mercury
cadmium
Loss on drying
Assay (UPLC)
fingerprint
dronabinol(THC)
cannabidiol(CBD)
Related substances
(UPLC)
cannabinol(CBN)
Content of container
Expirydate
Method
Ph. Eur (current ed.)
5.1.4.
5.1.4-1.
cfu/gram
2
lO
<10 cfu/gram
5.1.4-1.
locfu/gram
<10 cfu/gram
Specification
Result
5.1.4-1.
absent
Ph.Eur (current ed.)
“Determination of
aflatoxins B
,B
1
,G
2
1
and G
2 in herbal
drugs” (2.8.18)
monograph
conform
<4 .iglkg
<2.2 ig/kg
Ph. Eur (current ed.) 2.8.13
Ph. Eur (current ed.)
“Heavy metals in
herbal drugs and
fatty oils”
(monograph)
Ph. Eur (current ed.)
“Loss on drying”
meth. C (2.2.32)
max. 20.0 ppm
max. 0.5 ppm
max. 0.5 ppm
monograph
monograph
monograph
similar
approx. 22 %
<1.0 %
monograph
BMC-SWV 320
conform
<1.0 ppm
<0.1 ppm
<0.1 ppm
10.0 %
<1.0 %
approx. 5 gram
9.9 %
conform
22.1 %
0.1 %
±
0.1 %
5.04 gram
08! 2015
1 hereby certify that the above information is authentic and accurate. This batch of product has been
cultivated and manufactured, inciuding packaging and quality control at the above mentioned sites in full
compliance with the GAF requirements as published in the Dutch State Gazette (Staatscourant) as the
annex to the Regulation of the Minister of Health, Welfare and Sport of 9 January 2003, GMT/BMC
2340685, and with the specifications as stated in this document. The batch processing, packaging and
analysis records were reviewed and found to be in compliance with GAF and GMP.
TheHague, the Netherlands, 22 September 2014
J
Dr. M.J. van de V&de
head, Officè of Medicinal Cannabis

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