CUMIUMW
Date : 10 Jun 2023 LIFE FORWARD
page 2
RELEASE CERTIFICATE
TEKCIS TCIK
REFERENCE, 2 TEKCIS Batch Number TOK
PRODUCT. TECHNETIUM (99nTc] STERILE GENERATOR Manufacturing Date: 10 Jun 2023
Expiry Date gu 2023
Specification : MA-00242
Appearance of solution Clear and colorless solution, absence Compliant
of visible particules
Radionuclidic identification 140 kev Compliant
Aluniniun content Maximan 5 ppm =<5 ppo
pH 4.5 007.5 69
Radiochenical purity Minimum 95 & 59%
Radionuclidic purity (at expizy date) Maximum 0.2% 0.0897 &
99Mo content
99M activity 90-2208 of nominal activity compliant
sone activity 30-110% of nominal activity compliant
(by calculation)
Nitrate content iby nitrate paper strip) < 137 jig/ml compliant
Bacterial endotoxins tess than 11 TU/ml In Progress
(IAL test)
Sterility (by direct Sterile in 16 days In Progress
inoculation)
99Mo content, by Gamma spectronery Maximum 0.2. In Progress
2517 content Maximum 5 10-38 In Progress
1038 content, Maximum 5 10-38 In Progress
88Sr content Maximum 6 10-5 % In Progress
908r content Noximim 6 10-6 In Progress
Ripha-emitting impuricies Maximum 1 10-7 & In Progress
1S ba international | SAS au capital de38 708 OS0Euro8 | Sige socal Saclay (Essonne | RN 306 | BP 22 | 93192 Gitsurhvete | Caden France
Tel +33 16985 7072 RCS ForyB 312 261 894 Nidenfcation TVA FR 46 332 263 894
Member of Cunum group
Weunampharma com —CULIUM
Date : 10 dun 2023 LIFE FORWARD
page 2
RELEASE CERTIFICATE
TEKCIS TOK
norms RESULTS
Garma-eniteing impurities Maximum 0.01 % (1 10-2 %) In Progress
REFERENCE : TEKCIS , Lor : TOK
This confirms that the above product was manufactured in accordance with approved procedures,
master production documents and current Good Manufacturing Practises and meets regulatory requirements
ALL documentation has been reviewed and found to be in compliance with the master production docunents
and product specifications
etch stacus ; CEEGAHD) -ausorep_
Date + 20 dun 2025
‘Sto iternatona | SAS av capt de 38708 O50 Furos | Sibge sooal- Saclay (Essonne} | RN 306 BP 12 91392 Gi sur Yete | Cedex Fra
Tel 633 168985 7072 RCS Evry 8312 261 896 | N"idencabon TVA FR 46 312 261 894
wembee of Corum group