
HA-DOTATATE GMP Grade
Precursor for radiometal-labelled HA-DOTATATE
High-affinity DOTATATE for imaging & therapy
Molecular Weight: 1561.5 (av.)
Molecular Formula: C65H89IN14O19S2
HA-DOTATATE (GMP Grade)
General Information
Product name: HA-DOTATATE (acetate salt)
Synonyms: High-affinity DOTATATE, DOTA-3-iodo-Tyr3-octreotate
Sequence: DOTA-dPhe-Cys-Tyr(3-iodo)-dTrp-
Molecular Weight: 1560.5 (m.i.), 1561.5 (av.)
Molecular Formula: C65H89IN14O19S2
Product description
Labelling precursor for 68Ga-, 177Lu- and other M3+ [1-3].
For use by qualified personnel only.
Quantity
Product No. 50000: 50 µg net peptide (lyophilisate, acetate salt)
Product No. 50001: 250 µg net peptide (lyophilisate, acetate salt)
Packaging
2 mL ISO clear type I tubular glass vials (2R borosilicate clear glass vials type I);
13mm crimp neck;
Lyophilisation stoppers;
Flip-off seal.
Storage and Stability
Storage at -20°C (± 5 °C). Protect from light.
Short-term temperature excursion to +25ºC (± 2ºC) over a period of 14 days for HA-DOTATATE 250 µg (Product No. 50001) does not affect the purity of the chemical precursor. HA-DOTATATE 50 µg (Product No 50000) is stable for 4 days at +25°C (± 2ºC).
Certificates
Certificate of Analysis
Certificate of Compliance
TSE/BSE Statement on request
Manufactured in full compliance with current GMP requirements. Specifications according to Ph. Eur. 2902 “Chemical precursors for radiopharmaceutical preparations”.
Literature
[1] Schottelius M. et al. Twins in spirit – episode I: comparative preclinical evaluation of [(68)Ga]DOTATATE and [(68)Ga]HA-DOTATATE. EJNMMI Res, 2015, 5:22.
[2] Hartmann H. et al. Dosimetric measurements of (68)Ga-high affinity DOTATATE: twins in spirit – part III. Nuklearmedizin, 2014, 53(5):211-6.
[3] Brogsitter C. et al. Twins in spirit part IV – [ 177 Lu] high affinity DOTATATE. A promising new tracer for peptide receptor radiotherapy? Nuklearmedizin, 2017, 56(1):1-8.
[4] Braat AJ et al. Gastrointestinal stromal tumour detection with somatostatin receptor imaging, 68Ga-HA-DOTATATE PET-CT. Lancet Oncol., 2017, 18(3).