HA-DOTATATE GMP

HA-DOTATATE GMP Grade

Product name: HA-DOTATATE (Acetate salt)

Precursor for radiometal-labelled HA-DOTATATE

High Affinity DOTATATE for imaging & therapy

Molecular Weight: 1561.5 [g/mol]

Molecular Formula: C65H89IN14O19S2

HA-DOTATATE (GMP Grade)

General Information

Product no.: 50001
Product name: HA-DOTATATE (Acetate salt)
Synonyms: High-affinity DOTATATE,
DOTA-3-iodo-Tyr3-octreotate
Sequence: DOTA-dPhe-Cys-Tyr(3-Iodo)-dTrp-Lys-Thr-Cys-Thr
Molecular weight: 1561.5 [g/mol]
Molecular formula: C65H89IN14O19S2
CAS no.:  n.a.


Product description

Labelling precursor for [68Ga] or [177Lu].
For use by qualified personnel only.

Quantity

Product no. 50001: 250 µg net peptide (lyophilisate, acetate salt)

Packaging

Clear tubular glass vials type I (borosilicate, 2 mL) with lyophilisation stoppers and closed with aluminium caps.

Storage and Stability

Storage at -20°C (± 5°C). Protect from light.
A temperature increase up to +25ºC (± 2ºC) over a period of 14 days does not affect the purity of the chemical precursor.

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).