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 (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-Lys-Thr-Cys-Thr
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).