HA-DOTATATE GMP

HA-DOTATATE GMP Grade

Product name: HA-DOTATATE (acetate salt)

High-affinity DOTATATE, DOTA-3-iodo-Tyr3-octreotate

Molecular Weight: 1560.5 (m.i.)

Molecular Formula: C65H89IN14O19S2

HA-DOTATATE

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 (cyclo Cys 2-7)
Molecular Weight: 1560.5 (m.i.), 1561.5 (av.)
Molecular Formula:  C65H89IN14O19S2

Applications

Labelling precursor for 68Ga-, 177Lu- and other M3+ labeled
HA-DOTATATE [1-3].

Quantity and Packaging

Product No. 50000 – 50 µg net peptide
Product No. 50001 – 250 µg net peptide

2 mL ISO clear type I tubular glass vials with 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

Manufactured in full compliance with current GMP requirements. Specifications according to Pharm. 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.

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