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Table 1 Pre-set acceptance criteria of [68Ga]Ga-DOTA-CP04 injection and the observed results

From: Automated preparation of clinical grade [68Ga]Ga-DOTA-CP04, a cholecystokinin-2 receptor agonist, using iPHASE MultiSyn synthesis platform

+Parameter

Specification

[68Ga]Ga-DOTA-CP04

Appearance

Clear and colorless

Pass

pH

4–8

5–6

Radionuclidic identity (half-life)

62–74 min

Pass

Radiochemical identity (HPLC)

Reference standard ±1.0 min

Pass

Radiochemical Purity (HPLC)

≥ 90% [68Ga]Ga-DOTA-CP04

<  8% oxidized material

92–94%

4–6%

Radiochemical Purity (TLC)

≥ 98%

≤ 2% free Ga-68

>  98%

<  2%

Ethanol content

≤10%

9–10%

Bubbling point test

≥ 55 psi

Pass

Sterility

Sterile

No growth

Endotoxin

<  175 IU per dose

< 5 IU per dose