Article Figures & Data
Figures
- FIGURE 1.
Structural formula of 68Ga-PSMA-11.
- FIGURE 2.
68Ga-PSMA-11 production method from UCLA NDA 212642.
- FIGURE 3.
68Ga-PSMA-11 production method (cyclotron-based) from UCSF NDA 212643.
- FIGURE 4.
68Ga-PSMA-11 production method (generator-based) from UCSF NDA 212643.
Tables
Criteria Acceptance Specific filling Amount of filling 1 mg ± 10% Identity (HPLC) Reference retention time ± 0.5 min Impurities (HPLC) Any unspecified impurity ≤ 2.0% Total impurities ≤ 6.0% Bioburden/vial TAMC ≤ 100 cfu TYMC ≤ 10 cfu BET (LAL) ≤ 10 IU/vial Bulk precursor batch Appearance White to off-white solid Monoisotopic mass (net peptide) 946.1 ± 1 m.u. 1H-NMR Conforms to structure 13C-NMR Conforms to structure Impurities (HPLC) Any unspecified impurity ≤ 2.0% Total impurities ≤ 3.0% Residual solvents (GC) Acetonitrile ≤ 5,000 ppm Tertbutylmethylether ≤ 5,000 ppm Water (GC) ≤ 10% Heavy metals (ICP-MS) Iron ≤ 100 ppm; Copper ≤ 100 ppm; Zinc ≤ 100 ppm; Palladium ≤ 100 ppm Assay (HPLC) ≥50% Trifluoroacetic acid (GC) ≤40% HPLC = high performance liquid chromatography; TAMC = total anaerobic microbial count; TYMC = total yeast/mold count; BET = bacterial endotoxin test; LAL = limulus amebocyte lysate; NMR = nuclear MR; GC = gas chromatography; ICP-MS = inductively coupled plasma mass spectrometry.
Component Amount Function Quality standard 68Ga-PSMA-11 18.5–185 MBq/mL (0.5–5 mCi/mL) Drug substance In-house PSMA-11 5 μg Drug substance precursor GMP HEPES* 1.5 mL (1.5 M) Processing aid PharmaGrade Hydrochloric acid*1 5 mL (0.1 M) Processing aid GMP Sodium chloride 0.9% injection 10 mL Tonicity USP Ethanol 1 mL Eluent USP Water for injection USP 1 mL Eluent USP ↵* HEPES and hydrochloric acid are completely removed during processing and are not present in final formulation. GMP = good manufacturing practice; HEPES = 4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid.
Component Amount Function Quality standard PSMA-11 5 μg Precursor GMP grade 68Ga-PSMA-11 18.5–185 MBq/mL (0.5–5 mCi/mL) Drug substance In-house Sodium acetate, 1 M* 1.3 mL Buffering agent Pharma grade Nitric acid, 0.1 M1 4 mL 68Ga purification Trace-metal basis Hydrochloric acid, 1.75 M* 4 mL 68Ga purification Ultrapure Sodium chloride, 2 M1 4 mL 68Ga purification Trace metal basis Ethanol, 60% 1 mL Product eluent USP grade Ultra-high purity water 50 mL Solution preparation Pharma grade Water for injection 100 mL Solution preparation USP grade Sodium chloride, 0.9% 5–10 mL Isotonicity USP grade ↵* Completely removed during processing and are not present in final formulation. GMP = good manufacturing practice.
Component Amount Function Quality standard PSMA-11 5 μg Precursor GMP grade 68Ga-PSMA-11 18.5–185 MBq/mL (0.5–5 mCi/mL) Drug substance In-house Sodium acetate, 0.5 M* 0.1 mL Buffering agent Pharma grade Hydrochloric acid, 0.1 M* 5 mL Generator eluent GMP grade Ethanol, 60% 1 mL Product eluent USP grade Ultra-high purity water 10 mL Solution preparation Pharma grade Water for injection 4 mL Solution preparation USP grade Sodium chloride, 0.9% 5–10 mL Isotonicity USP grade ↵* Completely removed during processing and are not present in final formulation. GMP = good manufacturing practice.
Test Test method Acceptance criteria Prerelease Radiochemical purity Thin-layer chromatography ≥90% Appearance Visual observation Clear solution, free of particulates pH pH paper 4.0–7.0 Endotoxin content PTS Endosafe, USP < 85 > <17.5 EU/mL Radiochemical identity Thin layer chromatography* UCLA: Rf value = 0.75–0.95 UCLA: Rf value = 0.3–0.6 Radionuclidic identity Half-life determination 64.4–71.2 min Filter integrity Bubble point pressure reading, USP < 823 > / < 797 > >50 psi Postrelease Sterility Direct inoculation. USP < 71 > / < 823 > Sterile ↵* UCLA and UCSF use different mobile phases.
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