Skip to main content

Table 2 Examples of drug substances, drug products and starting materials

From: Position paper to facilitate patient access to radiopharmaceuticals: considerations for a suitable pharmaceutical regulatory framework

Drug Substance / Abbrev

Drug Product

Starting materials / precursors

Radioactive

Non-radioactive

[99mTc]Tc-3,3-diphosphono-1,2-propanodicarboxylic acid ([99mTc]Tc-DPD)

Aqueous solution of [99mTc]Tc-DPD, SnCl2, buffer, + other excipients

Sodium 99mTc- pertechnetate (Na[99mTc]TcO4)

3,3-Diphosphono-1,2-propanodicarboxylic acid (DPD)

[18F]F-amino-3-[4-(2-fluoroethoxy)phenyl]propanoic acid ([18F]fluoroethyltyrosine; [18F]FET)

Aqueous solution of [18F]FET, EtOH, ascorbic acid, buffer, + other excipients

Aqueous solution of [18F]fluoride

O-tosyloxyethyl-N-trityl-tyrosine tert-butyl ester

[68Ga]Ga-Edotreotide ([68Ga]Ga-DOTA-TOC)

Aqueous solution of 68Ga- peptide, unlabelled excess of the peptide, ascorbic acid, buffer, + other excipients

68Ga-gallium chloride ([68Ga]GaCl3)

DOTA-TOC

[177Lu]Lu-Edotreotide ([177Lu]Lu-DOTA-TOC)

Aqueous solution of 177Lu-peptide, unlabelled excess of the peptide, ascorbic acid, buffer, + other excipients

177Lu-lutetium chloride ([177Lu]LuCl3)

DOTA-TOC