Skip to main content

Table 1 Summary Table of [13N]Ammonia Injection Stability Test Average Results from Five Batches compared to the FDA/USP Test Specifications

From: Development, validation and regulatory acceptance of improved purification and simplified quality control of [13N] Ammonia

Quality control specification

Acceptance criteria

Average result

Activity at End of Synthesis

1.11–76.96 GBq @ EOS

30 to 2080 mCi @EOS

10.18 ± 0.22 GBq

572 ± 60 mCi

Product Volume

8 mL ± 20%

7.61 ± 0.2 mL

pH Determination

4.5–7.5

5

Visual Inspection

Clear, colorless solution. Absent of foreign matter. Product vial is intact.

Pass

Radionuclidic Identity

Principal photopeaks are found at 0.511 MeV, 1.02 MeV and Compton scatter

Pass

Half-life Determination (minutes)

The measured half-life is between 9.5–10.5 min

9.99 ± 0.1 min

Radiochemical Identity

Rf of resazurin = 0.43–0.63

0.5 ± 0.05

Radiochemical Purity

NLT 95.0% Ammonia N 13 via TLC

98.61 ± 0.4%

Residual Solvent Assay

Ethanol NMT 3.1 mg/mL

<LLOD to 0.5 mg/mL

Sterile Filter Integrity

≥ manufacturer specification of 46 psi

> 46 psi

Bacterial Endotoxin Testing (EU/mL)

NMT 10.9 EU/mL

< 5 EU/mL

Sterility

Sterile

Sterile

Long Lived Radionuclidic Purity

< 0.5% at time of expiry

< 0.001%

(less than lower limit of detection)

  1. Abbreviations: EOS end of synthesis, EU endotoxin units, LLOD lower limit of detection, NLT not less than, NMT not more than