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Table 4 QC Data for [13N]NH3 validation runs. All doses met or exceeded release criteria for clinical application at the University of Michigan

From: Development and implementation of ISAR, a new synthesis platform for radiopharmaceutical production

QC Tests

Specifications

Lot 1

Lot 2

Lot 3

Visual Inspection

Clear, colorless, no ppt

Pass

Pass

Pass

Radiochemical-ID

RRTa: 0.9–1.1

0.94

0.95

0.97

Radionuclidic-ID

t1/2: 9.5–10.5 min

9.99

9.97

10.00

Filter integrity

Bubble point ≥50 psi

53

61

62

Endotoxins

≤43.75 EU/mL

< 2.00

< 2.00

< 2.00

Sterility

No microbial growth

Pass

Pass

Pass

pH value

4.5–7.5

5.0

5.0

5.0

RCP

≥90%

> 99.9%

> 99.9%

> 99.9%

  1. a RRT (Relative Retention Time) = tR [13N]NH3/tR NH3 standard