[11C]PBR28 FOR INJECTION: VALIDATION RUNS

PET Radiopharmaceutical Sciences Section, Date of review: 09/20/05

Molecular Imaging Branch,

National Institute of Mental Health,

National Institutes of Health,

Bldg. 10, Rm. B3 C338,

Bethesda, MD 20892

List of Contents

Page

(A)  Data Summary of Validation Runs 10-2

(B)  Batch Records

1.  Batch PBR-05090101...... 10-4

2.  Batch PBR-05090102...... 10-24

3.  Batch PBR-05091401...... 10-43


Summary of Data from Validation Runs

Three validation runs of [11C](R)-Rolipram for Injection have been made. A summary of data from the three validation runs is listed below.

1.  Production Data on Validation Runs of [11C]PBR28 for Injection:

Table1. The non-decay-corrected radiochemical yields of [11C](R)-Rolipram for Injection in validation runs.

Batch # (validation runs) / Starting radioactivity
(Ci) / Radioactivity
of the product
at EOS†
(mCi) / Non-decay corrected
radiochemical
yield
(%)
PBR-05090101 / 1.4 / 115 / 8.2
PBR-05090102 / 1.4 / 139 / 9.9
PBR-05091401 / 1.4 / 96.9 / 6.9
Average / 1.4 / 117 / 8.3

†End of Synthesis

See attached production and radio-chromatograms of each validation run (Master Batch Sheet).

2. Quality Control:

Table 2. Chemical purity, radiochemical purity and specific activity of [11C]PBR28 for Injection from validation runs.

Batch #
(validation runs) / Chemical
purity
(area %) / Radiochemical
purity
(area %) / Specific
radioactivity
at EOS†
(mCi/µmol)
PBR-05090101 / 97.42 / 100 / 2639
PBR-05090102 / 96.28 / 100 / 2498
PBR-05091401 / 100.0 / 100 / 2352
Average / 97.9 / 100 / 2496

See attached production UV and radio-chromatograms of each validation run (Master Batch Sheet). All other criteria for release were met in all three validation runs.

3. The Radiochemcial Stability of [11C]PBR28 for Injection

Table 3. The radiochemical stability of [11C]PBR28 for Injection tested at expiry time (60 minutes after end of synthesis).

Batch # / Time
after EOS
(h) / Radiochemical
purity
(% ) / Vial
integrity
PBR-05090101 / 1.0 / 100 / clear
PBR-05090102 / 1.0 / 100 / clear
PBR-05091401 / 1.0 / 100 / clear

These data clearly show that [11C]PBR28 for Injection is radiochemically stable at the expiry time.

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Document 10: [11C]PBR28 for Injection