[18F]FALLYPRIDE FOR INJECTION: QUALITY CONTROL RECORD
PET Radiopharmaceutical Sciences Section,
Molecular Imaging Branch,
National Institute of Mental Health,
National Institutes of Health,
Bldg. 10, Rm. B3 C338,
Bethesda, MD 20892
Date of review: 05/17/04
Approved by:_____________________________
Initials___________
Date:_______
Victor W Pike, Ph.D
Chief, PET Radiopharmaceutical Sciences, NIMH
Batch # FAY-___________ Date________
Part I: Summary of QC Data
Test
Result
1.
Vial integrity (Visual inspection)
_______
2.
Solution free of particulates (Visual inspection)
_______
3.
pH of the
[18F]Fallypride
for Injection (pH paper):
Specification: (within range of 4.5−7.5)
4.
pH: _______
Validation of analytical system (SOP # QA305)
Column: Prodigy ODS (10 µm; 4.6 X 250 mm; 100 Å)
Mobile phase: Acetonitrile-5 mM ammonium formate (50: 50 v/v) at 1 mL/min
Absorbance detector: set at 305 nm
Inject 20−50 ng of reference fallypride into HPLC system. The corresponding UV area is
expected to be 100 ± 10% of UV area based on the calibration curve
Rt =__________min.
5.
Recovery: ________%
Radiochemical purity (SOP # QA305)
Specifications: ≥ 90% radiochemical purity
_________%
Volume of sample injected: 50−100 µL
6. Specific radioactivity (SR):
Specification > 500 mCi/µmol at EOS
________mCi/µmol at ___________
7. Chemical purity (SOP # QA305)
Specifications: ≥ 90% chemical purity
Rt =__________min.
___________%
8. Organic residues in [18F]Fallypride for Injection (SOP # QA304)
Criteria: ≤ 0.04% (wt/Ʋ), acetonitrile; ≤ 10% (wt/Ʋ) dehydrated alcohol.
Test completed on every 10th batch after release of drug product of [18F]Fallypride for
Injection.
Yes _______No ______ (see GC chromatogram and report)
9. Expiry time
[18F]Fallypride for Injection expires at 4 h from EOS.
10. Membrane filter integrity test (SOP # GP104)
Document 3. [18F]Fallypride for Injection: Quality Control Record
Expiry time: ________________
Pass: Yes_______No ______
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[18F]FALLYPRIDE FOR INJECTION: QUALITY CONTROL RECORD
PET Radiopharmaceutical Sciences Section,
Molecular Imaging Branch,
National Institute of Mental Health,
National Institutes of Health,
Bldg. 10, Rm. B3 C338,
Bethesda, MD 20892
Date of review: 05/17/04
This batch has met all the quality control criteria:
Chemist __________________________Initials__________________
Batch # FAY-____________
Date_____________
Date_____________
Part II: Quality Control and Radiochemistry Record (SOP # QA305)
1. Validation of HPLC system and Ionization Chamber
Conditions for QC:
Instruments used in QC:
Column: Prodigy C-18 ODS (10 µm; 100 Å, 4.6 X 250 mm)
Pump: Beckman 166
Mobile phase: Acetonitrile: ammonium formate (50: 50 v/v)
Radioactivity detector: Bioscan
Flow rate: 1 mL/min.
UV Detector: Beckman
UV detector wavelength: 305 nm
(A) Validation of HPLC system: Inject 20−50 ng of reference fallypride into HPLC system.
Amount injected ___________nmol; Retention time: ________ min
Area of UV peak ____________ = _________nmol (standard curve). Recovery:________% (> 90%)
(B) Validation of ionization chamber in hot-cell 5; see page 4.
2. Chemical Purity (≥ 90% based on UV area).
Inject 50−100 L of [18F]Fallypride for Injection into HPLC system. See UV chromatogram.
UV Area of fallypride __________________. Rt (fallypride) ___________min.
Chemical purity of fallypride (excluding excipient peak(s))____________%
Mass (nmol) = (UV Area (fallypride peak) - 614.01) / (355.024*364.45)
= ____________nmol (based on the standard curve)
3. Radiochemical purity and specific radioactivity
Inject 50−100 L of [18F]Fallypride for Injection into HPLC system (see 2).
(A) Volume of [18F]Fallypride for Injection sample injected: ________µL (1) in saline ____ (2) in
ethanol______
Pre-injection ___________µCi at ___________
Left in syringe __________µCi at _________ __= ___________µCi at ____ ____(decay corrected)
Document 3. [18F]Fallypride for Injection: Quality Control Record
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[18F]FALLYPRIDE FOR INJECTION: QUALITY CONTROL RECORD
PET Radiopharmaceutical Sciences Section,
Molecular Imaging Branch,
National Institute of Mental Health,
National Institutes of Health,
Bldg. 10, Rm. B3 C338,
Bethesda, MD 20892
Date of review: 05/17/04
Radioactivity injected ______________ µCi at _____________
(B) Radiochemical purity of [18F]Fallypride for Injection
Rt ([18F]Fallypride) =____________min.
Radiochemical purity ________________ % (Radioactivity channel in HPLC Chromatography)
(C) Specific radioactivity (SR) calculation
SR = __________________mCi/µmol at____________
= __________________mCi/µmol at____________ (EOS)
=__________________ mCi/µmol at____________ (EOB)
4. Expiry time calculation
This is calculated as the sooner of i) latest time that less than 2.0 µg (5.473 nmol) of Fallypride for
Injection can be injected with a 5 mCi radioactivity dose, or ii) 4 h after EOS. The expiry time can be
calculated from the following data:
Volume of whole batch _______________mL.
Radioactivity of whole batch: _________________mCi at____________
Radioconcentration _______________mCi/mL at __________________
The mass of fallypride in whole batch _______________µg
This batch of [18F]Fallypride for Injection expires by _______________Batch # FAY-________ ___ _
Date:____________
5. Analysis of organic residues (SOP # QA304 and see gas chromatogram)
≤ 0.04% (wt/v), acetonitrile, ≤ 10% (wt/v) dehydrated and alcohol. (Test completed on every 10th batch
after release of drug product of [18F]Fallypride for Injection)
Chemist __________________________Initials__________________
Batch # FAY-____________
Document 3. [18F]Fallypride for Injection: Quality Control Record
___________
Date_____________
Date_____________
Page 3 of 4
[18F]FALLYPRIDE FOR INJECTION: QUALITY CONTROL RECORD
PET Radiopharmaceutical Sciences Section,
Molecular Imaging Branch,
National Institute of Mental Health,
National Institutes of Health,
Bldg. 10, Rm. B3 C338,
Bethesda, MD 20892
Date of review: 05/17/04
Validation of ionization chamber in Hot-Cell 5
Cs-137 source reference # 970-31-4 204 μCi on 03/1/2003
Expected radioactivity on date of this test _____________ μCi on _____________ (use Excel Speadsheet on bench top HPLC computer)
Acceptable range of radioactivity _____________to______________μCi.
Measured radioactivity ____________ μCi on _____________(Remember to push Cs-137 button on
dose calibrator, Bioscan Medical System)
Does measured radioactivity fall within acceptable range (within 5% of expected value)?
Yes or No (Circle one)
Co-57 source reference # 970-32-8 204 μCi on 03/1/2003
Expected radioactivity on date of this test _____________ mCi on _____________ (use Excel
Speadsheet on bench top HPLC computer)
Acceptable range of radioactivity _____________to______________mCi.
Measured radioactivity ____________ mCi on _____________(remember to push Co-57 button on dose
calibrator; Bioscan Medical System)
Does measured radioactivity fall within acceptable range (with 5% of expected value)?
Yes or No (Circle one)
Chemist __________________________Initials__________________
Batch # FAY-____________
Document 3. [18F]Fallypride for Injection: Quality Control Record
Date_____________
Date_____________
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