for production of 2-[ F]-fluoro-2-deoxy-D-glucose with the

Transcription

1 Reagents Kit 18 for production of 2-[ F]-fluoro-2-deoxy-D-glucose with the GE TRACERlab MX FDG Module Catalog No.: RK-100 Date of Manufacturing: Sep Lot No.: RK Expiry Date: Sep Product description The RK-100 Reagents Kit was designed to be used with GE TRACERlab MX FDG Module for the production of 2-[ 18 F]-fluoro-2-deoxy-D-glucose. The RK-100 is to be stored in a cool and dry environment and protected from light. The Reagents Kit contains the following components: Reagent Content Vial size Eluent solution 600 µl ±20µl 1.2ml Acetonitrile 7.0 ml ±0.2ml 8ml Ethanol 5.0 ml ±0.2ml 8ml NaOH solution, 2.0M±1% 1.0 ml ±0.05ml 3ml Syringe Buffer solution 6.0 ml ±0.2ml 8ml Mannose Triflate Shipped separately (content is at customer s request.) Manufactured according to cgmp API Tested for sterility and Bacterial endotoxins ISO 9001:2000 and ISO 14001:2004 certified CAUTION! Care must be used when handling this product. Do not contact skin or eyes Do not ingest or inhale. Production Quality Control Dr. Zhihong Xu Date: Sep Jian Zhu Date: Sep Page 1 of 7

2 Certificate of Analysis Eluent solution Lot No.: ES The Eluent solution is a mixture of the following compounds: Cryptand mg ±1.0 mg Potassium carbonate 7.0 mg ±0.5 mg Acetonitrile 300µl ±10µl Sterile water for injection 300µl ±10µl Dissolve the Cryptand 222 in the Acetonitrile; Dissolve the Potassium carbonate in the water. Then mix both solutions together. Draw 600µl ± 20µl of the solution from the stock mixture and transfer it into the 1.2ml vial. Then cap and crimp. Bacterial endotoxins <2.0 I.U./ml <0.5 I.U./ml Cryptand 222 Lot No.: Appearance White or off-white crystals White crystals Purity (GC) 99.0% 99.9% Melting range H-NMR Conforms Conforms Potassium carbonate Lot No.: 05922PD Appearance white White powder and/or chunks GRANULAR POWDER Titration 42.4% % CO 3 (with HCl) 43.3% CO 3 (with HCl) Trace analysis, ICP TRACE 50 PPM (Maximum) Trace Metallic Elements in PPM. Impurities ICP Assay Confirms potassium component Confirms potassium component Purity 99.9% >99.995% based on trace metals analysis Acetonitrile Lot No.: AT Residue on evaporating 0.001% % Appearance Colorless Liquid Conforms Infrared Spectrum Conforms Conforms Page 2 of 7

3 Gas Liquid Chromatography 99.75% 99.9% Water 0.05% 0.05% Sterile water for injection Lot No.: Appearance Colorless liquid Conforms PH Passes test Conductivity 5 μs/cm Passes test Chloride (Cl) 0.2 ppm Passes test Sulphate (SO4) 0.2 ppm Passes test Calcium (Ca) 0.2 ppm Passes test Magnesium (Mg) 0.2 ppm Passes test Nitrate 0.2 ppm Passes test Heavy Metals 0.1 ppm Passes test Visible matter None Passes test Acetonitrile Lot No.: AT ml±0.2ml of extra-pure Acetonitrile is introduced into the relevant vial, which is then plugged with a rubber stopper and crimped with the blue crimp cap. Bacterial endotoxins 2.0 I.U./ml < 0.5 I.U./ml Residue on evaporating 0.001% % Appearance Colorless liquid Conforms Infrared Spectrum Conforms Conforms Gas Liquid Chromatography 99.75% 99.9% Water 0.05% 0.05% Ethanol Lot No.:ET ml±0.2ml of pure ethanol is introduced into the relevant vial, which is then plugged with a rubber stopper and crimped with the golden crimp cap. Bacterial endotoxins 2.0 I.U./ml < 0.5 I.U./ml Purity (GC) 99.7% 99.9% Appearance Conforms Conforms Solubility in water Conforms Conforms Acidity or alkalinity Conforms Conforms Page 3 of 7

4 Density (d 20 /20 ) UV absorption Conforms Conforms Aldehydes (as Acetaldehyde) 0.005% 0.001% Fusel oils Conforms Conforms Substances reducing % % potassium permanganate (as O) Carbonyl compounds (as CO) 0.003% 0.003% Readily carbonizable Conforms Conforms substances Volatile impurities (GC) Conforms Conforms Acetaldehyde and Acetal (GC) 0.005% 0.001% Acetone (GC) 0.005% 0.001% Benzene (GC) % % Ethylmethylketone (GC) 0.03% 0.02% Isoamyl alcohol (GC) 0.05% 0.05% Methanol (GC) 0.03% 0.02% 2-Propanol (GC) 0.005% 0.003% Total of other impurities (GC) 0.04% 0.03% Higher alcohols (GC) 0.01% 0.01% Chloride (Cl) 0.5 ppm 0.3 ppm Nitrate (NO 3 ) 0.5 ppm 0.3 ppm Phosphate (PO 4 ) 0.5 ppm 0.3 ppm Sulphate (SO 4 ) 0.5 ppm 0.3 ppm Ag (Silver) % % Al (Aluminium) % % As (Arsenic) % % Au (Gold) % % Ba (Barium) % % Be (Beryllium) % % Bi (Bismuth) % % Ca (Calcium) % % Cd (Cadmium) % % Co (cobalt) % % Cr (Chromium) % % Cu (copper) % % Fe (Iron) % % Ga (Gallium) % % In (Indium) % % Li (Lithium) % % Mg (Magnesium) % % Page 4 of 7

5 Mn (Manganese) % % Mo (Molybdenum) % % Ni (Nickel) % % Pb (Lead) % % Pt (Platinum) % % Sb (Antimony) % % Sn (Tin) % % Ti (Titanium) % % Tl (Thallium) % % V (Vanadium) % % Zn (Zinc) % % Zr (Zirconium) % % Evaporation residue 0.001% % Water 0.1% 0.1% NaOH solution, 2M±1% Lot No.: SH ml ±0.05ml of NaOH 2.0 M ±1% is drawn into a 3 ml luer lock syringe which is closed by a female polypropylene(pp) Luer lock plug. A small air bubble is tolerated. Bacterial endotoxins < 2.0 I.U./ml <0.5 I.U./ml Assay (acidimetric,naoh) 99% 99% Carbonate (as Na 2 CO 3 ) 1.0% 1.0% Chloride (Cl) 0.001% % Phosphate (PO 4 ) % % Silicate (SiO 2 ) 0.005% 0.001% Sulphate (SO 4 ) 0.001% % Total nitrogen (N) % % Heavy metal (as Pb) 0.001% % Al (Aluminium) 0.001% % As (Arsenic) % % Ca (Calcium) 0.001% % Cu (copper) % % Fe (Iron) % % K (Potassium) 0.05% 0.05% Mg (Magnesium) 0.001% % Ni (Nickel) 0.001% % Pb (Lead) % % Zn (Zinc) 0.002% 0.001% Page 5 of 7

6 Buffer solution Lot No.: BS The Buffer solution is a mixture of the following compounds: Sodium citrate dibasic sesquihydrate 25mg ±0.1 mg Tri-sodium citrate-2-hydrate 144.5mg ±0.5 mg Hydrochloric acid 2M 1.0 ml ±0.05 ml Sterile water for injection 5.0ml ±0.1 ml Introduce the mixture into the relevant vial which then is plugged with rubber stopper and crimped with the green crimp cap. Bacterial endotoxins <2.0 I.U./ml <0.5 I.U./ml Sodium citrate dibasic sesquihydrate, purum p.a., 99.0% Lot No. : (T) Appearance (color) White Conforms Appearance (form) Fine crystals Conforms Titration(T) NaOH 0.1N 99.0% 99.5 % Solubility (Color) Colorless Colorless Solubility (Turbidity) Clear Clear (<3.5 NTU) Calcium (ICP) < 50 mg/kg Passes test Cadmium (ICP) < 50 mg/kg Passes test Cobalt (ICP) < 50 mg/kg Passes test Copper (ICP) < 50 mg/kg Passes test Iron (ICP) < 50 mg/kg Passes test Potassium (ICP) < 100 mg/kg Passes test Nickel (ICP) < 50 mg/kg Passes test Lead (ICP) < 50 mg/kg Passes test Zinc (ICP) < 50 mg/kg Passes test Chloride (Cl) < 50 mg/kg Passes test Sulfate (SO 4 ) < 50 mg/kg Passes test Tri-sodium citrate-2-hydrate Lot No.: A Assay 99% % Identity Conforms Conforms Clarity of solution Conforms Conforms insoluble matter 0.01% 0.005% Acidity or alkalinity Conforms Conforms Chloride (Cl) 0.005% 0.001% Page 6 of 7

7 Oxalate 0.05% 0.03% Phosphate (PO 4 ) 0.01% 0.002% Sulphate (SO 4 ) 0.01% 0.004% Total nitrogen (N) 0.01% 0.001% Heavy metals (as Pb) 0.001% % Ca (Calcium) 0.005% 0.005% Fe (Iron) 0.005% % NH 4 (Ammonium) 0.005% 0.003% Readily carbonisable Passes test Passes test substance Water % % Hydrochloric acid 2M Lot No.: Assay 36.0~38.0% 36.0~38.0% Surface appearance Conforms Conforms Residue after % % Evaporation (as SO 4 ) Free chloride % % Sulfate(SO 4 ) % % Sulfite(SO 3 ) % % Iron % % Copper % % Arsenic % % Tin % % Heavy metals (as Pb) % % Sterile water for injection Lot No.: Appearance Colorless Liquid Conforms PH Passes test Conductivity 5 μs/cm Passes test Chloride (Cl) 0.2 ppm Passes test Sulphate (SO 4 ) 0.2 ppm Passes test Calcium (Ca) 0.2 ppm Passes test Magnesium (Mg) 0.2 ppm Passes test Nitrate 0.2 ppm Passes test Heavy Metals 0.1 ppm Passes test Visible matter None Passes test According to Chinese pharmacopeia version 2005 Second Edition. Page 7 of 7