RADIOGENIX SYSTEM Technetium tc 99m generator injection Ref.[10398] Active ingredients: Technetium ⁹⁹ᵐTc pertechnetate

Source: FDA, National Drug Code (US) Revision Year: 2020

Product description

Chemical Characteristics

The RadioGenix System provides Sodium Pertechnetate Tc 99m Injection, USP for intravenous use, intravesicular use, ophthalmic use, or for preparing radiopharmaceutical kits. The RadioGenix System uses a non-uranium potassium molybdate Mo-99 source solution to produce Sodium Pertechnetate Tc 99m Injection, USP. The RadioGenix System uses potassium molybdate Mo-99 sources at an activity of 6 Ci/29 mL (222 GBq) at the date and time of calibration.

Elution of RadioGenix System produces Sodium Pertechnetate Tc-99m (Na99mTcO4) in approximately 5 mL of sterile 0.9% sodium chloride injection solution. The activity of Sodium Pertechnetate Tc-99m produced varies (30 mCi/mL to 1,153 mCi/mL of technetium Tc-99m) and depends on the activity of potassium molybdate Mo-99 present in the source container originally, the decay time since the calibration time, and the elapsed time since the previous Sodium Pertechnetate Tc-99m elution.

Sodium Pertechnetate Tc-99m is an inorganic compound with the formula Na99mTcO4. In solution, Sodium Pertechnetate exists as dissociated Na+ cations and pertechnetate TcO4-anions with the following molecular structure:

The eluted Sodium Pertechnetate Tc 99m Injection, USP is a sterile, non-pyrogenic, clear, and colorless solution. The pH of the solution is between 4.5 and 7.5.

Physical Characteristics

Technetium Tc-99m

Technetium Tc-99m decays by isomeric transition with a physical half-life of 6.01 hours. The principal photon that is useful for detection and imaging studies is shown in Table 8.

Table 8. Principal Radiation Emission Data technetium Tc-99m:

Radiation	Mean Percent Per Disintegration	Energy (keV)
Gamma-2	88.5	140.5

The air-kerma-rate (exposure-rate) constant for technetium Tc-99m is 5.23 m²·pGy·(MBq)-1·s-1 [0.795 cm²·R·(mCi)-1·h-1]. A range of values for the relative radiation attenuation by the various thicknesses of Pb is shown in Table 9. For example, the use of 3 mm thickness of Pb will attenuate the radiation exposure by a factor of about 1,000.

Table 9. Radiation Attenuation by Lead Shielding:

Shield Thickness (Pb) mm	Coefficient of Attenuation
0.25	0.5
1	10^-1
2	10^-2
3	10^-3
4	10^-4

Molybdenum Mo-99

Molybdenum Mo-99 decays to technetium Tc-99m with a molybdenum Mo-99 half-life of 66 hours. This means that 77.7% of the activity remains after 24 hours; 60.4% remains after 48 hours, see Table 10.

Table 10. Molybdenum Mo-99 Decay Chart half-life 66.0 hours:

Days	Percent Remaining	Days	Percent Remaining
0*	100	10	8
1	77.7	11	6.3
2	60.4	12	4.9
3	46.9	13	3.8
4	36.5	14	2.9
5	28.4	15	2.3
6	22.0	20	0.6
7	17.1	25	0.2
8	13.3	30	0.1
9	10.3

* calibration time

The physical decay characteristics of molybdenum Mo-99 are such that 88.6% of the decaying molybdenum Mo-99 atoms form Technetium Tc-99m. RadioGenix System elutions may be made at any time, but the amount of technetium Tc-99m available will depend on the time interval measured from the last elution cycle. Eluting the RadioGenix System every 24 hours will provide the maximal yield of Sodium Pertechnetate Tc-99m.

To correct for physical decay of technetium Tc-99m, the fractions that remain at selected intervals of time are shown in Table 11.

Table 11. Physical Decay Chart. Technetium Tc-99m, half-life 6.01 Hours:

Hours	Percent Remaining	Hours	Percent Remaining
0*	100	7	44.7
1	89.1	8	39.8
2	79.4	9	35.5
3	70.8	10	31.6
4	63.1	11	28.2
5	56.2	12	25.1
6	50.1

* calibration time

RadioGenix System 1.2

Chemical Characteristics

Elution of RadioGenix System produces Sodium Pertechnetate Tc-99m (Na99mTcO4) in approximately 5 mL of sterile 0.9% sodium chloride injection solution. The activity of Sodium Pertechnetate Tc-99m produced varies (25 mCi/mL to 1,015 mCi/mL of technetium Tc-99m) and depends on the activity of potassium molybdate Mo-99 present in the source container originally, the decay time since the calibration time, and the elapsed time since the previous Sodium Pertechnetate Tc-99m elution.

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The eluted Sodium Pertechnetate Tc 99m Injection, USP is a sterile, non-pyrogenic, clear, and colorless solution. The pH of the solution is between 4.5 and 7.5.

Physical Characteristics

Technetium Tc-99m

Technetium Tc-99m decays by isomeric transition with a physical half-life of 6.01 hours. The principal photon that is useful for detection and imaging studies is shown in Table 8.

Table 8. Principal Radiation Emission Data technetium Tc-99m:

Radiation	Mean Percent Per Disintegration	Energy (keV)
Gamma-2	88.5	140.5

Table 9. Radiation Attenuation by Lead Shielding:

Shield Thickness (Pb) mm	Coefficient of Attenuation
0.25	0.5
1	10 ^-1
2	10 ^-2
3	10 ^-3
4	10 ^-4

Molybdenum Mo-99

Molybdenum Mo-99 decays to technetium Tc-99m with a molybdenum Mo-99 half-life of 66 hours. This means that 77.7% of the activity remains after 24 hours; 60.4% remains after 48 hours, see Table 10.

Table 10. Molybdenum Mo-99 Decay Chart half- life 66.0 hours:

Days	Percent Remaining	Days	Percent Remaining
0*	100	10	8
1	77.7	11	6.3
2	60.4	12	4.9
3	46.9	13	3.8
4	36.5	14	2.9
5	28.4	15	2.3
6	22.0	20	0.6
7	17.1	25	0.2
8	13.3	30	0.1
9	10.3

* calibration time

To correct for physical decay of technetium Tc-99m, the fractions that remain at selected intervals of time are shown in Table 11.

Table 11. Physical Decay Chart. Technetium Tc-99m, half-life6.01 Hours:

Hours	Percent Remaining	Hours	Percent Remaining
0*	100	7	44.7
1	89.1	8	39.8
2	79.4	9	35.5
3	70.8	10	31.6
4	63.1	11	28.2
5	56.2	12	25.1
6	50.1

* calibration time

Dosage Forms and Strengths
The RadioGenix System provides Sodium Pertechnetate Tc 99m Injection, USP from a non-highly enriched uranium source of potassium molybdate Mo-99, as a clear, colorless solution containing 30 mCi/mL to 1,153 mCi/mL (1,110 to 42,661 MBq/mL) of technetium Tc-99m radioactivity in approximately 5 mL of volume. The amount of Tc-99m radioactivity depends on the radioactivity in the potassium molybdate Mo-99 source. The source is supplied in vessels containing 6 Ci (222 GBq) at the date and time of calibration. RadioGenix System 1.2 The RadioGenix System provides Sodium Pertechnetate Tc 99m Injection, USP, from a non-highly enriched uranium source of potassium molybdate Mo-99, as a clear, colorless solution containing 25 mCi/mL to 1,015 mCi/mL (925 to 37,555 MBq/mL) of technetium Tc 99m radioactivity in approximately 5 mL of volume. The amount of Tc-99m radioactivity depends on the radioactivity in the potassium molybdate Mo-99 source. The source is supplied in vessels containing 6 Ci (222 GBq) at the date and time of calibration.

Dosage Forms and Strengths

The RadioGenix System provides Sodium Pertechnetate Tc 99m Injection, USP from a non-highly enriched uranium source of potassium molybdate Mo-99, as a clear, colorless solution containing 30 mCi/mL to 1,153 mCi/mL (1,110 to 42,661 MBq/mL) of technetium Tc-99m radioactivity in approximately 5 mL of volume. The amount of Tc-99m radioactivity depends on the radioactivity in the potassium molybdate Mo-99 source. The source is supplied in vessels containing 6 Ci (222 GBq) at the date and time of calibration.

RadioGenix System 1.2

The RadioGenix System provides Sodium Pertechnetate Tc 99m Injection, USP, from a non-highly enriched uranium source of potassium molybdate Mo-99, as a clear, colorless solution containing 25 mCi/mL to 1,015 mCi/mL (925 to 37,555 MBq/mL) of technetium Tc 99m radioactivity in approximately 5 mL of volume. The amount of Tc-99m radioactivity depends on the radioactivity in the potassium molybdate Mo-99 source. The source is supplied in vessels containing 6 Ci (222 GBq) at the date and time of calibration.

How Supplied

The RadioGenix System is a technetium tc-99m generator supplied and installed by NorthStar Medical Radioisotopes, LLC. It produces Sodium Pertechnetate Tc 99m Injection from a non-uranium potassium molybdate Mo-99 source solution. The potassium molybdate Mo-99 source solution is shielded within a source container which completely encases a vial that contains 29 mL of solution. NorthStar supplies potassium molybdate Mo-99 solution with the referenced calibration date and time specified on the container label (Table 12).

Table 12. Potassium Molybdate Mo-99 Solution Containers:

Mo-99 Activity at Time of Calibration		Product Number	NDC Number
Curies	Gigabecquerels	Product Number	NDC Number
6.0	222	40P03246	71612-006-01

The following kits (Tables 13-17) are used in the operation of the RadioGenix System as described in the RadioGenix System Operator Guide 1.0a and 1.1, (94S05058).

Table 13. Materials Supplied in Source Vessel Kit for RadioGenix System, p/n 40P05047:

Component Description	Component Part Number	Qty.
Catheter	77P07937	1
Air Filter	77C01237	1
Manifold	12D09014	1
Absorbent Cloth	73C05400	1
Black Cap	77C01489	1
Cap	77C05450	1
Luer Cap	77C05449	1

Table 14. Materials Supplied in Reagent Kit for RadioGenix System, p/n 40P05044:

Component Description	Component Part Number	Qty.
Reagents	16P04143	1
Primary Separation Cartridge (PSC)	40P03354	1
Hydrogen Peroxide Wipe	16C07455	5

Table 15. Materials Supplied in Tc-99m Product Kit for RadioGenix System, p/n 40P05045:

Component Description	Component Part Number	Qty.
Tc-99m Product Cartridge (TPC)	40P04600	1
Tc-99m Collection Vial	77C01318	1
Saline Syringe	16C05227	1
Product Port Cap	16C05212	1
Cap	16C04989	1
Hydrogen Peroxide Wipe	16C07455	3

Table 16. Materials Supplied in Sterilization Kit for RadioGenix System, p/n 40P05043:

Component Description	Component Part Number	Qty.
Blank Primary Separation Cartridge (PSC)	40P04578	1
Blank Tc-99m Product Cartridge (TPC)	40P05377	1
Spike	NA	1
Air Filter	77C01237	1
Cap	16C04989	7
Product Port Cap	16C05212	1
Purge Water Container	77C05585	1
Sterile Water for Injection (SWFI)	16C04488	1
Hydrogen Peroxide Wipe	16C07455	13
Product Vial	NA	1

Table 17. Materials Supplied in Discarded Material Kit for RadioGenix System, p/n 40P05046:

Component Description	Component Part Number	Qty.
Discarded Material Container	12D05146	1
Silicone Tubing	77C05431	1
Luer Cap	77C05449	1

RadioGenix System 1.2

The RadioGenix System is a technetium Tc 99m generator supplied and installed by NorthStar Medical Radioisotopes, LLC. It produces Sodium Pertechnetate Tc 99m Injection, USP from a non-uranium potassium molybdate Mo-99 source solution. The potassium molybdate Mo-99 source solution is shielded within a source container which completely encases a vial that contains 29 mL of solution. NorthStar supplies potassium molybdate Mo-99 solution with the referenced calibration date and time specified on the container label (Table 12).

Table 12. Potassium Molybdate Mo-99 Solution Containers:

Mo-99 Activity at Time of Calibration		Product Number	NDC Number
Curies	Gigabecquerels	Product Number	NDC Number
6.0	222	40P03246	71612-006-01

The following kit and packs and consumables (Tables 13-22) are used in the operation of the RadioGenix System as described in the Operator Guide, RadioGenix System 1.2 (SYS-0028) or Operator Guide, RadioGenix System 1.2 (SYS-0060) P/N 40010570.

Table 13. Materials Supplied in Source Vessel Kit for RadioGenix System, PN 40P07954:

Component Description	Component Part Number	Qty.
Catheter	77P07937	1
Air Filter*	77C01237	1
Manifold	12D09657	1
Absorbent Cloth	73C05400	1
Black Cap	77C01489	1
Female Luer Cap*	77C05449	1
Male Luer Cap*	77C05450	1
Only used in the removal of a source vessel

Table 14. Materials Supplied in Primary Separation Cartridge (PSC) Pack for RadioGenix System 1.2, PN 40P09451:

Component Description	Component Part Number	Qty.
Primary Separation Cartridge (PSC)*	40P09852	1
Hydrogen Peroxide Wipe*	16C07455	4
Tubing Assembly*	77P09748	1

Table 15. Materials Supplied in Elution Pack for RadioGenix System 1.2, PN 40P09452:

Component Description	Component Part Number	Qty.
Tc-99m Product Cartridge (TPC)*	40P09853	1
Tc-99m Collection Vial	77C01318	1
Product Port Cap*	77C05449	1
Alcohol Wipe*	16C02704	2
Tc-99m Collection Vial Shield Label	53D09964	1

Table 16. Materials Supplied in Sterilization Pack for RadioGenix System 1.2, PN 40P09444:

Component Description	Component Part Number	Qty.
Blank Primary Separation Cartridge (PSC)*	40P09749	1
Blank Tc-99m Product Cartridge (TPC)*	40P09850	1
Air Filter*	77C01237	1
Product Port Cap*	77C05449	1
Luer Plugs	77C05450	3
Purge Water Container	77C05585	1
Hydrogen Peroxide Wipe*	16C07455	9
Product Vial Label	53D06430	1
Tubing Assembly	77P09800	1
Product Vial	77C01318	1

Table 17. Materials Supplied in Discarded Material Pack for RadioGenix System 1.2, PN 40P09854:

Component Description	Component Part Number	Qty.
Discarded Material Container	12D05146	1
Silicone Tubing	77C05431	1
Luer Cap*	77C05449	1

Table 18. Materials Supplied in Discarded Material Type A Pack for RadioGenix System 1.2, PN 40P09855:

Component Description	Component Part Number	Qty.
Discarded Material Container	12D05146	1
Silicone Tubing	77C05431	1
Luer Cap*	77C05449	1
DMC Return Pack	40P10086	1

Table 19. Materials Supplied in Saline Tubing Pack for RadioGenix System 1.2, PN 40P09453:

Component Description	Component Part Number	Qty.
Hydrogen Peroxide Wipe*	16C07455	1
Saline Tubing*	77P09747	1

The following consumables are shipped in bulk to the customer from NorthStar:

Table 20. SWFI for RadioGenix System 1.2, PN 16C04488:

Component Description	Component Part Number	Qty.
Sterile Water for Injection, Bag, 250 mL*	16C04488	24

Table 21. NaOH for RadioGenix System 1.2, PN 16P09302:

Component Description	Component Part Number	Qty.
5M Sodium Hydroxide (NaOH), NF, 120 mL*	16P09302	6

Table 22. Saline for RadioGenix System 1.2, PN 16C09849:

Component Description	Component Manufacturer NDC	Qty.
NaCl, Injection 0.9%, 250 mL Bag, USP*	0264-7800-20	12, 24, 36
NaCl, Injection 0.9%, 500 mL Bag, USP*	0264-7800-10	12, 24, 36
NaCl, Injection 0.9%, 500 mL Bottle, USP*	0264-7800-01	12, 24, 36
NaCl, Injection 0.9%, 250 mL Bag, USP*	0338-0049-02	12, 24, 36
NaCl, Injection 0.9%, 500 mL Bag, USP*	0338-0049-03	12, 24, 36
NaCl, Injection 0.9%, 250 mL Bag, USP*	0409-7983-02	12, 24, 36
NaCl, Injection 0.9%, 500 mL Bag, USP*	0409-7983-03	12, 24, 36

* Indicates sterile components

Drugs

Drug	Countries
RADIOGENIX SYSTEM	United States

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