Control Method Test for Tenchnetium (99mTc) bicisate

Running Head: Control Method Test for Tenchenetium.
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Control Method Test for Tenchnetium (99mTc) bicisate
Student’s Name
Institution Affiliate

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Scope of the method
For quality control of any chemical, it must be fully examined in the laboratory so that it meets
the right standards. Similarly, Tenchnetium (99mTc) bicisate complex injection has to be
medically examined to ensure that it meets the correct quantity of protein quantity it should
contain. The generator of Tenchnetium (99mTc) should be done first then there are six tests that
should be done.
The first test is breakthrough of MO-99, test of appearance, test for the pH, alumina limit test,
identification test of radionuclides and finally the purity test for radiochemical. Other tests
include text for sterility though not widely spread.
(Reference: OIE Terrestrial Manual (May 2009), Principles and methods of validation of
diagnostic assays for infectious diseases, Chapter 1.1. 4/5,
ww.oie.int.fileadmin/Home/eng/Health_standards/tahm/1.1.04_VALID.pdf)
Apparatus and Reagents
1. <0.15 UCi of Mo-99/mCi of 99mTc

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2. Ascorbic Acid
3. Stannous chloride dehydrate : SnCl22H2O;
4. Sodium hydroxide
5. Water for injection (Nitrogen gas)
6. Hydrochloric acid: HCL(concentrated, 1N, 0.2N);
(Refrence: LGC (2009), In-house method validation- A guide for chemical laboratories,
Laboratory of the Government Chemist (LGC), UK.
Step-by-step sequence of testing operations and procedure;
1. Blood is drawn in up to exactly 0.5mm of the thoma pipette.
2. Clear using a soft wet towel the outside of the thoma pipette to avoid interfering with the
dilution factor.
3. Using your left hand, hold the thoma pipette to an angle almost vertical so that the fluid
spreads evenly in the thoma pipette.
4. Remove the diluting fluid to ensure that the moisture reaches up to the 11 mark. Rotate
the pipette gently for proper missing.
5. Use your index figure to close the opening of the pipette, bend it gently, detach off the
aspirator from the previous end of the pipette and ensure the dilution is complete.
6. Wait for the fluid to settle fully.