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QUALITY CONTROL OF RADIOPHARMACEUTICALS

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atif hussain

on 1 May 2014

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Transcript of QUALITY CONTROL OF RADIOPHARMACEUTICALS

QUALITY CONTROL OF RADIOPHARMACEUTICALS
~purity
*Measurement that ensures

#Involves several specific tests
PHYSICOCHEMICAL TESTS
~Tests that are essential for the determination of the purity
~Test are also performed for the integrity of radio-pharmaceuticals
~Some of these tests are unique for radiopharmaceuticals because they contain radionuclides
QUALITY CONTROL OF RADIO-PHARMACEUTICAL
*They undergo strict quality control measures
~potency
~product identity
~biological saftey
~efficacy
Physical characters
~one should be familiar with the color and state of a pharmaceutical

~A true solution should not contain any particulate matter
~Any deviation from original colour and clarity should be veiwed with concern because it may reflect changes in radiopharmaceuticals that would alter its biologic behaviour
~collidal of aggregate preprations should have a proper size range of particles for a given purpose
PH AND IONIC STRENGTH
*All radio pharmaceuticals should have an appropriate hydrogen ion concentration or PH for their stability and integrity
*Ideal PH of a radio pharmaceuticals should be 7.4
*PH can vary between 2 and 9 beacuse of the high buffer capacity of the blood
*Measured by PH meter
*Radiopharceuticals must also have proper
~Ionic strenght
~isotonicity
~osmolality
in order to be suitable for human administration
`HOw to acheive correct ionic strenght?
*By adding a proper
~Acid
~alkali
~electrolyte
Radionuclidic purity
Defined as:
The fraction of the total radioactivity in the form of the desired radionuclidic present in a radiophrmaceuticals
Impurities aries from:
-Extraneous nuclear reactions due to isotonic impuriies in the target material
-Fission of heavy elements in the reactor
-The undesireable radionuclides may belong to the same element as the desired radionuclide or to a different element
-Impurities can be removed by appropriate chemical methods
-Radionuclidic purity is determined by measuring the
HALf LIVES AND CHARACTERISTICS RADIATIONS
emitted by indiviual radinclides
Radiochemical purity
Defined as:
the fraction of the total radioactivity in the desired chemical form in radiopharmaceuticals
*Radiochemical impurities arise from
~Decomposition due to action of solvent
~Change in temprature,PH,light
~Presence of oxidizing or reducing agents

~The presence of radiochemical impurites in a radiopharmaceutical in a poor quality images due to the high back ground from the surrounding tissue and the blood,and gives unnecassary radiation dose to the patient
*Dcomposition of the labeled compounds by radiolysis depends upon:
~the specific activity of the radioactive material
~the type and energy of the emitted radiations
~the half life of the radionuclide
~Absorbtion of radiations by labeled molecules result in the formation of free radicals with un paired electrons,which in turn leads to further decomposition of other molecules
~A secondary process due to radiolysis produces H2O2 or HO2 from decomposition of water(solvent),which reacts with and ultimately decomposes labeled molecules
~the stability of a compound is time dependent on exposure to light,change in temprature and radiolysis
~the longer a compound is exposed to these conditions,the more it will tend to break down
`How to lessen the degredation of the material?
*substance such as sodium ascorbate,ascorbic acid and sodium sulfite are often added to maintain the stability of radiophrmaceuticals
~some radiopharmaceuticals are stored in the dark under refigration
`Analytical methods used to detect and determine the radiochemical impurities in a given radiopharmaceuticals:
~precipitation
~paper and instant thin layer chromatograpy
~paper or polyclrylamide gel electrophoresis
~ion exchange
~solvent extraction
~high performance liquid chromatography
~distillation
CHEMICAL PURITY
DEFINED AS:
The fraction of the material in the desired chemical form whether or not all of it is in the labeled form
^aluminium is a chemical impurity in the 99m Tc-eluate
^the presence of the slight amount of globulins in the prepration of albumin is indicative of impurities
~the presence of chemical impurity before radio labeling may result in undesirable labeled molecules that may or may not interfare with the diagnostic tests
~undue chemical impurities may also cause a toxic effect

~Purity of radiophrmaceuticals from chemical impurities is often carried out by methods of chemical sepration such as
^precipitation
^solvent extraction
^ion exchange
^ditillation
The amount of radioactivity of a radiopharmaceuticals before dispensing as well as that of each individual dosage before administration to patients must be determined

Radioassay
~these activity determination are carried out by means of an isotope dose callibrator
~According to the NRC regulation the folowing quality control tests must be performed at the frequencies indicated :
Constancy
(daily)
~ the constany test indicated the reproducbility of measurement by a dose callibrator

Accuracy
(at installation,annualy and after repair )
~the accuracy of a dose calibrator is determined by the measuring the activites of at least two long lived refrences sources and comparing the measured activity with the started activity
~the measured activity must agree with the started activity with G10%
Linearity
(at installations,quarterly and after repairs)
~the linearity test indicates the dose calibrator's activity to measure the activity accurately over a wide range of values
geometry
~variation in sample volumes or geometric configuration of the container
(at installations and after repairs)
Measurement of radioactivity
*radioactivity of a radiophrmaceuticals is measured by placing the sample inside the dose callibrator with the appropriate isotope selector setting
*the reading is displayed in appropriate units(curie or becqurel)
Biological
~biological test are carried out essentially to examine
^The stertility
^Apyrogenicity
^Toxicity
of radiophrmaceuticals before human administration
stertility
~sertility indicates the absence of an viable bacteria mico-organisms in a radiopharmaceuticals prepration
~methods of sertility include
^Autoclaving
^membrane filtration
Apyrogenicity
~All radiophrmaceuticals for human administration are required to be pyrogen free
~pyrogens are either polysaccharides or protiens produced by the metabolism of micro-organism
~they are 0.05 to 1 mm in size soluble and heat stable
~Following administration pyrogens produce symptoms of
fever,chills,leukoponia,pain in joints,sweating,headache,dilation of pupils
Pyrogenicity testing
~USP rabbit test
~LAL(limulus amebocyte lyscte)test
~the principle of the test is based the formation of an opaque gel by pyrogens upon incubating the sample with the LAL AT 37C'
~an assay mixture usually consist of 0.1 ml LAL and a test sample at PH 6 to 8
~the reactions takes place within 15 to 60 min after mixing and depend on the concentration of pyrogens
Toxicity
~it is the degree to which a substance can damage an organism
#testing also known as saftey testing is conducted to determine the degree to which a substance can damage a living or non living organism
*record keeping is mandatory for legal reasons as well as for any faulty prepration
RECORD KEEPING
Made by:
*ATIF HUSSAIN (1171)
PRESENTERS:
~ASIM FAROOQ(1154)
~AHMED AMIN(1172)
MAIN POINTS
1-Quality control of radiopharmaceuticals
2-Physicochemical tests
3-Physical characters
4-PH and ionic strength
5-radionuclidic purity
6-Radiochemical purity
7-Chemical purity
8-Radio assay
9-Measurement
10-Biological tests
& Record keeping
Q
u
e
s
t
i
n
tests
Full transcript