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To determine the radiochemical purity of the following techniques may be used chromatography paper

thin layer: TLC, ITLC (technetium radiopharmaceuticals, 111In and 90Y-Zevalin
gas chromatography
HPLC can identify species that can not otherwise identifiable as antibodies, peptides, etc..

The great success of 99mTc scintigraphy in the investigation is explained mainly due to:

production costs acceptable (though we are witnessing today a reorganization planetarium production downward by central technetium Nuclear)
or half-life T1 / 2 of approximately 6 hours (6, O22 h)
emergy emission peak at 140 keV
optimal oxidative status from -1 to +7 with large possibility of manipulation. Little used, however, is the pertechnetate (Tco4) as well as just "milked" from a 99Mo generator.

99mTc, therefore, obtained from the generator, and is in the form of sodium pertechnetate (Tco4) is used for the marking of lyophilized kits containing the molecule to be marked. E 'for the most part added tin chloride (SnCl2) as a reducing agent that brings the 99mTc oxidation state +7 to that required for the marking of the molecule, so by putting like symbols respectively R (reducing) and (W) binding we observe the following reaction:

99mTcO4 + R + L = 99m (L) n

It 'possible that the reaction resulting in a complex dynamic following of all impurities which contribute to hinder, if not to compromise more or less obvious quality scintigraphic investigation. In some rare cases indeed, may be able to attend the diagnostic investigation impossible. Impurities are

so-called free technetium Tc (TCo4) that accumulates the salivary glands, thyroid and stomach mainly.
Tc reduced, but linked, hydrolyzed passing through the reticuloendothelial system and it is stressed in the liver, spleen etc.
denatured molecules labeled with Tc as fragments, polymers, etc..

The chromatographic technique recognized as the most accurate is the HPLC but has tamp long run. E 'therefore necessary to undertake quality control of radiochemical purity of technetium radiopharmaceuticals by TLC (Thin Layer Chromatography) and ITLC (Instant Thin Layer Chromatography). The ITLC TCL differed by only small size of paper plates.

In both cases must be deposited in the 'so-called area origin of the map provided in commercial kits purchased from the company dedicated OMNIA of Urbino, a minimum of a few microliters of the sample, in our case the radiopharmaceutical technetium MDP. On the opposite side of the 'home area that is visible solvent front.

tests require the placement of rate of ca. 10 microliters of sample on a strip radiocromatografica radiopharmaceutical.

on one side of each strip of the test are easily visible from two indelible black lines, a bottom (origin) is the storage area of \u200b\u200bthe commercial sample of radiopharmaceutical and the other, upper (solvent front) the terminal point of the process. A gradient of color shows the advancing solvent front from pole to pole of the strip. A color identifies the different uses of each strip.

E 'by this method can then determine the percentage of free pertechnetate, a radiopharmaceutical perdentuale of marked and the percentage of hydrolyzed-reduced 99mTc. NB

the decision to use the preparation after the test is the responsibility of NM (nuclear medicine).

Kit BIODEX by OMNIA

OM-

152-110 :
Nano colloid, colloid Shulfur, MAA DTPA, MDP, HDP , pyrophosphate, Diphosphonate, Gucoheptonate kits.

determining the percentage of free technetium:

Prepare the vial of development (red label) by adding 1 cc of solvent called "Red Acetone.
Apply a strip of chromatographic red drop of about 10 microliters of the sample to be tested below the indelible black posizionatanelal bottom of the strip.

immediately place the test strip into the vial labeled red which contains the previously prepared acetone and allow the event to develop until the solvent front to migrate above the black line is visible nelal the top of the strip.
Remove the strip from the vial and let it dry.
Lay the strip using forceps between two sheets of cellophane.
Observe the plate with the flexible allocation of Cyclone plus Perkin Elmer Company, in light of a view box for one minute so as to eliminate possible traces of past exposure and possible controls that are effective calcellazioni made via quick scan with the Cyclone plus.
Place the sensitive part of the slide on the ground prepared for about ten seconds. so impressed with the manner and place it in the correct Cyclone for scanzione.
Soon will appear on the display of the Cyclone Plus' refers to the radiographic image esposizioini we produce ready to be processed by placing ROI that date will be processed by the program that will display on screen and in print the results.

The species most frequently found in a total of radiopharmaceutical are three:

hydrolyzed 99mTc (I)
free 99mTc pertechnetate (L)
radiopharmaceutical 99mTc-related (R)

checks are often performed for the two objective difficulties in the separation of impurities (I) and (L) from the radiopharmaceutical (R). Considering also that the radiopharmaceutical (R) has a Rf (relative front) differently depending on whether you are using as mobile phase acetone or saline.

Fig.1)

E 'can thus calculate the percentage of (I) hydrolyzed 99mTc since this procedure is still at the point of origin where it was placed just before the spot of radiopharmaceutical labeled . The following formula allows us to know the percentage of (I) as just expressed.

I (%) = (I / (R + I + L) * 100)

Fig.2)

In the latter case Acetone is used that allows the percentage of so-called calcorare 99mTc pertechnetate that free technetium (L) only compound to migrate instead undergo a stop to the origin is the radiopharmaceutical (R) technetium (I) 99mTc hydrolyzate.

L (%) = (L / (R + I + L) * 100)

It 'now possible to calculate the percentage difference of radiopharmaceutical labeled (R):

R (%) = 100 - I (%) - L (%)

Kit BIODEX by OMNIA

OM-151-970

MYOVIEW (99mTc tetrofosmin)

Myoview The product is a radiopharmaceutical for myocardial perfusion study indicated that additional diagnostic tool in the diagnosis and localization of ischemia and / or myocardial infarction. In patients undergoing scintigraphy for the study of myocardial perfusion, ECG-gated SPECT technique can be used to evaluate left ventricular function that is, ejection fraction (EF) and Left-ventricular wall motility.

the initial distribution of 99mTc-tetrafosmina is proportional to the regional coronary blood flow and rapidly cleared after intravenous injection of 66% are removed within 48 hours after injection in the 40% approximately. eliminated for the urine and feces for about the remaining 26%. extraction is approximately 50-65%. The scintigraphic imaging of coronary blood flow is descriptive as well as objectively looks at the time of administration, any changes in the flow can be detected only after a new re-injection.

Implementation of Quality Control (QC)

pay the 35:65 mixture of acetone in dichloro methane tank for chromatography to a height 1 cm and cover to allow the solvent evaporated to reach a balance.
mark a paper strip ITLC / LG with a pencil a 3cm from the bottom, and a pen with indelible ink to mark another line at 15cm from the previous year. The pencil line indicates where the sample must be dopositato color and distance from the line to indicate the position of the ink solvent front at the end of the operation at the end of elution. Biodex In our case, the kit provides all the material including strips of paper already printed the reference areas.
pencil to mark two points of reference to 3cm and 12cm from the source, respectively, equal to Rf to 0.2 and 0.8.
with 1 ml syringe with 22 to 25 August G aplica a sample of about 10 -20 microliters of injectable preparation at 'home of the strip. We need to prevent the stain dries. Place the strip immediately to the chromatography tank and cover. Make sure that the strip does not stick to the sides of the pan. Note that a sample of 10-20 microliters produce a spot diameter of 7-10 mm. It was noted that samples volumetrically minor damage inaccurate values \u200b\u200bof radiochemical purity.
When the solvent reaches the ink line (solvent front), remove the strip from the tank and let dry.
cut the strip into 3 pieces at the marked locations and measure the activity of each unit using suitable counting. In our case we use Cyclone Plus the Perkin Elmer Company it is flexible enough to impress the media that came with the radioactivity emitted from the strip in a manner described further.
Calculate the radiochemical purity using the following formula: