Determination of Radiochemical Purity and Pharmacokinetic Parameters of 99mTc-Sulphur Colloid and 99mTc-Tin Colloid

1981 ◽  
Vol 20 (06) ◽  
pp. 279-282 ◽  
Author(s):  
D. Konstantinovska ◽  
K. Milivojević ◽  
J. Bzenić ◽  
V. Jovanović
Keyword(s):  
Radiochemical Purity ◽  
Slow Component ◽  
Pharmacokinetic Parameters ◽  
Optimum Size ◽  
Buffer Solution ◽  
Chromatography Method ◽  
Fast Phase ◽  
Biodistribution Studies ◽  
Biological Half Time

Labelling yield and radiochemical purity, higher than 95%, of 99mTc-colloid preparations were determined by using the paper chromatography method. Less than 3% of labelled citric acid, added to the preparation as a buffer solution, has been found in 99mTc-sulphur colloid. High radiochemical purity and optimum size of colloid particles has also been proved by biodistribution studies on experimental animals. The analysis performed has shown that more than 50% of 99mTc-colloid preparations excreted by urine is 99mTcO–, the remaining past 50% being protein bound 99mTc. Biological half-time of excretion of the fast phase is the same for both preparations, i.e. 10 min, while for the slow component it is 120 min in 99mTc-S-colloid and 160 min in 99mTc-Sn colloid.

scholarly journals Development and Validation of a GMP-Compliant High-Pressure Liquid Chromatography Method for the Determination of the Chemical and Radiochemical Purity of [18F]PSMA-1007, a PET Tracer for the Imaging of Prostate Cancer

2021 ◽  
Vol 14 (3) ◽  
pp. 188
Author(s):  
Ines Katzschmann ◽  
Heike Marx ◽  
Klaus Kopka ◽  
Ute Hennrich
Keyword(s):  
Prostate Cancer ◽  
Quality Control ◽  
Radiochemical Purity ◽  
Control Method ◽  
Solid Phase ◽  
Hplc Method ◽  
Attractive Alternative ◽  
Chromatography Method ◽  
Pet Tracer

For the PET imaging of prostate cancer, radiotracers targeting the prostate-specific membrane antigen (PSMA) are nowadays used in clinical practice. [18F]PSMA-1007, a radiopharmaceutical labeled with fluorine-18, has excellent properties for the detection of prostate cancer. Essential for the human use of a radiotracer is its production and quality control under GMP-compliance. For this purpose, all analytical methods have to be validated. [18F]PSMA-1007 is easily radiosynthesized in a one-step procedure and isolated using solid phase extraction (SPE) cartridges followed by formulation of a buffered injection solution and for the determination of its chemical and radiochemical purity a robust, fast and reliable quality control method using radio-HPLC is necessary. After development and optimizations overcoming problems in reproducibility, the here described radio-HPLC method fulfills all acceptance criteria—for e.g., specificity, linearity, and accuracy—and is therefore well suited for the routine quality control of [18F]PSMA-1007 before release of the radiopharmaceutical. Recently a European Pharmacopeia monograph for [18F]PSMA-1007 was published suggesting a different radio-HPLC method for the determination of its chemical and radiochemical purity. Since the here described method has certain advantages, not least of all easier technical implementation, it can be an attractive alternative to the monograph method. The here described method was successfully validated on several radio-HPLC systems in our lab and used for the analysis of more than 60 batches of [18F]PSMA-1007. Using this method, the chemical and radiochemical purity of [18F]PSMA-1007 can routinely be evaluated assuring patient safety.

Synthesis, radiolabeling and quality control of 111In-DOTA-bevacizumab for radioimmunoscintigraphy of VEGF receptors

2013 ◽  
Vol 101 (9) ◽  
pp. 577-584
Author(s):  
A. Khorami-Moghadam ◽  
A. R. Jalilian ◽  
K. Yavari ◽  
B. Alirezapour ◽  
M. Mazidi ◽  
...  
Keyword(s):  
Radiochemical Purity ◽  
Human Colon ◽  
Vascular Endothelial ◽  
Tumor Uptake ◽  
Wild Type ◽  
Human Colon Cancer ◽  
Biodistribution Studies ◽  
Endothelial Growth Factor

Summary In this study, bevacizumab was successively labeled with 111In-InCl3 after conjugation with DOTA-NHS-ester followed by molecular filtration and determination of the average number ofDOTAconjugated per mAb (6 : 1) by spectrophotometric method. Radiochemical purity (> 97%, measured by ITLC and HPLC), integrity of protein after radiolabeling (gel electrophoresis) and stability of 111In-DOTA-Bevacizumab (in final formulation, human serum, liver/kidney homogenates) were determined in 24-72 h as well as biodistribution studies in wild-type rats and human colon cancer (SW-480) bearing mice. The accumulation of the radiolabeled antibody was consistent with the former reported Bevacizumab conjugates. Significant tumor uptake (8%) was observed at 72 h p.i. Tumor/muscle uptake ratios were 2.6 (24 h), 9.74 (48 h) and 25 (72 h). 111In- DOTA-Bevacizumab was prepared as a SPECT molecular imaging agent for diagnosis and follow-up of vascular endothelial growth factor A (VEGF-A) expression in oncology.

scholarly journals Method Development and Validation of Ion Chromatography Method for Determination of Free Sulfate in Fondaparinux Sodium Pre-Filled Syringe

2020 ◽  
Vol 32 (7) ◽  
pp. 1746-1750
Author(s):  
Kona S. Srinivas ◽  
Mahesh Kalva ◽  
Mallesh Changali ◽  
Narasimha S. L akka
Keyword(s):  
Ion Chromatography ◽  
Flow Rate ◽  
Mobile Phase ◽  
Method Development ◽  
Active Pharmaceutical Ingredient ◽  
Fondaparinux Sodium ◽  
Buffer Solution ◽  
Chromatography Method ◽  
Column Temperature

A simple ion chromatography method was developed for the quantitative determination of free sulfate in fondaparinux sodium pre-filled syringe for injection. Chromatographic separation was achieved on an anion-exchange resin column made of super macro porous polyvinyl benzyl ammonium polymer cross-linked with divinyl benzene (250 × 4.0 mm) with a mobile phase consisting of 60 mM carbonate buffer solution. Conductivity detector was employed with a flow rate of 0.7 mL min-1, injection volume of 100 μL and column temperature of 30 ºC. Retention time of sulfate (SO4 2−) was eluted at about 10.4 min. The developed method was validated in according to ICH Q2(R1) guideline and was found to be specific, precise, accurate, linear and robust. The precision was evaluated with six individual spiked samples of sulfate on Fondaparinux sodium for injection. The proposed method is linear (r2 > 0.9991) and accurate, mean recoveries were 99.2-117.8 % at 3 different levels (50-150%). The robustness was performed by changing the flow rate of mobile phase (0.7 ± 0.1mL min-1) and column temperature (30 ± 2 ºC). The proposed method is capable to determine free sulphate in fondaparinux sodium for injection in presence of excipients used in pharmaceutical formulation and also in its active pharmaceutical ingredient.

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