scholarly journals Development of an HPLC method for the radiochemical purity evaluation of [18F]fluoroestradiol

2019 ◽  
Vol 7 (2A) ◽  
Author(s):  
Ana Carolina De Araujo Bispo ◽  
Leonardo Tafas Constantino Nascimento ◽  
Flávia Mesquita Costa ◽  
Juliana Batista Da Silva ◽  
Marcelo Mamede
Keyword(s):  
Quality Control ◽  
Retention Time ◽  
Radiochemical Purity ◽  
Cell Receptor ◽  
Hplc Method ◽  
Response To Therapy ◽  
Liquid Chromatograph ◽  
Ultraviolet Detectors ◽  
Therapy Strategy ◽  
Positron Emission

18F-Fluoroestradiol ([18F]FES), an estrogen analog, is a radiopharmaceutical used in Positron Emission Tomography (PET) that allows evaluating the tumor cell receptor profile and the best therapy strategy, the staging, the prognosis and the response to therapy in several breast cancer cases. As there is not any pharmacopoeia’s monograph of [18F]FES to standardize its quality control criteria, this work presents a new HPLC’s method to perform the [18F]FES radiochemical purity. A liquid chromatograph was used with radioactivity and ultraviolet detectors. Three concentrations of fluoroestradiol standard solution were used along the test. Their retention time was compared to its relative radiolabelled analogue to confirm its identity. Several mobile phases with acetonitrile and two mobile phase flows were tested to optimize the runs. Peaks symmetry, retention time, theoretical plates and resolution were analyzed to choose the best conditions. The mean retention time of both standard Fluoroestradiol and [18F]FES solutions were the same, demonstrating that [18F]FES formulation did not interfere with [18F]FES analysis. The best conditions were 1.2 mL/min and isocratic 40% V/V acetonitrile in water, which gave [18F]FES peak resolution greater than 6 and symmetry factor of 1. Thus, the developed method is ready to be validated and implemented in [18F]FES quality control routine in CDTN/Brazil.

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.

scholarly journals Synthesis, quality control and dosimetry of the radiopharmaceutical 18F-sodium fluoride produced at the Center for Development of Nuclear Technology - CDTN

2010 ◽  
Vol 46 (3) ◽  
pp. 563-569 ◽  
Author(s):  
Marina Bicalho Silveira ◽  
Marcella Araugio Soares ◽  
Eduardo Sarmento Valente ◽  
Samira Soares Waquil ◽  
Andréa Vidal Ferreira ◽  
...  
Keyword(s):  
Quality Control ◽  
Sodium Fluoride ◽  
Radiochemical Purity ◽  
Nuclear Technology ◽  
Physical Chemical ◽  
Positron Emission ◽  
Oncological Diseases ◽  
Pet Scans ◽  
Quality Imaging ◽  
The U.S

18F-Sodium fluoride (Na18F) is a radiopharmaceutical used for diagnosis in nuclear medicine by positron emission tomography (PET) imaging. Bone scintigraphy is normally performed using 99mTc-MDP. However, 18F PET scans promise high quality imaging with increased resolution and improved sensitivity and specificity. In order to make available a tool for more specific studies of tumors and non-oncological diseases of bone tissue, the UPPR/CDTN team undertook the production and quality control of Na18F injectable solution with the physical-chemical, microbiological and biological characteristics recommended in the U.S. Pharmacopeia. Na18F radiochemical purity was 96.7 ± 1.3 %, with Rf= 0.026 ± 0.006. The product presented a pH of 5.3 ± 0.6, half life of 109.0 ± 0.8 minutes, endotoxin limit < 5.0 EU.mL-1 and no microbial contaminants. The biodistribution of Na18F was similar to that described in the literature, with a clearance of 0.19 mL.min-1 and distribution volume of 18.76 mL. The highest bone concentration (5.0 ± 0.5 %ID.g-1) was observed 20 minutes after injection. Na18F produced at the UPPR presented all the quality assurance requirements of the U.S. Pharmacopeia and can be safely used for clinical bone imaging.

scholarly journals Analytical procedure for quality control of 18F-Choline radiopharmaceutical

2021 ◽  
Vol 63 (5) ◽  
pp. 10-16
Author(s):  
Thanh Quang Vu ◽  
◽  
Ngoc Khoan Ha ◽  
Thanh Rin Bui ◽  
Trung Dung Nguyen ◽  
...  
Keyword(s):  
Quality Control ◽  
High Performance ◽  
Radiochemical Purity ◽  
Analytical Procedure ◽  
Hplc Method ◽  
Central Hospital ◽  
Residual Solvents ◽  
Quality Specifications ◽  
Pet Radiopharmaceutical ◽  
Required Quality

18Fluoromethylcholine (18F-Choline, 18F-FCH) has been produced using a home-made automatic synthesiser at 30 MeV Cyclotron Centre, 108 Military Central Hospital. In order to be licensed using for patients, the 18F-FCH radiopharmaceutical needs to meet the required quality specifications listed in the pharmacopeia. The objective of this study was to build up the analytical procedure and to perform for the 18F-FCH quality control followed the EuPh2017 pharmacopeia for the PET radiopharmaceutical. The result obtained confirmed that the total time to complete the test of one sample of the 18F-FCH was less than 35 min. Identifications of 18F-FCH, radiochemical purity, and 18F content were determined with accuracy >96% by High-performance liquid chromatography (HPLC) method and content of residual solvents consists of Ethanol, Acetonitrile, Dibromomethane, Dimethylethanolamine were determined with the accuracy >97% by Gas chromatography (GC) method.

scholarly journals Fundamental concepts of radiopharmaceuticals quality controls

2019 ◽  
Author(s):  
Sajjad Molavipordanjani ◽  
Seyed Jalal Hosseinimehr
Keyword(s):  
Quality Control ◽  
Radiochemical Purity ◽  
Diagnostic Information ◽  
Emission Tomography ◽  
High Background ◽  
Radiation Burden ◽  
Biodistribution Studies ◽  
Positron Emission ◽  
Bacterial Endotoxins ◽  
Unnecessary Radiation

Quality control (QC) procedures should always be performed following radiopharmaceutical preparation and prior to patient administration. The main aim of QC is to ensure optimal radiopharmaceutical product properties except for some short half-life tracers such as some positron emission tomography (PET) imaging probs. by dispensing a radiopharmaceutical of the highest quality the risk of having to repeat a nuclear medicine study due to poorly performing radiopharmaceuticals will be reduced. The existence of radiochemical impurity or impurities in radiopharmaceutical cause unnecessary radiation burden to the patient or undesirable high background without adding to the diagnostic information or improving treatment. Therefore, radiopharmaceuticals quality control is crucial and involves two different aspects including pharmaceutical parameters (such as sterility, bacterial endotoxins/ pyrogens, bioaffinity and biodistribution studies) and radioactive parameters (such as radionuclide and radiochemical purity) and chemical impurity which will be focused on here.

Physiological Animal Imaging with 68Ga-Citrate

2020 ◽  
Vol 13 ◽  
Author(s):  
Uğur Ayşe ◽  
Gültekin Aziz
Keyword(s):  
Quality Control ◽  
Animal Studies ◽  
Radiochemical Purity ◽  
Standard Procedure ◽  
Blood Pool ◽  
Hplc Method ◽  
Uptake Mechanism ◽  
Animal Imaging ◽  
Definition Of ◽  
Gallium 68

: Gallium-68 is an ideal research and hospital-based PET radioisotope. The uptake mechanism of Gallium citrate is a combination of specific and non-specific processes, for example, vasodilatation, increased vascular permeability, plasma transferrin binding and lactoferrin and siderophores. In this study, by applying the 68Ge/68Ga generator product, a simple technique for the synthesis and quality control of 68Ga-citrate was introduced and was followed by preliminary animal studies. The synthesis of 68Ga-citrate was performed with a cationic method using the Scintomics automated synthesis system (Scintomics GmbH GRP module 4V). Since the standard procedure for quality control (QC) was not available, the definition of chemical and radiochemical purity of 68Ga-citrate was carried out according to the ICH Q2(R1) guideline. The standard QC tests were analysed with Scintomics 8100 radio-HPLC system equipped with a radioactivity detector. In this study, a New Zealand rabbit weighing 2520 g was used for PET/CT images. 68Ga-citrate synthesis was performed by a cationic method without using organic solvents. The labelling efficiency was found to be >98%. The HPLC method used to assess the radiochemical purity of 68Ga -citrate was validated as rapid, accurate and reproducible enough to apply it to patients safely. The physiological distribution of 68Ga-citrate was investigated in a healthy rabbit. The blood pool, liver, spleen, kidneys and growth plates were the most common sites of 68Ga-citrate involvement.

scholarly journals DEVELOPMENT OF THE METHODOLOGY OF THE CHROMATOGRAPHIC DETERMINATION OF NIFEDIPINE IN MEDICINES

2017 ◽  
Vol 10 (3) ◽  
pp. 149 ◽  
Author(s):  
Liliya Logoyda ◽  
Dmytro Korobko ◽  
Serhii Kovalenko ◽  
Iryna Ivanusa
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Retention Time ◽  
High Performance ◽  
Chromatographic Determination ◽  
Hplc Method ◽  
Liquid Chromatograph ◽  
Relative Standard ◽  
Label Claim

ABSTRACTObjective: The aim was to develop a simple, rapid, less expensive, linear, precise, and accurate reverse phase high performance liquid chromatographymethod for determination of nifedipine in tablets.Methods: The chromatographic analysis of nifedipine was performed using liquid chromatograph Agilent 1290 Infinity II LC System. Selectedconditions were isocratic elution with binary mobile phase consisting of solution methanol and 0.1% trifluoroacetic acid (55:45). Detection wascarried out using spectrophotometric detector at 265 nm. The method was validated as per ICH guidelines.Results: The retention time for nifedipine by proposed high performance liquid chromatography (HPLC) method is observed as 3.5 minutes. Thecorrelation coefficients are 1.0000. The developed chromatographic method was found to be accurate with recovery 99.2-99.8% and was foundwithin the acceptance criteria (i.e. 98.0-102.0%) with acceptable % relative standard deviation of not more than 2% at each level. The assay results ofnifedipine in tablets by developed method are highly reproducible, reliable and are in good agreement with the label claim of the medicines (average99.62 %).Conclusion: Finally, it should be noted that a new simple, rapid, linear, precise, accurate HPLC method was developed and validated for thedetermination of nifedipine in medicines in accordance with the ICH guidelines. These results show the method are accurate, precise, sensitive,economic, and rugged. The proposed HPLC method is rapider (retention time is 3.5 minutes). This method can be useful for the routine analysis ofnifedipine in pharmaceutical dosage form.Keywords: Nifedipine, High-performance liquid chromatography, Validation, Linearity, Accuracy, Range of application.

Development of an HPLC method for quality control of Alpinia zerumbet

Planta Medica ◽  
2013 ◽  
Vol 79 (13) ◽  
Author(s):  
I Cardoso ◽  
M Tappin ◽  
M Nakamura ◽  
H Pereira ◽  
M Behrens
Keyword(s):  
Quality Control ◽  
Hplc Method ◽  
Alpinia Zerumbet

Chemical Fingerprint Analysis and Simultaneous Determination of Nucleosides and Amino Acids in Kang Fu Xin Liquid by High Performance Liquid Chromatography with Diode Array Detector

2020 ◽  
Vol 16 (7) ◽  
pp. 831-843
Author(s):  
Yuwen Wang ◽  
Shuping Li ◽  
Liuhong Zhang ◽  
Shenglan Qi ◽  
Huida Guan ◽  
...  
Keyword(s):  
Amino Acids ◽  
Quality Control ◽  
Uric Acid ◽  
Control Method ◽  
Principal Component ◽  
Gradient Elution ◽  
Hplc Method ◽  
Array Detector ◽  
Fingerprint Analysis ◽  
Wavelength Switching

Background and Objective: Kang Fu Xin liquid (KFX) is an official preparation made from the ethanol extract product from P. Americana. The present quality control method cannot control the quality of the preparation well. The aim of the present study is to establish a convenient HPLC method for multicomponents determination combined with fingerprint analysis for quality control of KFX. Methods: An HPLC-DAD method with gradient elution and detective wavelength switching program was developed to establish HPLC fingerprints of KFX, and 38 batches of KFX were compared and evaluated by similarity analysis (SA), hierarchical clustering analysis (HCA), and principal component analysis (PCA). Meanwhile, six nucleosides and three amino acids, including uracil, hypoxanthine, uric acid, adenosine, xanthine, inosine, tyrosine, phenylalanine and tryptophan in KFX were determined based on the HPLC fingerprints. Results: An HPLC method assisted with gradient elution and wavelength switching program was established and validated for multicomponents determination combined with fingerprint analysis of KFX. The results demonstrated that the similarity values of the KFX samples were more than 0.845. PCA indicated that peaks 4 (hypoxanthine), 7 (xanthine), 9 (tyrosine), 11, 13 and 17 might be the characteristic contributed components. The nine constituents in KFX, uracil, hypoxanthine, uric acid, adenosine, xanthine, inosine, tyrosine, phenylalanine and tryptophan, showed good regression (R2 > 0.9997) within test ranges and the recoveries of the method for all analytes were in the range from 96.74 to 104.24%. The limits of detections and quantifications for nine constituents in DAD were less than 0.22 and 0.43 μg•mL-1, respectively. Conclusion: The qualitative analysis of chemical fingerprints and the quantitative analysis of multiple indicators provide a powerful and rational way to control the KFX quality for pharmaceutical companies.

Influence of Baseline Positron Emission Tomography in Metastatic Gastroesophageal Cancer on Survival and Response to Therapy

Oncology ◽  
2021 ◽  
pp. 1-6
Author(s):  
Ahmed Abdelhakeem ◽  
Madhavi Patnana ◽  
Xuemei Wang ◽  
Jane E. Rogers ◽  
Mariela Blum Murphy ◽  
...  
Keyword(s):  
Positron Emission Tomography ◽  
Response To Therapy ◽  
Emission Tomography ◽  
Gastroesophageal Cancer ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Positron Emission ◽  
Pet Ct ◽  
Metastatic Burden

<b><i>Background:</i></b> The value of baseline fluorodeoxyglucose-positron emission tomography-computed tomography (PET-CT) remains uncertain once gastroesophageal cancer is metastatic. We hypothesized that assessment of detailed PET-CT parameters (maximum standardized uptake value [SUVmax] and/or total lesion glycolysis [TLG]), and the extent of metastatic burden could aid prediction of probability of response or prognosticate. <b><i>Methods:</i></b> We retrospectively analyzed treatment-naive patients with stage 4 gastroesophageal cancer (December 2002–August 2017) who had initial PET-CT for cancer staging at MD Anderson Cancer Center. SUVmax and TLG were compared with treatment outcomes for the full cohort and subgroups based on metastatic burden (≤2 or &#x3e;2 metastatic sites). <b><i>Results:</i></b> We identified 129 patients with metastatic gastroesophageal cancer who underwent PET-CT before first-line therapy. The median follow-up time was 61 months. The median overall survival (OS) was 18.5 months; the first progression-free survival (PFS) was 5.5 months. SUVmax or TLG of the primary tumor or of all metastases combined had no influence on OS or PFS, whether the number of metastases was ≤2 or &#x3e;2. Overall response rates (ORRs) to first-line therapy were 48% and 45% for patients with ≤2 and &#x3e;2 metastases, respectively (nonsignificant). ORR did not differ based on low or high values of SUVmax or TLG. <b><i>Conclusions:</i></b> This is the first assessment of a unique set of PET-CT data and its association with outcomes in metastatic gastroesophageal cancer. In our large cohort of patients, detailed analyses of PET-CT (by SUVmax and/or TLG) did not discriminate any parameters examined. Thus, baseline PET-CT in untreated metastatic gastroesophageal cancer patients has limited or no utility.

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