Quality Control Tests Research Articles

Trace level quantification of N-nitrosorasagiline in rasagiline tablets by LC-TQ-MS/MS

Parkinson's disease is a chronic, progressive neurological disease that currently affects about more than 10 million population worldwide. Rasagiline is a selective, irreversible monoamine oxidase type B inhibitor used as monotherapy in early Parkinson's disease. Rasagiline tablets have been recalled from market due to the presence of unacceptable levels of nitrosamine impurity. European Medical Agency has set up very stringent limit 100ng/day of N-nitrosorasagiline (NSRG) in drug product based on its mutagenicity. The analytical methods need to be sufficiently sensitive in order to adequately detect and quantify trace levels of NSRG. A highly sensitive LC-MS/MS method for determination of NSRG in rasagiline tablet formulation was developed by effectively separating on zorbax eclipse XDB C18 column using 0.1% formic acid in mixture of water and acetonitrile (35:65 v/v) in an isocratic mode at 0.5mL/min flow rate. The measurement of NSRG was performed using triple quadrupole mass detection accompanied by electrospray ionization in the multiple reaction monitoring mode. The validation of the method was comprehensive, demonstrating strong linearity across the concentration spectrum of 2 to 200ng/mL for NSRG. The obtained correlation coefficient exceeded 0.998, signifying a robust relationship. Recoveries spanning from 80.0% to 120.0% for NSRG were deemed satisfactory. The developed method was able to detect and quantitate NSRG at a concentration level of 1 to 2ng/mL respectively (1 to 2ppm with respect to 1mg/mL of rasagiline tablet sample concentration). The developed and validated method can be employed for routine quality control testing of rasagiline tablets.

Comparison of microscopy and quality control testing to examine the durability of adhesive bondline in cross-laminated timber

Adhesive bonding quality significantly contributes to the integrity and quality of cross-laminated timber (CLT). There are several factors affecting bonding quality in glued-layered wood products such as CLT that are generally categorized as the properties of wood, adhesive type and curing conditions. The adhesive bonding performance of five different types of CLTs made from yellow-poplar and southern pine lumber using phenol-resorcinol formaldehyde and polyurethane structural adhesives were studied using light microscopy and ANSI/APA PRG-320 mechanical evaluation tests. The results show that CLTs with a thin bondline and the highest effective penetration had the highest shear strength, and with least face delamination. The effect of wood anatomy on bonding quality was demonstrated in mixed species CLT with different penetrations into different species. The effect of adhesive curing was observed through the presence of generating gaps and microbubbles in adhesive lines.

Quality control and external quality assessment for the independent clinic-based evaluation of point-of-care testing to detect Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis in eight countries

BackgroundSexually transmitted infections caused by Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) remain significant global health problems. The World Health Organization (WHO) has recently conducted a multi-faceted, multi-country validation study (ProSPeRo), which included an evaluation of the Xpert CT/NG and Xpert TV assays on the GeneXpert system (Cepheid, Sunnyvale, Ca., USA) in clinic-based settings across eight countries. To support the study, a training and quality management system was implemented and evaluated.MethodsA comprehensive training program for the study was developed. Quality control (QC) and external quality assessment (EQA) samples were provided by an accredited quality assurance provider. QC testing was conducted at 14 point-of-care testing (POCT) clinics, while EQA samples were tested by the POCT sites and a reference laboratory supporting each clinic.ResultsFor QC testing, concordance with the expected results for CT and NG was > 99% and rates of unsuccessful tests were < 4%. For TV testing, concordance was similar (97%), but rates of unsuccessful tests were high (18%), particularly in the ‘TV negative’ sample. For EQA testing initially conducted in 2018, concordance was 100% for CT and NG, and 90% for TV for the reference laboratory group (which used non-GeneXpert systems). Concordance for the POCT group was also high (> 94%) for all analytes, but this cohort (which used GeneXpert systems) exhibited a high rate of unsuccessful TV tests. All but one of these unsuccessful tests was subcategorised as ‘invalid’.ConclusionsThe high level of concordance for QC and EQA testing confirm that the trained operators at the POC clinical sites were competent to conduct POC testing and that the training and quality systems implemented for the ProSPeRo study were effective. The quality materials used were satisfactory for CT and NG but exhibited poor performance for TV testing on the GeneXpert system. The WHO should continue to work with industry and EQA providers to provide improved materials that are reliable, stable and cost effective for quality management, as it seeks to rollout molecular-based STI POCT in non-laboratory-based settings.Trial registrationEthics approval to conduct the ProSPeRo study was granted by the WHO Ethics Review Committee.

External proficiency testing for histocompatibility and immunogenetics in today and future.

The Histocompatibility and Immunogenetics laboratories provide disease association and pharmacogenetic analyses as well as the tests required for transplantation immunology and transfusion medicine. They perform Human Leukocyte Antigen (HLA) genotyping in patients/recipients and potential donor candidates for solid organ and stem cell transplants using various molecular methods, and determine mismatches. In addition, they also perform HLA antibody tests to detect anti-HLA antibodies in patients and flow cross-matches to evaluate donor-recipient compatibility. Evidence-based clinical guidelines have emphasized the importance of laboratory tests in clinical practices for a long time. Understanding the principles of Quality Control and External Quality Assurance is a fundamental requirement for the effective management of Tissue Typing laboratories. When these processes are effectively implemented, errors in routine assays for transplantation are reduced and quality is improved. In this review, the importance of Quality Assurance, Quality control and proficiency testing in Histocompatibility and Immunogenetic testing, the necessity of external proficiency testing (EPT) for accreditation, and existing and potential EPT programmes will be reviewed and evaluated in the light of the literature.

A single-institution experience with 177Lu RPT workflow improvements and qualifying the SPECT/CT imaging for dosimetry.

Implementing any radiopharmaceutical therapy (RPT) program requires a comprehensive review of system readiness, appropriate workflows, and training to ensure safe and efficient treatment delivery. A quantitative assessment of the dose delivered to targets and organs at risk (OAR) using RPT is possible by correlating the absorbed doses with the delivered radioactivity. Integrating dosimetry into an established RPT program demands a thorough analysis of the necessary components and system fine-tuning. This study aims to report an optimized workflow for molecular radiation therapy using 177Lu with a primary focus on integrating patient-specific dosimetry into an established radiopharmaceutical program in a radiation oncology setting. We comprehensively reviewed using the Plan-Do-Check-Act (PDCA) cycle, including efficacy and accuracy of delivery and all aspects of radiation safety of the RPT program. The GE Discovery SPECT/CT 670DR™ system was calibrated per MIM protocol for dose calculation on MIM SurePlan™ MRT software. Jaszcak Phantom with 15-20 mCi of 177Lu DOTATATE with 2.5 µM EDTA solution was used, with the main energy window defined as 208 keV ±10% (187.6 to 229.2 keV); the upper scatter energy window was set to 240 keV ±5% (228 to 252 keV), while the lower scatter energy window was 177.8 keV ±5% (168.9 to 186.7 keV). Volumetric quality control tests and adjustments were performed to ensure the correct alignment of the table, NM, and CT gantry on SPECT/CT. A comprehensive end-to-end (E2E) test was performed to ensure workflow, functionality, and quantitative dose accuracy. Workflow improvements and checklists are presented after systematically analyzing over 400 administrations of 177Lu-based RPT. Injected activity to each sphere in the NEMA Phantom scan was quantified, and the MIM Sureplan MRT reconstruction images calculated activities within ±12% of the injected activity. Image alignment tests on the SPECT/CT showed a discrepancy of more than the maximum tolerance of 2.2 mm on any individual axis. As a result of servicing the machine and updating the VQC and COR corrections, the hybrid imaging system was adjusted to achieve an accuracy of <1 mm in all directions. Workflows and checklists, after analysis of system readiness and adequate training for staff and patients, are presented. Hardware and software components for patient-specific dosimetry are presented with a focus on hybrid image registration and correcting any errors that affect dosimetric quantification calculation. Moreover, this manuscript briefly overviews the necessary quality assurance requirements for converting diagnostic images into dosimetry measurement tools and integrating dosimetry for RPT based on 177Lu.

An Analytical Target Profile for the Development of an In Vitro Release Test Method and Apparatus Selection in the Case of Semisolid Topical Formulations.

This study focuses on how to define an Analytical Target Profile (ATP) which is intended for use in practice and on facilitating the selection of in vitro release test (IVRT) technology for diclofenac sodium topical hydrogel and cream. The implementation involves incorporating the new draft guidelines of the International Council for Harmonisation (ICH Q14) and USP (United States Pharmacopeia) Chapter 1220. Four IVRT apparatuses were compared (USP Apparatus II with immersion cell, USP Apparatus IV with semisolid adapter, static vertical diffusion cell, and a new, in-house-developed flow-through diffusion cell) with the help of the ATP. Performance characteristics such as accuracy, precision, cumulative amount released at the end of the IVRT experiment, and robustness were investigated. We found that the best apparatus for developing IVRT quality control (QC) tests in both cases was USP II with an immersion cell. All four different IVRT apparatuses were compared with each other and with the data found in the literature.

Potency assay to predict the anti-inflammatory capacity of a cell therapy product for macrophage-driven diseases: overcoming the challenges of assay development and validation

BackgroundGiven the high level of product complexity and limited regulatory guidance, designing and implementing appropriate potency assays is often the most challenging part of establishing a quality control testing matrix for a cell-based medicinal product. Among the most elusive tasks are the selection of suitable read-out parameters, the development of assay designs that most closely model the pathophysiological conditions, and the validation of the methods. Here we describe these challenges and how they were addressed in developing an assay that measures the anti-inflammatory potency of mesenchymal stromal cells (MSCs) in an M1 macrophage-dominated inflammatory environment. MethodsAn in vitro inflammation model was established by coculturing skin-derived ABCB5+ MSCs with THP-1 monocyte-derived M1-polarized macrophages. Readout was the amount of interleukin 1 receptor antagonist (IL-1RA) secreted by the MSCs in the coculture, measured by an enzyme-linked immunosorbent assay. ResultsIL-1RA was quantified with guideline-concordant selectivity, accuracy and precision over a relevant concentration range. Consistent induction of the macrophage markers CD36 and CD80 indicated successful macrophage differentiation and M1 polarization of THP-1 cells, which was functionally confirmed by release of proinflammatory tumor necrosis factor α. Testing a wide range of MSC/macrophage ratios revealed the optimal ratio for near-maximal stimulation of MSCs to secrete IL-1RA, providing absolute maximum levels per individual MSC that can be used for future comparison with clinical efficacy. Batch release testing of 71 consecutively manufactured MSC batches showed a low overall failure rate and a high comparability between donors. ConclusionsWe describe the systematic development and validation of a therapeutically relevant, straightforward, robust and reproducible potency assay to measure the immunomodulatory capacity of MSCs in M1 macrophage-driven inflammation. The insights into the challenges and how they were addressed may also be helpful to developers of potency assays related to other cellular functions and clinical indications.

Advancements in Microfluidic Cassette-Based iMiDEV™ Technology for Production of L-[11C]Methionine and [11C]Choline.

Microfluidic technology is a highly efficient technique used in positron emission tomography (PET) radiochemical synthesis. This approach enables the precise control of reactant flows and reaction conditions, leading to improved yields and reduced synthesis time. The synthesis of two radiotracers, L-[11C]methionine and [11C]choline, was performed, using a microfluidic cassette and an iMiDEVTM module by employing a dose-on-demand approach for the synthesis process. We focused on optimizing the precursor amounts and radiosynthesis on the microfluidic cassette. L-[11C]methionine and [11C]choline were synthesized using a microreactor filled with a suitable resin for the radiochemical reaction. Trapping of the [11C]methyl iodide, its reaction, and solid-phase extraction purification were performed on a microreactor, achieving radiochemical yields of >80% for L-[11C]methionine and >60% for [11C]choline (n = 3). The total synthesis time for both the radiotracers was approximately 20 min. All quality control tests complied with the European Pharmacopeia standards. The dose-on-demand model allows for real-time adaptation to patient schedules, making it suitable for preclinical and clinical settings. Precursor optimization enhanced the cost efficiency without compromising the yield. The importance of dose-on-demand synthesis and optimized precursor utilization to produce L-[11C]methionine and [11C]choline was emphasized in this study. The results demonstrated the feasibility of dose-on-demand adaptations for clinical applications with reduced precursor quantities and high radiochemical yields.

An Investigation of Cerebral Vascular Functional Properties in Middle-to-Old Age Community People With High Vascular Risk Profiles.

Vascular degeneration is an important cause of brain damage in aging. Assessing the functional properties of the cerebral vascular system may aid early diagnosis and prevention. To investigate the relationships between potential vascular functional markers and vascular risks, brain parenchymal damage, and cognition. Retrospective. Two hundred two general community subjects (42-80 years, males/females: 127/75). 3 T, spin echo T1W/T2W/FLAIR, resting-state functional MRI with an echo-planar sequence (rsfMRI), pseudo-continuous arterial spin labeling (pCASL) with a three-dimensional gradient-spin echo sequence. Cerebral blood flow (CBF) in gray matter calculated using pCASL, blood transit times calculated using rsfMRI, and the SD of internal carotid arteries signal (ICAstd) calculated using rsfMRI; visual assessment for lacunes; quantification of white matter hyperintensity volume; permutation test for quality control; collection of demographic and clinical data, Montreal Cognitive Assessment, Mini-Mental State Examination. Kolmogorov-Smirnov test; Spearman rank correlation analysis; Multivariable linear regression analysis controlling for covariates; The level of statistical significance was set at P < 0.05. Age was negatively associated with ICAstd (β = -0.180). Diabetes was associated with longer blood transit time from large arteries to capillary bed (β = 0.185, adjusted for age, sex, and intracranial volume). Larger ICAstd was associated with less presence of lacunes (odds ratio: 0.418, adjusted for age and sex). Higher gray matter CBF (β = 0.154) and larger ICAstd (β = 0.136) were associated with better MoCA scores (adjusted for age, sex, and education). Prolonged blood transit time, decreased ICAstd, and diminished CBF were associated with vascular dysfunction and cognitive impairment. They may serve as vascular functional markers in future studies. 3 TECHNICAL EFFICACY: Stage 3.

Channelized hotelling observer-based low-contrast detectability on the ACR CT accreditation phantom: Part II. Repeatability study.

Objective and quantitative evaluation for low-contrast detectability that correlates with human observer performance is lacking for routine CT quality control testing. Channelized Hotelling observer (CHO) is considered a strong candidate to fill the need but has long been deemed impractical to implement due to its requirement of a large number of repeated scans in order to provide accurate and precise estimates of index of detectability (d'). In our previous work, we optimized a CHO model observer on the American College of Radiology (ACR) CT accreditation phantom and achieved accurate measurement of d' with only 1-3 repeat scans. In this work, we aim to validate the repeatability of the proposed CHO-based low-contrast evaluation on four scanner models using the ACR CT accreditation phantom. The repeatability test was performed on four different scanners from two major CT manufacturers: Siemens Force and Alpha; Canon Prism and Prime SP. An ACR CT phantom was scanned 10 times, each time after repositioning of the phantom. For each repositioning, 3 repeated scans were acquired at 24, 12, and 6 mGy on all four scanner models. CHO was applied at the measured dose levels for different low-contrast object sizes (4-6mm). The CHO was also applied to images created using deep learning-based reconstructions on Canon Prism and to four different scan/reconstruction modes on the Siemens Alpha, a photon-counting-detector (PCD)-CT. The repeatability was evaluated by the probability that a measurement would fall within the±15% tolerance (P<15% ). With the CHO setting optimized for the ACR phantom and the use of 3 repeated scans and 9 non-overlapping slices per scan, the CHO measurement could provide high repeatability with P<15% of 98.8%-99.9% at 12 mGy with IR reconstruction on all four scanners. On scanner A, P<15% were 91.5%-99.9% at the three dose levels and for all three object sizes while the numbers were 93.6%-99.998% on scanner B. P<15% were 96.5%-97.2% for the two deep learning reconstructions and 97.0%-99.97% for the four scan/reconstruction modes on the PCD-CT. The CHO provided highly repeatable measurements with over 95% probability that a CHO measurement would lie within the±15% tolerance for most of the dose levels and object sizes on the ACR phantom. The repeatability was maintained when the CHO was applied to images created with a commercial deep learning-based reconstruction and various scan/reconstruction modes on a PCD-CT. This study demonstrates that practical implementation of CHO for routine quality control and performance evaluation is feasible.

Setups for eliminating static charge of the ATLAS18 strip sensors

Construction of the new all-silicon Inner Tracker (ITk), developed by the ATLAS collaboration to beable to track charged particles produced at the High-Luminosity LHC, started in 2020 and is expected tocontinue till 2028. The ITk detector will include 18,000 highly segmented and radiation hard n+-in-psilicon strip sensors (ATLAS18), which are being manufactured by Hamamatsu Photonics. Mechanical and electrical characteristics of produced sensors are measured upon their delivery at several institutes participating in a complex Quality Control (QC) program. The QC tests performed on each individual sensor check the overall integrity and quality of the sensor.During the QC testing of ATLAS18 strip sensors, an increased number of sensors thatfailed the electrical tests was observed. In particular, IV measurements indicated an early breakdown,while large areas containing several tens or hundreds of neighbouring strips with low interstrip isolationwere identified by the Full strip tests, and leakage current instabilities were measured in a long-term leakage current stability setup. Moreover, a high surface electrostatic charge reaching a level of several hundreds of volts per inch was measured on a large number of sensors and on the plastic sheets, whichmechanically protect these sensors in their paper envelopes. Accumulated data indicates a clearcorrelation between observed electrical failures and the sensor charge-up.To mitigate the above-described issues, the QC testing sites significantly modified the sensor handlingprocedures and introduced sensor recovery techniques based on irradiation of the sensor surface with UVlight or application of intensive flows of ionized gas. In this presentation, we will describe the setupsimplemented by the QC testing sites to treat silicon strip sensors affected by static charge andevaluate the effectiveness of these setups in terms of improvement of the sensor performance.

Quality control of Bradyrhizobium inoculant strains: detection of nosZ and correlation of symbiotic efficiency with soybean leaf chlorophyll levels

Greenhouse gas emissions, such as N2O from excessive N-fertilizer use, are of concern. Symbiotic N2-fixation by pulses such as soybean might mitigate this issue, for which inoculants carrying locally adapted Bradyrhizobium strains are recommended. In the frame of this goal, enhancing the quality control of these inoculants is required on two key aspects: determining the presence of nosZ, for the strains being able to reduce N2O, and assessing N2-fixation potential. Previously it was demonstrated that, in soybean leaves, N-contents are well correlated with chlorophyll contents. However, no such correlations were made with either N obtained from N2-fixation or with nodules mass, which is an indicator of nodular activity. Here we aimed to leverage the correlation between N and chlorophyll levels to develop a simple and non-destructive laboratory method to be applied in quality control of inoculants, able to assess the N2-fixing capacity of rhizobial strains. To establish such correlations, we cultivated soybeans in vermiculite with N-free nutrient solution, and inoculated them with various Bradyrhizobium field isolates that displayed a range of symbiotic N2-fixing capacities. Subsequently, we measured chlorophyll with a portable chlorophyllometer, and correlated these measures with symbiotic parameters. Moreover, we tested for the presence of nosZ by PCR. We observed significant correlations between chlorophyll and shoot nitrogen obtained from N2-fixation and, in addition, we corroborated that chlorophyll contents were significantly correlated also with nodules mass. Two B. diazoefficiens strains stood out and possessed nosZ. In contrast, B. elkanii and B. japonicum isolates displayed lower chlorophyll and symbiotic performance, and lacked nosZ. Our findings highlight the potential of measuring chlorophyll contents and testing for the presence of nosZ as two straightforward techniques that may enhance laboratory tests for quality control, enabling selection of superior and safe locally isolated strains for soybean inoculants without increased production costs.

Assessment of In Situ Compactness and Air Void Content of New Asphalt Layers Using Ground-Penetrating Radar Measurements

This paper deals with the possibilities of ground-penetrating radar (GPR)-based quality control testing, which was demonstrated on an experimental road section of a ~220–240 m long Hungarian residential street. The measurements and their assessment aimed to control the prescribed compactness and air void content of newly built asphalt layers. Research has discussed the relationship between the air void content and the dielectric constant of asphalt layers, and provided empirical results for this relationship. We suggest a new logistic model with lower and upper asymptotes instead of the exponential formula often used in the literature. Contrary to this newly developed robust model, existing models are sensitive to extreme dielectric constant values due to the mathematical nature of their exponential function. The results of the new logistic model are compared to those of the Hoegh–Dai (HD) and Minnesota Department of Transportation (MnDOT) models on the basis of a few calibration data points. Through systematic data collection and analysis, the developed robust empirical model demonstrates a significant correlation between the relative permittivity and air void content in asphalt mixes, enabling accurate estimation of the air void content within a ±0.5% margin of error. The air void content can be applied to estimate the asphalt layer modulus. The developed model can be further exploited by utilizing a combination of GPR and drone technology. The “symbiosis” of these technologies can lead to a totally non-destructive imaging system, which can then be applied to environmental monitoring of roads and their surroundings in terms of quality control of asphalt compaction work and the hot asphalt mix behind the compaction roller during pavement construction.

Disintegration testing for orally disintegrating tablets (ODTs): An overview

Prescribing orally disintegrating tablet (ODT) dosage form is a common practice. For several populations, including geriatrics and pediatrics, ODTs are one of the most desired dosage forms. They are solid dosage forms designed to disintegrate or dissolve very quickly in contact with saliva as soon as they are placed in oral cavity of a patient. According to United States Pharmacopeia (USP), every dosage form has to pass some quality control tests to ensure uniformity and performance of this dosage form. For ODTs, disintegration test is fundamental to ascertain time required for tablets to break down and release their contents for dissolution and absorption. Additionally, it is a crucial predictive test for determining in vitro/in vivo association. There are no mandatory universal disintegration testing standards for ODTs, however, as stated in the USP. Instead, recent USP refers to individual manufacturer monograph specifications which may vary from one monograph to another. This article discusses several developed disintegration tests and methods for ODTs such as OD-mate testing, basket rack assembly, CCD camera, texture analyzer (TA), special disintegration equipment, prototype disintegration tester (PDT), simple approach, and modified wetting test and elaborates on their advantages and disadvantages.

Development and Evaluation of "The Delta Plus-Minus Even Distribution Check": A Novel Patient-Based Real-Time Quality Control Method for Laboratory Tests.

Laboratory testing of large sample numbers necessitates high-volume rapid processing, and these test results require immediate validation and a high level of quality assurance. Therefore, real-time quality control including delta checking is an important issue. Delta checking is a process of identifying errors in individual patient results by reviewing differences from previous results of the same patient (Δ value). Under stable analytical conditions, Δ values are equally positively and negatively distributed. The previous 20 Δ values from 3 tests (cholesterol, albumin, and urea nitrogen) were analyzed by calculating the R-value: "the positive Δ value ratio minus 0.5." This method of monitoring optimized R-values is referred to as the even-check method (ECM) and was compared with quality control (QC) testing in terms of error detection. Bias was observed on 4 of the 120 days for the 3 analytes measured. When QC detected errors, the ECM captured the same systematic errors and more rapidly. In contrast, the ECM did not generate an alarm for the one random error that occurred in QC. While QC did not detect any errors, the percentage of R-values exceeding the acceptable range was under 2%, the number of days generating alarms was between 16 and 21 days, with short alarm periods, and a median number of samples per alarm period between 7 and 9 samples. The ECM is a practical real-time QC method, controlled by setting R-value conditions, that quickly detects bias values.

Ensuring the quality of 3D printed medicines: Integrating a balance into a pharmaceutical printer for in-line uniformity of mass testing

Semi-solid extrusion (SSE) 3D printing has great potential to be integrated in a clinical setting, with the use of pre-filled and disposable pharma-ink syringes meeting regulatory good manufacturing practice (GMP) requirements. Uniformity of mass testing is a critical quality attribute and is carried out by weighing a specific amount of dosage units in a single batch and finding the average mass to evaluate any deviations. However, this test for small batches of 3D printed medicines may require weighing the entire manufactured batch. To overcome this limitation, an in-line analytical balance was implemented inside a GMP pharmaceutical 3D printer, with a specialised software-controlled weighing system for the automated mass uniformity testing of the entire printed batch. Three different dose batches (n = 28) of hydrocortisone pharma-ink were 3D printed and subjected to in-line mass uniformity testing. The developed software was capable of registering the weights of all individual printlets and accurately detecting any deviations within the accepted limits. Only one printlet was outside the accepted weight range, a result of the first print often being imperfect due to the semi-solid nature of the pharma-ink. The weight results were compared against an external analytical balance, and no significant differences were found. This study is the first to integrate an analytical balance inside a pharmaceutical printer, automating the dosage form mass uniformity testing which can save time, labour, and resources, whilst improving the quality control testing of 3D printed pharmaceuticals.

Impact of Electronic Collimation on Reducing Unnecessary Patient Dose in Digital Radiography.

In radiology, optimizing radiation protection is crucial, and field collimation plays a critical role in minimizing patient dose. As technology has evolved, electronic collimation has become the preferred method due to its effectiveness in digital imaging systems, replacing traditional film-screen systems. The current study aimed to investigate the prevalence of cropping in digital radiography and its potential impact on patient radiation dose because of improper collimation practices. This retrospective analysis was conducted on digital X-ray machine images. Quality control tests were performed to ensure equipment accuracy, and image cropping was then measured by analyzing archived images. Finally, the cropped image fraction and associated unnecessary radiation doses were calculated. Quality control tests confirmed that all imaging equipment was functioned within acceptable alignment and angle tolerances. The analysis of 911 images revealed a high prevalence of cropping (82%), with significant variation across different projections. Lateral knee images exhibited the highest cropping rate (96.2%), while abdominal images had the lowest (36.1%). Electronic image cropping can lead radiologic technologists to inaccurately define the primary radiation field, affecting image quality and potentially increasing patient radiation exposure. Based on the obtained results, proper collimation can reduce the average Dose Area Product (DAP) by 29.01%. This approach not only enhances patient safety but also minimizes unnecessary radiation exposure and potentially reduces healthcare costs.

Stability-indicating HPLC method optimization using quality by design with design of experiments approach for quantitative estimation of organic related impurities of Doripenem in pharmaceutical formulations

Doripenem (DM), an antibiotic used for kidney, lung, and urinary infections, underwent the development of a robust high-performance liquid chromatography (HPLC) technique using the quality-by-design approach. This method, integrating design-of-experiments, detected organic impurities in both drug substances and formulated products. Operating with a C18 analytical column in a binary gradient mode with potassium phosphate buffer (pH 6.1) and acetonitrile as mobile phases, the method ran at a flow rate of 1.20 ml/minutes, with an injection volume of 20-μl and a column temperature of 45°C. Stability testing under various conditions, including hydrolysis, oxidation, heat, humidity, and light exposure, confirmed the method’s reliability without interference. Validation studies, compliant with ICH guidelines, revealed quantitation limits of 0.006%, linearity between 0.060 and 1.800 μg/ml (R2 &gt; 0.999), and recoveries ranging from 96.8% to 99.1%. This HPLC method was effectively used for stability assessment in quality control testing, assessing doripenemic acid, doripenem assay, and organic impurities.

Formulation and Validation of An Analytical Method for the Estimation of Rabeprazole Sodium Delayed-Release Tablets

Background Rabeprazole sodium is a proton pump inhibitor used for the treatment of peptic ulcer and gastroesophageal reflux disease by inhibiting the enzyme HKATPase the acidic pump. In addition erosive esophagitis and Zollinger-Ellison syndrome are treated with it.In this study the objective was to develop a pharmaceutically stable and cost-effective and quality-improved formulation and UV spectrophotometry method have been developed to estimate Rabeprazole sodium delayed-release tablets. To achieve these goals various prototype formulation trails will be taken and evaluated.Methods Rabeprazole sodium prolonged release tablets were prepared by direct compression technique used to the different excipients as well as varying concentrations of polymer proportion using HPMC phthalate 55 which is an enteric coating material.Results The results indicated that the final product formulation 12 met all the specifications of the physical properties and invitation release and is comparable to the innovator product.Conclusions In the present study Rabeprazole enteric-coated tablets were prepared using HPMC phthalate 55 enteric polymer. Formulation 12 was found to be the best of all formulations showing drug release that matches the innovator product so all quality control tests were performed for conformation for the formulation. The tablets were tested for acid release during the stability period and the results confirmed that the results were within the limits.

Evaluacija funkcije unutrašnje kontrole kvaliteta automatskog biohemijskog analizatora Kehua Polaris c2000

Background: The present study aims to (1) evaluate the autoanalyser quality control (QC) module of the Kehua Polaris c2000 automatic modularised biochemical analyser and (2) verify the impact of the analyser's automatic implementation of internal QC (IQC) testing at a set time point on the results of IQC and turnaround time (TAT). Methods: For 5 consecutive days, three different methods were used to conduct IQC. Method 1: Internal QC was carried out at 8:00 every day. Method 2: The QC products were placed in the instrument calibration QC plate in the afternoon, and the instrument was set to measure the products at 7:00 the next day automatically. Method 3: The QC products were placed in the instrument calibration QC plate, and the instrument was set up for automatic measurement at 7:30 every day. All three methods were compared and evaluated. The effect of IQC on the TAT was monitored using method 2. Results: There were no statistical differences in the IQC results between methods 2 and 1. However, there were statistical differences in some items between methods 3 and 1; thus, the IQC results of method 2 can be adopted. Implementing method 2 for IQC can help achieve a significant TAT-saving of 35.23 min during the automatic retest process after the IQC indicates an out-of-control situation. This time reduction is highly valuable for improving efficiency and streamlining the testing workflow. Conclusions: Using the autoanalyser QC module of the Kehua Polaris c2000 automatic modular biochemical analysis system to perform IQC has no impact on the IQC test results and can save TAT, as well as automatically correct most out-of-control occurrences.