Accreditation and Quality Assurance最新文献

{"title":"Evaluating the impact of reagent lot changes and environmental factors on quality control consistency in a measles IgM enzyme-linked immunosorbent assay","authors":"Nagaraj Perumal,&nbsp;Jaya Lalwani,&nbsp;Rajeev Kumar Jain,&nbsp;Deepti Chaurasia","doi":"10.1007/s00769-025-01658-6","DOIUrl":"10.1007/s00769-025-01658-6","url":null,"abstract":"<div><p>Accurate serological testing relies on robust quality control (QC) procedures and the identification of factors influencing assay reliability. This retrospective study evaluated the impact of ambient laboratory conditions and reagent lot variability on the performance of the Euroimmun Anti-Measles Virus NP IgM ELISA, using data from 215 valid assay runs conducted between January 2023 and December 2024. QC metrics—Positive Control, Negative Control (NC), and Internal Quality Control (IQC) ratios—were analyzed across nine reagent kit lots. The IQC material, prepared and validated by the national serology reference laboratory, was used consistently to monitor longitudinal performance. Ambient temperature (20.0–25.0 °C) and humidity (21–84%) showed no significant linear correlation with QC ratios (<i>p</i> &gt; 0.05). However, statistically significant variation in QC values was observed across reagent lots, especially for NC and IQC. NC failures (~ 7.7%) were dispersed and not linked to environmental extremes, suggesting possible procedural variation. In select instances, the IQC flagged deviations not captured by kit-supplied controls, underscoring its added value. These findings highlight reagent lot variability as the primary contributor to QC variation and reinforce the need for lot-specific validation, consistent monitoring, and integration of independent IQC materials as part of a robust quality assurance framework in accredited serological laboratories.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"30 5","pages":"581 - 589"},"PeriodicalIF":1.0,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145073688","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Green chemistry-driven RP-HPLC method for diltiazem and lidocaine hydrochloride in bulk and gel formulations using AQbD","authors":"Shivam Kumar,&nbsp;Neha Singh,&nbsp;Sourabh Satapathy,&nbsp;Kuladip Barman,&nbsp;Balak Das Kurmi,&nbsp;Preeti Patel","doi":"10.1007/s00769-025-01661-x","DOIUrl":"10.1007/s00769-025-01661-x","url":null,"abstract":"<div><p>In this work, a simple, specific, accurate, and precise Reverse-Phase High-Performance Liquid Chromatography (RP-HPLC) method for estimating lidocaine hydrochloride and diltiazem hydrochloride in bulk and pharmaceutical dosage forms is developed and validated. The method uses an isocratic RP-HPLC approach for the separation and quantification of these compounds. Chromatographic analysis was performed on a Waters HPLC system that was fitted with a Thermo Scientific C₁₈ ODS column (250 mm × 4.6 mm, 5 μm). The mobile phase was supplied at a flow rate of 1.0 mL/min and consisted of methanol, acetonitrile, and buffer (orthophosphoric acid) in a 70:20:10 ratio. At 233 nm, a sharp, symmetrical peak with retention periods of 2.5 and 4.4 min was obtained through detection. Many parameters, such as linearity, accuracy, precision, specificity, and robustness, were evaluated for the method's validation. The method showed linearity throughout a concentration range of 20–100 µg/mL with correlation coefficients (<i>r</i>²) of 0.999 and 0.998, respectively, and the recovery of diltiazem hydrochloride varied from 99 to 100 %. Method optimization was accomplished through the use of a Box–Behnken design with desirability functions, and the validation parameters satisfied the requirements specified in the ICH Q2 (R1) recommendations. The AGREE assessment of the proposed RP-HPLC technique resulted in a score of 0.68, indicating a good balance between analytical performance and environmental sustainability. This confirms its environmental sustainability and suitability as an eco-friendly analytical method.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"30 5","pages":"605 - 623"},"PeriodicalIF":1.0,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145073689","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of RP-HPLC method for determination of amlodipine besylate, metoprolol succinate and telmisartan by integration of box–behnken design and greenness–blueness assessment tools","authors":"Macwan Prachi,&nbsp;Prajapati Anand,&nbsp;Patel Prasha,&nbsp;Tandel Devang,&nbsp;Patel Kalpana","doi":"10.1007/s00769-025-01660-y","DOIUrl":"10.1007/s00769-025-01660-y","url":null,"abstract":"<div><p>In this research work, a robust, Box–Behnken design-assisted reversed-phase liquid chromatography (RPLC) has been optimized for the quantification of Amlodipine Besylate, Metoprolol Succinate and Telmisartan followed by validation of method. Method is developed by utilizing Shimadzu LC-2010C HT HPLC system, autosampler injector and photodiode array detector. The separation was attained utilizing C₁₈ (5 μm, 250 × 4.6 mm), Phenomenex column as stationary phase. Optimized mobile phase was methanol/50 mM ammonium phosphate buffer adjusted to pH 3.5 (65:35%v/v). Detection wavelength set for estimation was 230 nm, and flow rate of mobile phase optimized was 1 ml/min. Box–Behnken design as a part of Analytical Quality by Design approach was used for optimization considering the critically influencing method attributes, flow rate (ml/min), molar concentration of buffer (mM) and buffer solution volume (ml) that resulted in optimized chromatographic conditions. The linearity exhibited a linear response within a range of 2–10 µg/mL, 19–95 µg/mL and 16–80 µg/mL (correlation coefficient: 0.9988, 0.9983 and 0.9972) for Amlodipine Besylate, Metoprolol Succinate and Telmisartan, respectively. The analytical method exhibited appropriate precision and accuracy considering the RSD values as less than 2% and mean recoveries in the range of 99.99–101.00% for all three drugs. Validation was ensured in compliance with ICH Q2 (R1) in terms of method’s sensitivity, accuracy, robustness and appropriate linearity for Amlodipine Besylate, Metoprolol Succinate and Telmisartan. Environmental impact evaluation of the developed method was conducted through the utilization of various software such as complex GAPI, AGREE and BAGI confirming that the optimized method was ecologic and environmentally safe. The method has been efficient in every parameter with accurate sustainability, simplicity, sensitivity and reproducibility.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"30 5","pages":"563 - 579"},"PeriodicalIF":1.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145073639","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"UV spectrophotometry and HPLC quantification of vibegron: evaluating whiteness, greenness, and blueness","authors":"Nidhi Vadnere,&nbsp;Mital Patel","doi":"10.1007/s00769-025-01655-9","DOIUrl":"10.1007/s00769-025-01655-9","url":null,"abstract":"<div><p>Vibegron is a beta-3 adrenergic agonist receptor used in the treatment of overactive bladder. Present study aims to develop and validate enviornmentally sustainable UV spectrophotometric and Chromatography methods for the quantitative analysis of the Vibegron in both bulk drug substances and products, addressing the current lack of established quantification methods. The UV spectrophotometric method was developed using Acetonitrile as the solvent at a wavelength of 248 nm. While the HPLC method contained, Kromasil Classic C18 (250 mm*4.6 mm*5 µm) column, detection wavelength 248 nm, mobile phase composition Acetonitrile and Ammonium Acetate buffer 4.5 pH 44:56 (v/v) atflow rate of 0.8 mL/min, and injection volume 10 µL. The ICH Q2 (<i>R2</i>) guideline is followed to validate developed methods, including parameters like specificity, linearity, range, accuracy, assay, precision, LOD, LOQ, and robustness. The UV spectrophotometric and HPLC methods demonstrated strong linearity with <i>R</i>² = 0.9993 and 0.9972, respectively. The percentage recovery for accuracy and assay at each level was between 98 and 101% for both methods. Results were found to be consistent with an RSD &lt; 2 for both methods for precision and robustness parameters. LOD was found to be 0.6520 µg/mL and 0.5767 µg/mL, and the LOQ was found to be 1.9759 µg/mL and 1.7476 µg/mL, respectively, for the UV and HPLC method. Sustainability assessment using standard tools revealed that the UV spectrophotometric method is greener and more economical, whereas, HPLC offers higher precision with increased cost and environmental impact. The methods ensure quality control, regulatory compliance, and sustainable, cost-effective analysis.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"30 4","pages":"407 - 417"},"PeriodicalIF":1.0,"publicationDate":"2025-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145170334","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Strengthening Food Safety in Iraq through proficiency testing: enhancing laboratory competence and quality assurance: a review","authors":"Rebaz M. Mustafa,&nbsp;Bnar Jawdat Ahmed,&nbsp;Abdulrahman Ismael,&nbsp;Rebaz Qader,&nbsp;Salam G. Taher,&nbsp;Rayan A. Hussein","doi":"10.1007/s00769-025-01656-8","DOIUrl":"10.1007/s00769-025-01656-8","url":null,"abstract":"<div><p>Ensuring food safety remains a pressing public health and economic imperative in Iraq, a nation marked by rich agricultural traditions yet hindered by infrastructural challenges and inconsistent regulatory enforcement. Despite established legal frameworks, significant gaps in compliance have led to persistent contamination issues, including heavy metals in meats, pathogenic bacteria in dairy products, and adulteration across food commodities. Proficiency testing (PT) can serve as a catalyst to improve this situation by providing an external quality assurance mechanism that benchmarks laboratory performance and fosters accuracy and consistency. International standards underscore the importance of PT-ISO/IEC 17025:2017 and ISO/IEC 15189:2022 requires laboratories to regularly verify result accuracy via inter-laboratory comparisons, and ILAC’s 2024 policy (P9:01/2024) mandates that accreditation bodies utilize PT outcomes as part of the lab accreditation process. Implementing robust PT schemes in Iraq, however, faces barriers—from technical limitations (scarcity of trained personnel and accredited PT providers) and financial constraints to limited regulatory enforcement compelling labs to participate. This review critically examines these challenges and synthesizes strategies to integrate PT into Iraq’s food safety framework. Key recommendations include investing in laboratory capacity (modernizing equipment and training staff), establishing a national PT program (or partnerships with international PT providers) to cover priority contaminants, and strengthening governance by embedding PT participation into national food safety regulations and laboratory accreditation criteria. By institutionalizing proficiency testing, Iraq can enhance the reliability and comparability of laboratory results, improve the credibility of its food safety oversight, and align its practices with international standards of accreditation and quality assurance.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"30 4","pages":"445 - 455"},"PeriodicalIF":1.0,"publicationDate":"2025-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145168980","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating the measurement uncertainty in determination of sulfamethoxazole in compound sulfamethoxazole tablets by dual-wavelength spectrophotometry","authors":"Dalin Chann,&nbsp;Sophany Ret","doi":"10.1007/s00769-025-01653-x","DOIUrl":"10.1007/s00769-025-01653-x","url":null,"abstract":"<div><p>An evaluation of measurement uncertainty in the determination of sulfamethoxazole (SMZ) in compound sulfamethoxazole tablets using dual-wavelength spectrophotometry is presented. The average SMZ content determined was 0.3570 g/tablet, with an average tablet mass of 0.5671 g. The method leverages the ability to minimize interference from overlapping spectral bands by measuring absorbance differences at two distinct wavelengths (257 nm and 306 nm). Sources of uncertainty, including the average mass of tablets, sample mass, and absorbance values, were systematically analyzed. Findings reveal a combined standard uncertainty for a single determination of 0.0154 g/tablet. Absorbance measurement uncertainty, particularly for the standard at 306 nm (A_C306) and the sample at 306 nm (A_s306), were identified as significant contributors to the overall uncertainties. Triplicate analysis provided a limited reduction in the impact of repeatability uncertainty, with the overall combined standard uncertainty improving minimally to 0.0154 g/tablet. These results suggest that method optimization, such as adjusting concentrations to ensure absorbance readings are in a more optimal range, or consideration of alternative techniques may be needed to enhance the precision of SMZ quantification, contributing to robust quality control in pharmaceutical analysis.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"30 4","pages":"399 - 406"},"PeriodicalIF":1.0,"publicationDate":"2025-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145168981","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating the measurement uncertainty in determination of the content of benzylpenicillin sodium for injection by acid–base titration","authors":"Dalin Chann,&nbsp;Sophany Ret","doi":"10.1007/s00769-025-01648-8","DOIUrl":"10.1007/s00769-025-01648-8","url":null,"abstract":"<div><p>This evaluation focused on measurement uncertainty in determining the content of benzylpenicillin sodium in injections using acid–base titration. The process involved β-lactam ring hydrolysis and back-titration of excess alkali with hydrochloric acid (HCl). The study identified and quantified uncertainty sources including repeatability, weighing, volumetric measurements (burette), and titrant concentration. The combined standard uncertainty was calculated using a spreadsheet approach adhering to GUM principles, and the impact of room temperature variations and triple determinations was assessed. The average benzylpenicillin sodium content was determined to be 96.9% with an expanded uncertainty (<i>k</i> = 2) of ± 2.2%. Triple determination reduced the contribution from repeatability, but volumetric uncertainties and titrant concentration uncertainty remained substantial contributors. Correcting for a mean room temperature of 25 °C did not markedly alter the result. Incorporating all quantified uncertainty components provided a reliable estimate of benzylpenicillin sodium content with defined confidence intervals. However, the inherent limitation of titration's specificity and the need for full metrological traceability of titrants are important considerations.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"30 4","pages":"391 - 397"},"PeriodicalIF":1.0,"publicationDate":"2025-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145168982","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"On the measurement uncertainty caused by finite resolution and its relation to the rectangular distribution","authors":"Petr Křen","doi":"10.1007/s00769-025-01662-w","DOIUrl":"10.1007/s00769-025-01662-w","url":null,"abstract":"<div><p>The paper points out that the current practice of evaluation of measurement uncertainty for a finite resolution of measuring instruments uses the rectangular distribution to describe such an effect. The approximate formula for a calculation of the expanded uncertainty of the normal distribution convolved with the rectangular distribution as a contributing distribution is presented and compared with the direct effect of a finite resolution simulated on the normally distributed data. The interpretation of the numeric rounding caused by a finite resolution as a variable with the rectangular distribution is discussed and the solution for estimations with a quantized distribution that is observed is suggested. This approach allows to avoid underestimation in the evaluation of measurement uncertainties, especially for routinely calibrated instruments, where the finite resolution is often the dominant contribution to the uncertainty budget.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"30 4","pages":"383 - 389"},"PeriodicalIF":1.0,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145167250","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Highly sensitive validated RP-HPLC–DAD method for simultaneous quantification of doxorubicin and docetaxel: augmenting industrial application","authors":"Amrendra Tiwari,&nbsp;Pavan K. Yadav,&nbsp;Aarti Abhishek Shah,&nbsp;Keerti Mishra,&nbsp;Rafquat Rana,&nbsp;Pooja Yadav,&nbsp;Shourya Tripathi,&nbsp;Manish K. Chourasia","doi":"10.1007/s00769-025-01645-x","DOIUrl":"10.1007/s00769-025-01645-x","url":null,"abstract":"<div><p>Doxorubicin (DOX) and Docetaxel (DTX) are commonly being employed and investigated in combination therapy against cancer, however, there does not exist a validated method to simultaneously analyse these two drugs. To address this gap, a simple, rapid, and sensitive reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous estimation of DOX and DTX. The optimized separation was achieved using a C18 column employing an isocratic mobile phase comprising of acetonitrile and octane sulphonic acid buffer (25:75 v/v) with a flow rate of 1 mL/min. The detection was carried out at 230 and 240 nm with DTX and DOX at retention times of 3.4 min and 7.9 min, respectively, with a total analysis duration below 10 min ideal for formulation development and research purposes. The limit of detection (LOD) and limit of quantification (LOQ) was found to be 67.96 ng/mL and 277.86 ng/mL for DOX and 65.78 ng/mL and 268.84 ng/mL for DTX, respectively. The recoveries were within the range of 98–102% ascertaining the accuracy and precision of the method. The developed approach was used to evaluate forced degradation, matrix impact, and assay experiments in acid, base, oxidative, light and temperature-induced stress environment considering its applicability in formulation development. All the applicability studies conducted proved that the method is capable of estimating both drugs distinctively and specifically in these applications. It can be used to fulfil the unmet need for a validated analytical toolset required for industrial and research applications.</p><h3>Graphical Abstract</h3><div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"30 4","pages":"367 - 382"},"PeriodicalIF":1.0,"publicationDate":"2025-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145166735","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Fit-for-purpose (target) measurement uncertainty (answer to reviewer)","authors":"Fernando C. Raposo,&nbsp;Michael H. Ramsey","doi":"10.1007/s00769-025-01654-w","DOIUrl":"10.1007/s00769-025-01654-w","url":null,"abstract":"","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"30 4","pages":"487 - 488"},"PeriodicalIF":1.0,"publicationDate":"2025-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145165687","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}