https://lnkd.in/gHcc-DiV Article Title: Validated method for estimation of ethamsylate by UV-spectroscopy Author(s): Sanjay Kumar Karan* and Subhasmita Subhadarshinee Journal: International Journal of Pharmaceutical Sciences and Developmental Research Journal ISSN: 2640-7760 Abstract: For the estimation of ethamsylate in pharmaceutical tablet dosage forms an accurate, simple, efficient spectrophotometric method was developed and validated. It showed absorption maxima at 300 nm with distilled water. According to ICH guidelines, the method was validated concerning specificity, linearity, accuracy, and precision. Ethamsylate’s linearity and range were found to be 5 to 50 μg/ml, with a correlation coefficient of 0.999. The analysis's findings were verified statistically and estimation of ethamsylate was done in marketed formulation. #Ethamsylate #UVvisiblespectrophotometer #Validationmethods #MedicinalChemistry #DrugDevelopment #Pharmacokinetics #Pharmacodynamics #Pharmacogenomics #Toxicology #Pharmaceutics #Biopharmaceutics #Pharmacognosy #PharmaceuticalChemistry #PharmacyPractice #CommunityPharmacy #HospitalPharmacy #IndustrialPharmacy #RegulatoryAffairs #DrugFormulation#DrugDelivery #PharmacyManagement #PharmaceuticalTechnology #PharmacyEducation #ClinicalTrials
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https://lnkd.in/gbkjiSaq Article Title: Glass Delamination in sterile formulations and Drug Recalls: A Review Author(s): Kabirdas B Ghorpade* and Sharda M Shinde Journal: International Journal of Pharmaceutical Sciences and Developmental Research Journal ISSN: 2640-7760 Abstract: Injectable formulations are constantly facing continuing challenges of glass compatibility. To assure glass compatibility of the injectable formulation in the area of current interest. Most of the common and serious challenges of glass compatibility are glass delamination. Glass delamination is basically the degradation of the glass and formation of the flakes as a result of the incompatibility with the product stored. The other factors which contribute to glass delamination are the Type of glass container used, Storage condition, and Pharmaceutical Processings like terminal sterilization. Glass delamination should be taken very seriously as it is when present in the formulations it is directly related to the health of the patient. This review describes the Factors responsible for the glass delamination and its effect on patient health and the quality control analysis techniques of the same. #Glassdelamination #Terminalsterilization #Hydrolyticresistance #SEM #TEM #Drugrecalls #MedicinalChemistry #DrugDevelopment #Pharmacokinetics #Pharmacodynamics #Pharmacogenomics #Toxicology #Pharmaceutics #Biopharmaceutics #Pharmacognosy #PharmaceuticalChemistry #PharmacyPractice #CommunityPharmacy #HospitalPharmacy #IndustrialPharmacy #RegulatoryAffairs #DrugFormulation#DrugDelivery #PharmacyManagement #PharmaceuticalTechnology #PharmacyEducation #ClinicalTrials
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#Genotoxic impurities are compounds that can cause damage to DNA, potentially leading to cancer and other health risks. As a #pharmaceutical company or #CDMO, it is crucial to identify and quantify these #impurities to ensure that APIs, #excipients and formulations are safe and comply with #regulatory requirements. Join our Fireside Chat on April 24 to learn more on genotoxic impurities and how they affect the safety of medicines. In this interactive discussion Evonik's experts Michael Nonnenmacher, Daniel B., Jürgen Volz and Elizabeth White draw on their experience in #toxicology, #analytics, regulatory affairs and business development to address the latest trends and challenges in genotoxic impurity testing. The session is highly relevant to anyone working in #API clinical stage development, research, process development or #outsourcing at pharmaceutical and generic drug makers. Learn about the interdisciplinary approach needed to navigate the complex landscape of genotoxic impurities and make medicines safer for patients. To learn more and save your seat for the event please visit https://lnkd.in/eU2XbrHe. #webinar #gti #nitrosamines #m7 #hpapi #drugsubstance #cmo #contractmanufacturing #biopharma #pharma #healthcare #webcast
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Want to learn more about Genotoxic Impurities? Come join our Evonik experts for a fireside chat with on this important topic. hashtag #genotoxic #gti #Evonik #API #webinar
#Genotoxic impurities are compounds that can cause damage to DNA, potentially leading to cancer and other health risks. As a #pharmaceutical company or #CDMO, it is crucial to identify and quantify these #impurities to ensure that APIs, #excipients and formulations are safe and comply with #regulatory requirements. Join our Fireside Chat on April 24 to learn more on genotoxic impurities and how they affect the safety of medicines. In this interactive discussion Evonik's experts Michael Nonnenmacher, Daniel B., Jürgen Volz and Elizabeth White draw on their experience in #toxicology, #analytics, regulatory affairs and business development to address the latest trends and challenges in genotoxic impurity testing. The session is highly relevant to anyone working in #API clinical stage development, research, process development or #outsourcing at pharmaceutical and generic drug makers. Learn about the interdisciplinary approach needed to navigate the complex landscape of genotoxic impurities and make medicines safer for patients. To learn more and save your seat for the event please visit https://lnkd.in/eU2XbrHe. #webinar #gti #nitrosamines #m7 #hpapi #drugsubstance #cmo #contractmanufacturing #biopharma #pharma #healthcare #webcast
Critical impurities and limits: A fireside chat on genotoxic impurities (April 24, 2024, 10:00 a.m. EDT / 4:00 p.m. CEST)
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What does it take to safely navigate the complex landscape of #genotoxic #impurities and how can interdisciplinary teams deal with the discovery of unexpected impurities such as #nitrosamines? That's what our experts Michael Nonnenmacher, Daniel B., Jürgen Volz and Elizabeth White will discuss in our next Fireside Chat on April 24. Have you registered yet? Genotoxic impurities are compounds that can cause damage to DNA, potentially leading to cancer and other health risks. As a #pharmaceutical company or #CDMO, it is crucial to identify and quantify these impurities to ensure that APIs, #excipients and formulations are safe and comply with #regulatory requirements. In this discussion, our industry experts draw on their experience in #toxicology, #analytics, regulatory affairs and business development to address the latest trends and challenges in genotoxic impurity testing. Curious? To learn more and save your seat for the event please visit https://lnkd.in/eU2XbrHe. #webinar #gti #m7 #api #hpapi #drugsubstance #cmo #contractmanufacturing #biopharma #pharma #healthcare #webcast Evonik
Critical impurities and limits: A fireside chat on genotoxic impurities (April 24, 2024, 10:00 a.m. EDT / 4:00 p.m. CEST)
go.evonik.com
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🔍Come find us! 🦠Today marks day 1 of PDA - Parenteral Drug Association's Pharmaceutical Microbiology Conference 2024. Novatek International's SME's Corinne Cleary and Susan Cleary will be there to contribute to the innovative science behind bridging compliance and scientific advancement. 💡Feel free to chat with them about regulatory compliance in the industry and how it relates to new technologies. #innovatoin #technology #pharma #compliance #regulatorycompliance #microbiology
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🚀 Breaking Boundaries: Sustainable Practices with ACQUITY QDa II Mass Detector for Drug Impurity Testing! 🌈Purity and Safety of pharmaceutical products is essential for patient health, the ACQUITY QDa II Mass Detector offers a simple, robust, and easy-to-use solution. 🧪Gain valuable insights into drug substance development and manufacturing processes to save time and money! 💚 Discover how this sustainable mass detector complements traditional LC-UV workflows: [Link to article] #DrugSafety #MassDetection #ImpurityTesting #ACQUITYQDa #QualityControl #ThePowerOfMore
Breaking Boundaries: Sustainable Practices with Mass Detection Technology for Drug Impurity Analysis
labcompare.com
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Ensuring the safety and efficacy of pharmaceutical products involves more than just the active ingredients. The materials used in packaging and delivery systems can also impact patient safety. 🔎 This blog post explores the process of toxicological assessment of Extractables and Leachables (E&L), highlighting the importance of evaluating these substances to maintain product integrity. Happy reading! 👇 https://lnkd.in/eifBq66G #Pharma #QualityAssurance #Toxicology
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We're thrilled to announce our speakers for the 4th Annual Genotoxic Impurities Summit: Nitrosamines & Beyond! Join us as we bring together top experts in the field to dive deep into the latest advances, challenges, and regulatory updates around genotoxic impurities. 👥 This year’s speaker board includes industry pioneers, regulatory experts, and innovative thought leaders who are ready to share their invaluable insights. Don’t miss the opportunity to connect, learn, and drive meaningful change in how we approach genotoxic impurities. 📅 Mark your calendar, reserve your spot, and stay tuned for more updates on the event details! → Web Site: https://lnkd.in/duPU4HiE → Agenda: https://lnkd.in/dFkKUTvm #Genotoxic #Nitrosamines #Pharma #Regulatory #Pharmaceutical #Innovation #NDSRI #Mutagenic #Impurities #Drug #Quality #Safety #Risk #Beyond #Analytical #Science #Toxicology #Chemical
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Working with these gents has been a highlight of 2024 for me. They're amazing at what they do, and truly work hard to help advance Pharmaceutical Microbiology. They have an instrument called APAS Independence, which is an automated plate assessment system that uses artificial intelligence to screen, interpret, and sort Environmental Monitoring plates without needing human (microbiologist) intervention. If you are here at PDA - Parenteral Drug Association Microbiology, go check out their booth to learn more. There are also two posters, one with Phil from AstraZeneca and the other discusses their primary validation data. Download them both from the PDA app. If you are not here in person, check out the article we published about their powerful data in this month's edition of American Pharmaceutical Review. I will link it in the comments below. The solution is here, no more reading (or misreading) hundreds of plates a day. Whew.
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