We’re excited to share our latest application note: Rapid and Quantitative Screening of Nitrosamines in Drug Products Using Headspace-SIFT-MS. This study highlights how the Syft Tracer Pharm11 solution delivers: ✅ Compliance with USP criteria for six nitrosamines. ✅ Exceptional sensitivity with low limits of quantitation (as low as 0.03 ppm for NDEA). ✅ High recovery rates in even the most complex drug matrices. ✅ Significant savings on solvents, consumables, and operational complexity compared to traditional chromatographic methods. With headspace-SIFT-MS, screening for nitrosamines and volatile impurities has never been faster, simpler, or more efficient. Check out the full application note to learn how you can streamline your workflows and achieve more sustainable operations at https://hubs.ly/Q033CRmT0 #PharmaInnovation #Nitrosamines #SIFTMS #DrugSafety #ApplicationNote
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Download this application note, ICP-MS Analysis of Elemental Impurities in Oral Drug Products, to see how the ICPMS-2050 easily meets the acceptance criteria for accuracy, precision, and quantitative limits described in the JP, EP, and USP. In addition, a pre-set method simplifies the analytical procedure and enables a more efficient workflow. Check it out. https://lnkd.in/eAEeTrpA #icpms #elementalimpurities #usp #analyticalinstruments #shimadzu
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Once you have your candidate API, how can you ensure you’re producing this molecular structure as efficiently as possible, whether you’re making 5g or 5kg? 🤔 On June 12 at 16:30 CET, join us for the first webinar in this series – a roundtable discussion about navigating challenges in API Solid-State Analysis 🗣️ Join our industry experts Natalia Dadivanyan, Anne Virden, Kuo-Chih Shih and Lieven Kempenaers, Ph.D. as they examine the most common challenges to API scale-up. They’ll explore how applying the right analytical technologies at the right time can help you control: ✅ Particle size and shape ✅ Crystallization & polymorphism ✅ Chemical purity They’ll also share insights into the latest innovations from Malvern Panalytical and how they can help you get on top of these challenges, making sure you can achieve reproducible results every time. Register for free 👉 https://bit.ly/3RgcTXb #MalvernPanalytical #Pharma #API #Webinar
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Are you struggling with non-conformance issues when using handheld Raman to ID test raw materials like ethanol and polysorbates in amber bottles? It's not you and it's not Raman! Discover the limitations of conventional backscattering Raman solutions and learn how SORS can help you eliminate your non-conformance problems. Read our application notes on the Agilent Vaya Handheld Raman—No sampling, no container opening for ID testing through transparent and opaque containers. https://bit.ly/4cjw8It #Raman #spectroscopy #handheldraman #pharma #biopharma
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Are you struggling with non-conformance issues when using handheld Raman to ID test raw materials like ethanol and polysorbates in amber bottles? It's not you and it's not Raman! Discover the limitations of conventional backscattering Raman solutions and learn how SORS can help you eliminate your non-conformance problems. Read our application notes on the Agilent Vaya Handheld Raman—No sampling, no container opening for ID testing through transparent and opaque containers. https://bit.ly/4cjw8It #Raman #spectroscopy #handheldraman #pharma #biopharma
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Thomas Kelleher, Ph.D. (Supplier of GMP Yoil®️), Ph.D., CEO of Xylome , and Thomas Jeffries, Ph.D., President, bring 40 years of expertise to revolutionize drug delivery. Their innovation, like TopicOil™, uses non-conventional yeasts to transform hydrophobic drug delivery systems. Read More: https://cutt.ly/UeVSOWl9 #XylomeCorporation #DrugDeliveryInnovation #HealthcareInnovation #HydrophobicDrugDelivery #DrugDeliverySolutions #Pharmanlifescience
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How can you use cyclodextrins in controlled release systems? While this is not really the "nature" of cyclodextrins, proper application and unique compounds can lead to fancy release profiles. There are several approaches where CDs can be used, such as: - Prolonged Release Profiles - Inclusion Complexes for Controlled Release - pH-Responsive Drug Release - Temperature-Triggered Release - Enzyme-Responsive Delivery Systems Learn more: https://lnkd.in/dTVE4CMz #drugdelivery #precisionmedicine #cyclodextrin
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A recent publication by Merck demonstrates the effectiveness of benchtop quantitative NMR (qNMR) as a reliable and user-friendly method for quantifying nonionic surfactant excipients (NISEs) in biologics formulations. Traditionally, NMR has been a complex characterization technique, challenging to transfer to a QC lab. However, benchtop instruments are changing the game, paving the way for routine use of NMR in specific applications. 🎯 𝐊𝐞𝐲 𝐭𝐚𝐤𝐞-𝐚𝐰𝐚𝐲𝐬: • 🧪 Benchtop qNMR can accurately quantify polysorbates 20 and 80 (PS20, PS80) and poloxamer 188 (P188) in biologics formulations. • 🌿 This method is non-destructive and generates no solvent waste, making it a greener alternative to traditional liquid chromatography (LC) methods. • 🔍 The technique proves effective under biopharmaceutically relevant conditions, even at low concentrations (≤0.025% w/v). • 🏭 It offers potential for routine integration within analytical and QC laboratories across the pharmaceutical development and manufacturing sectors. For a deeper dive into this work, check out the full publication here: 🔗 https://lnkd.in/eHyFQfKE #biopharmaceuticals #NMR #analyticalchemistry #drugdevelopment #pharma #sustainability Ciarán C. Lynch, Ph.D., Gennady Khirich and Ryan T. Lee
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QuantCaps™: Injectable-ready, matrix-matched reference materials for drug analysis on GC and LC platforms. Customizable to your lab's specific matrix, analytes, method, and platform, QuantCaps™ streamlines calibrations, validations, and method development for routine drug testing in complex matrices. Learn more here: https://hubs.ly/Q02DpTZX0 #QuantCaps #DrugAnalysis #GCLiquidChromatography #LabStandardization
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How can a binding document like Pharmacopeia contain incorrect data? Namely, The following mathematical relationships is applied: F0 = D121(log10N0 - log10N) for the calculation of F0. The Fo value or "F-value" is physical, not biological, value which represents the equivalent time at a reference temperature (usually 121.1°C) required to achieve a certain level of microbial lethality. By using Fo values, the sterilization process can be standardized across different environments and conditions. This ensures consistency in the effectiveness of sterilization regardless of variations in actual time and temperature experienced during the process. But, according to EuPh 10.3, Fo is always different depending on which BI you use, which is the exact opposite of its purpose, which is to standardize sterilization efficiency depending on different conditions. #sterilization #autoclave #lethality #gmp #pharmacopeia #sterile #aseptic #pharma #sterilisation
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The cost of getting a drug to market has increased 1000 % since the 1980s, so this webinar is a timely opportunity to understand how we can optimise API development efficiency.
Once you have your candidate API, how can you ensure you’re producing this molecular structure as efficiently as possible, whether you’re making 5g or 5kg? 🤔 On June 12 at 16:30 CET, join us for the first webinar in this series – a roundtable discussion about navigating challenges in API Solid-State Analysis 🗣️ Join our industry experts Natalia Dadivanyan, Anne Virden, Kuo-Chih Shih and Lieven Kempenaers, Ph.D. as they examine the most common challenges to API scale-up. They’ll explore how applying the right analytical technologies at the right time can help you control: ✅ Particle size and shape ✅ Crystallization & polymorphism ✅ Chemical purity They’ll also share insights into the latest innovations from Malvern Panalytical and how they can help you get on top of these challenges, making sure you can achieve reproducible results every time. Register for free 👉 https://bit.ly/3RgcTXb #MalvernPanalytical #Pharma #API #Webinar
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