Bry-Air (Asia) Private Limited’s Post

Check out our new application note that unveils a cutting-edge method for analyzing NTTP (a genotoxic nitrosamine impurity) in sitagliptin, in line with US FDA guidelines. 🔬✨ The short-term acceptable intake (AI) limit of NTTP in sitagliptin should not exceed 246.7ng/day, while the lifetime exposure AI limit is set at 37ng/day. This method for the determination of NTTP in sitagliptin utilizing Shimadzu LCMS-8045 triple quadrupole tandem mass spectrometry system exhibits high sensitivity with a quantitation limit of 5 ng/day, significantly surpassing the acceptable intake limit of 37 ng/day, making it perfect for routine testing of NTTP in both raw materials and formulations of sitagliptin. Download the application note to learn more about this innovative approach: https://lnkd.in/dbuDhb4g #Shimadzu #NTTP #nitrosamine #sitagliptin #pharmaceutical #massspectrometry #LCMS #LCMSMS #pharma

We’re thrilled to unveil our updated range of DC Granules ahead of CPHI Milan 2024! 🌍 As a leader in DC Granule manufacturing, we continue to push the boundaries with our unique, proprietary technologies. These granules are manufactured at our state-of-the-art facility, compliant with USFDA, EUGMP, UKMHRA, TGA, and WHO GMP standards, with a 500MT annual capacity. We’re ready to support your formulation needs with high-quality, reliable solutions. 🔗 Let’s Meet at CPHI Milan! We’d love to discuss how our products can help accelerate your business growth. Schedule a meeting with us at Stall #6SU2, or email us at info@ysklabs.com. #CPHI2024 #YSKLabs #PharmaInnovation #BusinessGrowth #MeetUsInMilan #PharmaPartnership #PharmaExhibition #USFDA #EUGMP #UKMHRA #TGA #WHOGMP #PharmaIndustry #LetsConnect #ysk #ysklabs #ysklaboratories #ysklaboratoriespvtltd #cphi #cphi2024 #cphimilan #cphiworldwide #attheheartofpharma #AtTheHeartOfPharma #india #smart #api #formulation #smartapi #formulationdevelopment #formulations #crams #cro #cmo #pharmaceutical #pharmaceuticalindustry #pharmaceuticalmanufacturing #manufacturing #formulation #formulationdevelopment #pharmaceutical #businessdevelopment #dc #dcgranules #directlycompressiblegranules #directlycompressible #smartapis #shamrock #shamrockmedicaments #shamrockmedicamentsindialtd #global #globalfootprint #globalpresence #globalscale

#GlobalBiosimilarWeek Chennupati Indo-American School of Pharmacy #Biosimilars provide a significant opportunity to expand patient access to essential medicines without sacrificing product quality. Data shows that when comparing a biosimilar to its FDA-approved reference product, there are no clinically meaningful differences in safety, purity, or potency. Like all biologics, biosimilars are tested in accordance with the Current Good Manufacturing Practice regulations enforced by the FDA. For more information about the quality, safety, and effectiveness of #biosimilars, view the new educational resource from FDA and US Pharmacopeia: https://lnkd.in/dPRTAbBR 🇺🇸 🎊 🎉 🧬 #CIASP

Thank you for visiting us at DCAT Week in New York! If you missed us, please feel free to reach out to the Pii team to schedule a call: https://hubs.ly/Q02pNX1d0 Pii is With You Every Phase of the Way! Let's Shape the Future Together! #Pii #DCAT #DCATWeek #FormulationDevelopment #AnalyticalServices #ProcessScaleUp #Scalability #AsepticFilling #Lyophilization #TechTransfer #Manufacturing #Packaging #Steriles #Injectables #OralSolidDose #Softgels #OralSuspensions #Liquids #Pharmaceuticals #Biotech #DrugDevelopment #PharmaManufacturing #QualityControl #RegulatoryCompliance #GMP #PharmaIndustry #Biopharma #PharmaceuticalTechnology #DrugFormulation #DrugDelivery #ContinuousManufacturing #CMC #Validation #ClinicalTrials #SupplyChain #ColdChain #PharmaPackaging #ProductDevelopment

Are you planning to attend ISPE Aseptic Conference 2024? Grab the chance to meet Massimiliano Carriero, Riccardo Bagnari and Patrizia Arcangeli on booth #28, and talk about our aseptic solutions. You will also touch first hand our new AGLTS 2. Book a meeting 👉 https://lnkd.in/dgyBJKBw #TemaSinergie #biopharma #asepticmanufacturing #biotecnologia #testsystems #asepticprocessing #pharmaceuticalmanufacturing #pharmaceuticalindustry #biomedicalengineering #pharmacist #pharma #pharmacy #qa #sterility #sterilitytesting #isolators

A report released by the The Pharmaceutical Security Institute (PSI) found that pharmaceutical crime incidents increased by 38%📈 due to COVID-19.  The COVID-19 pandemic massively interfered with the effort to reduce 💊#SF medicines and medical products, and the repercussion of the pandemic continues to affect this global issue. Learn more in the Fight the Fakes Alliance report here: https://bit.ly/3LIKh5I #FighttheFakes #fakemeds

Difference Between 21CFR Part 11 and EUGMP Annexure 11 #pharma #Sterile #pharmaceuticals #Healthcare #Lifescience #Injectables #pharmamanufacturing #GMP #GLP #Guideline #21cfr #EUGMP #asepticprocessing #aseptic

Q&C Services sees more Health Canada activity than anyone else in Canada due to the sheer number of products we import and the amount we consult with industry. The chart below shows the most frequently cited GMP sections in 2023.   Read the Q&C Services’ full 2023 analysis of Health Canada GMP Drug Inspection in the QuicknoteTM : https://lnkd.in/e-y439zR   See how Q&C services can help improve your processes. https://lnkd.in/gjtUuXi      #gmp, #pharmaceuticals, #qualityassurance, #consulting

MRG is getting ready for RAPS Convergence 2024! As experts in registration in the MENA region, we’re excited to share our knowledge at this key event. Come visit our booth to share with you how MRG can help navigate regulatory pathways. Stay tuned for more updates as we prepare for a great event. #MRG #RAPS #REGULATORYAFFAIRS #SAUDIREGISTRATION #MDMA #EGYPTMEDICALDEVICES #PHARMACEUTICALS

🚨 Webinar Alert🚨 Watch this webinar and discover the latest analytical methods tackling nitrosamines and NDSRIs in pharmaceuticals. Recent FDA and EMA guidelines require monitoring these impurities at ultra-low levels (ng/mL). Ensure the safety of your drug products using the advanced capabilities of Agilent’s LC-MS/MS solutions. 🔬 What You’ll Learn: • The importance of characterizing and quantifying mutagenic impurities. • An improved Multi Residue Method for analyzing 8 nitrosamines in losartan drug products using the Agilent 6495LC/TQ system. • A robust MRM method for quantifying NDSRIs in various drug substances and products using the Agilent 6475 and 6495 LC/TQ systems. 📅 Don’t miss this opportunity to enhance your analytical toolbox and stay ahead in ensuring drug safety and compliance! 👉 Click the link to access the webinar at your convenience: https://bit.ly/3T5Xjyn #Pharma #Nitrosamines #NDSRIs #LCMSMS #SmallMolecule DE-000662