Jian Wang’s Post

In Active Pharmaceutical Ingredient (API) synthesis, implementing Process Analytical Technology (PAT) is not always a simple decision. Monitoring and understanding a chemical reaction through PAT can include aspects such as: 🔬 Reaction: Understanding the specific chemistry and behavior of the molecule. ⚙️ Equipment: Choosing the right tools and technologies for accurate monitoring. 📈 Application: Implementing PAT in a way that suits the practical requirements of your project. Experts are developing this list and sharing their thoughts about what we can learn from other industries to apply to continuous manufacturing. Read the discussion and deepen your understanding of monitoring and understanding chemical reactions through PAT by joining the API Group on the Continuous Manufacturing Knowledge Center! 🌟 https://ow.ly/qRGT50RPvKK 🌟 #PharmaInnovation #APISynthesis #ContinuousManufacturing

At Dr. Reddys, we are excited to share the exceptional outcome of our relentless efforts in Sugammadex API development. Our commitment to innovation and dedication to excellence have led to significant milestones that promise to revolutionise the pharmaceutical landscape. ● The outcome of our Sugammadex API development: ● Consistent API quality (Purity > 99%) and compliance with ICH1 quality ● Identified, characterised, and synthesised nearly 18 complex impurities. ● Advanced analytical tools (React IR, Raman spectroscopy, FBRM for real-time particle size analysis, etc.) and techniques used for process development. ● Innovative chromatographic purification technique adopted to achieve the highest quality (Purity >99%) ● State-of-the-art manufacturing facility designed to handle sensitive information. ● Strict facility controls in place to control the microbial load essential for sterile injectables. To understand our product better, read the white paper here: https://rb.gy/0o53yu #DrReddysXSustainability #GoodHealthCantWait #WeAreDrReddys #DrReddysAPI #ESG #Sustainability #APIPartner #Pharmaceuticals #SugammadexAPI

Pharmaceutical filter membranes play a vital role in sterile filtration, clarification, and purification processes. They effectively remove particulates, microorganisms, and impurities while allowing the passage of desired components. Visit us at https://lnkd.in/df6P6zYa #PharmaFilterMembranes #SterileFiltration #Clarification #Purification #PharmaceuticalProcessing #ParticleRemoval #MicrobialControl #MembraneTechnology #laboratory #materialscience #materials #m19 #materialengineering #materialtesting #materiallab #researchanddevelopment

🚀 GC/MS Residual Analysis GC/MS Analysis (also called Gas Chromatography/ Mass Spectrometry) is an analytical process that utilises the capabilities of Mass Spectrometry and Gas Chromatography in order to determine the chemical compounds within a sample. GC/MS Analysis are recognised for being one of the most highly reliable and effective analysis for the pharmaceutical, Biotechnology & Medical Device industries. GC/MS Analysis are also preferable for chemical compounds with low limits of detection. Our customers use our GC/MS Analysis to analysis sample in any size chemical state particularly when sample quantity is restricted. GC/MS Residual Analysis is crucial primarily for safety reasons. Residual solvents can be harmful or toxic. Even if they are not directly harmful, they can react with other substances in the product to form harmful compounds. Therefore, it’s essential to identify and quantify them to ensure the safety of the product. Additionally, the presence of residual solvents can affect the quality of the product. They can cause changes in color, consistency, stability, and odor. By identifying and quantifying these solvents, manufacturers can maintain the quality of their products. Regulatory bodies such as the FDA and EMA have set limits on the levels of residual solvents that are permissible in pharmaceutical products. GC/MS Residual Analysis helps manufacturers comply with these regulations and avoid penalties. Our laboratory works according to ISO 17025 (current version) and is accredited since 2008 by the Swiss Accreditation Service (SAS). All testing can be performed according to European or US pharmacopeias. 🎯 To learn more about Medistri’s GC/MS Residual Analysis, visit on our website https://buff.ly/3QJdjVQ or directly contact our team at contact@medistri.swiss. 🌐 Learn more: buff.ly/4cQmflI - The Medistri Team #Medistri #LaboratoryServices

🚀 GC/MS Residual Analysis GC/MS Analysis (also called Gas Chromatography/ Mass Spectrometry) is an analytical process that utilises the capabilities of Mass Spectrometry and Gas Chromatography in order to determine the chemical compounds within a sample. GC/MS Analysis are recognised for being one of the most highly reliable and effective analysis for the pharmaceutical, Biotechnology & Medical Device industries. GC/MS Analysis are also preferable for chemical compounds with low limits of detection. Our customers use our GC/MS Analysis to analysis sample in any size chemical state particularly when sample quantity is restricted. GC/MS Residual Analysis is crucial primarily for safety reasons. Residual solvents can be harmful or toxic. Even if they are not directly harmful, they can react with other substances in the product to form harmful compounds. Therefore, it’s essential to identify and quantify them to ensure the safety of the product. Additionally, the presence of residual solvents can affect the quality of the product. They can cause changes in color, consistency, stability, and odor. By identifying and quantifying these solvents, manufacturers can maintain the quality of their products. Regulatory bodies such as the FDA and EMA have set limits on the levels of residual solvents that are permissible in pharmaceutical products. GC/MS Residual Analysis helps manufacturers comply with these regulations and avoid penalties. Our laboratory works according to ISO 17025 (current version) and is accredited since 2008 by the Swiss Accreditation Service (SAS). All testing can be performed according to European or US pharmacopeias. 🎯 To learn more about Medistri’s GC/MS Residual Analysis, visit on our website https://buff.ly/3zATkmt or directly contact our team at contact@medistri.swiss. 🌐 Learn more: buff.ly/4cQmflI - The Medistri Team #Medistri #Repost

🔬 [𝗟𝗔𝗕 𝗖𝗔𝗦𝗘 𝗦𝗧𝗨𝗗𝗬] - Aspen API: Optimizing Crystallization to Achieve Ideal Particle Size Distribution (PSD) Without Micronization Discover how 𝗔𝘀𝗽𝗲𝗻 𝗔𝗣𝗜, a leading global supplier of active pharmaceutical ingredients (APIs), partnered with Secoya Technologies to transform its crystallization process. This collaborative research project aimed to achieve a consistent and reproducible PSD, eliminating the need for micronization—a critical step often hindered by the sticky nature of certain APIs. 👉 Read the full case study: https://lnkd.in/e7C9Pgjh #API #crystallization #SCT #particle #engineering

Pharmaceutical filter membranes play a vital role in sterile filtration, clarification, and purification processes. They effectively remove particulates, microorganisms, and impurities while allowing the passage of desired components. Visit us at https://lnkd.in/df6P6zYa #PharmaFilterMembranes #SterileFiltration #Clarification #Purification #PharmaceuticalProcessing #ParticleRemoval #MicrobialControl #MembraneTechnology #laboratory #materialscience #materials #m19 #materialengineering #materialtesting #materiallab #researchanddevelopment

Today we talk about #Extractables and #Leachables! The analysis of Extractables & Leachables is essential to ensure the safety of pharmaceutical products. These compounds can affect the stability, efficacy and safety of final products, and their presence must be monitored and quantified to comply with regulations and ensure product quality.   Volatile, semi-volatile, non-volatile, and inorganic extractables are then identified by our organic chemistry scientists using an array of hyphenated #MassSpectrometric instruments and specific libraries and software tools: HS-GC-MS, GC-MS, HPLC-DAD-QTOF, ICP-MS, Preparative HPLC, FT-IR, NMR. At #AMSbiopharma, we are committed to providing accurate and reliable #analysis to help our clients meet regulatory #standards and ensure the safety of their #pharmaceutical products. Contact us today to learn more about how we can help optimize safety in your pharmaceutical development process! #ExtractablesAndLeachables #PharmaceuticalDevelopment #AnalyticalServices #DrugDevelopment #Drugs #Pharma https://lnkd.in/eauHqfzg

At Solvias, we synthesize on demand isotope-labeled nitrosamine reference standards to enable accurate detection and quantification of nitrosamine impurities in pharmaceuticals, ensuring safety and regulatory compliance. Key Benefits: ✔️Automated Synthesis: Streamlined production with prebatched vials containing nitrosylation reagents. ✔️ Optimal Conditions: Parallel scouting ensures ideal synthesis conditions. ✔️ Unmatched Purity: Inert processing and advanced chromatography deliver reference standards of exceptional purity. ✔️ Comprehensive Characterization: Rigorous testing confirms identity, purity, and concentration, guaranteeing reliability. ✔️ Fast Turnaround: API reference standards in 2-3 weeks, with expert support every step of the way. To delve deeper into the high-stakes nature of nitrosamine impurities in APIs, Solvias has published a white paper offering insights and strategies for proactive risk management. 🔍 Read for Free Now: https://lnkd.in/ejMui2G3 📩 Interested in learning more? Reach out at info@solvias.com for further information and discover how we can support your compliance and safety efforts.