Pharmaffiliates Analytics and Synthetics(P) Ltd’s Post

Analytical development professionals: 1. Analytical Feasibility Checklist https://lnkd.in/gwEdCm2H 2. Analytical Quality by Design (AQbD) https://lnkd.in/gm5Q3S-X 3. Key Elements of an Analytical Worksheet https://lnkd.in/gdw-BnDr 4. Analytical Procedure Development https://lnkd.in/de4eqFfZ 5. Different Types of HPLC Columns in Pharmaceutical Analysis https://lnkd.in/dzYUd7ey 6. Analytical Test Method Validation and Verification https://lnkd.in/gWn73J3z 7. Forced Degradation Studies During Method Validation https://lnkd.in/gbPjxBF9 8. Most Common Human Errors in Analytical Laboratories https://lnkd.in/dktAf5ga 9. Analytical Development Report https://lnkd.in/gf9wwuQa 10. Guidance for Analytical Method Transfer https://lnkd.in/guJjVks3 11. USFDA Complaint Laboratory KPIs Measurements https://lnkd.in/db6REHBi 12. Common Interview Questions and Answers on Analytical Development https://lnkd.in/gUszVwFt #Analyticaldevelopment #Pharmaceuticaldevelopment Happy Learning, Students!

Seven Star Pharmaceutical Services (Seven Star) is a technology-driven Contract Research Organization (CRO) that supports drug development programs. We work closely with our clients to ensure comprehensive solutions for their needs in CMC/solid-state chemistry research, crystallization process development, and preformulation studies and formulation development. In addition to these services, we also provide routine analytical testing, CMC consulting, intellectual property support and structure determination from single crystal X-ray diffraction data. Contact us to learn more about our services: https://lnkd.in/eS_tKza #preformulations #formulationdevelopment #DSC #MDSC #TGA #Thermogravimetricanalysis #SingleCrystalXrayDiffraction #SCXRD #pKa #LogP #XRPD #HTdependentXRPD #Analyticallabtesting #pharmaceuticals #CMC #CMCconsulting #pharmaceuticaldevelopment #drugdevelopment #SolidStateChemistry #research #SaltScreening #CrystallizationScreening #Crystallizationprocessdevelopment #CocrystalScreening #PolymorphScreening #chemistry #MedicinalChemistry #materialsscience #analyticalresearch #materialsresearch #cdmo #CRO #contractresearch #drugdiscovery #api #crystalform #SyntheticOrganicChemistry #entrepreneurship

🚀 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

With the recent availability of benchtop #NMR systems, NMR-based Quality Control (QC) procedures are now more attractive than ever, especially in the new context of Analytical Quality By Design (AQbD). Learn more about all the versatility and robustness of NMR tailored for pharmaceutical QC: https://lnkd.in/dkQJpMRg #QualityControl #Pharma #PharmaIndustry #PharmaceuticalQuality

Table Top Shakers: Applications: Mixing and Blending: Ideal for achieving homogeneous mixtures of various chemical or biological samples, ensuring consistent results in laboratory procedures. Cell Culture: Provides precise and gentle shaking required for the growth and maintenance of cell cultures, enabling high-quality experimental outcomes. Chemical Reactions: Ensures controlled agitation for chemical reactions, aiding in faster reaction times and better interaction between reagents. Sample Preparation: Helps in the preparation of biological, chemical, or pharmaceutical samples, offering efficient and accurate pre-processing. Pharmaceutical Testing: Supports reliable testing and formulation procedures for pharmaceutical products, maintaining accuracy and consistency in the lab. Fo r more details visit www.labnlife.com #mixingandblending #cellculture #chemicalreactions #samplepreparation #pharmaceuticaltesting #laboratoryequipment #precisionresearch #labnlife #innovationinlabs

At the heart of our operations is an advanced R&D lab, powered by a team of expert chemists with over 100 years of combined industrial experience. Specialising in the synthesis and process optimisation of complex specialty molecules, we are leaders in developing specialty small molecules and API intermediates, setting new standards in the pharmaceutical industry. Our unwavering commitment to quality, precision, and efficiency drives us to design and manufacture intricate molecular structures that serve as essential building blocks for the pharmaceutical sector. From custom synthesis and process optimization to creating novel intermediates, we deliver tailored, high-quality solutions that meet the unique needs of our clients. Partner with us to shape the future of the pharmaceutical and chemical industries through innovation and excellence. #InnovationInChemistry #PharmaceuticalExcellence #RDLeadership #SpecialtyMolecules #APIIntermediates #CustomSynthesis #ProcessOptimization #ChemicalInnovation #QualityAndPrecision #PharmaSolutions #ChemicalExcellence #MolecularResearch #IndustrialChemistry #PharmaceuticalIndustry #PartnerInInnovation

What Is #ADL (Analytical Development Laboratory ) in Pharmaceutical industries.💊 In the pharmaceutical industry, an #Analytical #Development #Laboratory (#ADL) plays a crucial role in the development and quality control (#QC)of pharmaceutical products. # Definition An Analytical Development Laboratory is a facility responsible for #developing, #validating, and #implementing analytical methods for pharmaceutical products. These methods are used to test the #identity, #purity, #potency, and performance of pharmaceutical products. # Responsibilities The ADL is responsible for: 1. #Methoddevelopment: Developing and optimizing analytical methods for pharmaceutical products, including chromatographic, spectroscopic, and other techniques. 2. #Methodvalidation: Validating analytical methods to ensure they are accurate, precise, and reliable. 3. #Stabilitytesting: Conducting stability testing to determine the shelf-life of pharmaceutical products. 4. #Releasetesting: Performing release testing to ensure pharmaceutical products meet regulatory requirements. 5. #Troubleshooting: Investigating and resolving analytical issues related to pharmaceutical products. 6. #Technologytransfer: Transferring analytical methods and technology to other laboratories or manufacturing sites. # Activities The ADL performs various activities, including: 1. High-Performance Liquid Chromatography (#HPLC)_ 2. Gas #Chromatography (#GC)_ 3. Mass #Spectrometry (#MS)_ 4. Nuclear Magnetic Resonance (#NMR) spectroscopy_ 5. Infrared (#IR) spectroscopy_ 6. #Dissolution testing_ 7. #Disintegration testing_ 8. Particle size analysis_ # Benefits The ADL provides several benefits to pharmaceutical companies, including: 1. Improved product #quality 2. Increased #efficiency 3. Reduced costs 4. Enhanced regulatory compliance 5. Faster time-to-market # Regulatory Requirements The ADL must comply with various regulatory requirements, including: 1. #USFDA regulations 2. #EUGMP guidelines 3. #ICH guidelines 4. #ASTM standards 5. #ISO standards In summary, the Analytical Development Laboratory plays a vital role in ensuring the #quality and #safety of #pharmaceutical products. Its activities and responsibilities are critical to the development, manufacturing, and release of pharmaceutical products. #QC #chemistry #QA #Qualitycontrol #Qualityassurance #Analyticalchemistry #Pharma #validation #Research

The collection of documented evidence that a pharmaceutical laboratory instrument performs suitably for its intended purpose and, according to USP General Chapter <1058>, is a four-part process. 1. Design Qualification (DQ) 2. Installation Qualification (IQ) 3. Operational Qualification (OQ) 4. Performance Qualification (PQ) #USP #Pharma #analytical #analyticalinstrument #engineeringjobs #engineering #dissolution #tmpl #labindia

The Power of Analytical Testing in Ensuring Drug Quality In pharmaceutical QC, precise and accurate analytical testing is essential. Techniques like HPLC, GC, UV, and FTIR help detect impurities, measure potency, and ensure uniformity. 📊 Analytical testing plays a critical role in: Assay determination Content uniformity (CU) Dissolution and dissolution profile testing Identification of related substances Accurate data from these tests ensures that products are safe and effective for patient use. What are the go-to techniques in your lab? #QualityControl #HPLC #AnalyticalChemistry #PharmaQC #DissolutionTesting #MdAbdullahAlMahmud #Pharmaceuticals #GMP #GLP #FDACompliance

Elemental impurities in drug products may arise from several sources, e.g., catalysts, manufacturing processes (including drug substances) or excipients used, container closure systems. Since elemental impurities do not provide any therapeutic benefits, their levels in drug product should be controlled within acceptable limits. The ICH guideline Q3D on elemental impurities was adopted by constantly increasing attention towards drug product safety. The exposure level should be established for each element – Permitted Daily Exposure (PDE). The elements are placed into three classes, based on their toxicity (PDE) and occurrence likelihood in the drug product :- Class 1: As, Cd, Hg, and Pb Class 2A : Co, Ni and V Class 2B : Ag, Au, Ir, Os, Pd, Pt, Rh, Ru, Se and Tl Class 3 : Ba, Cr, Cu, Li, Mo, Sb, and Sn. Other elements with PDE not established: Al, B, Ca, Fe, K, Mg, Mn, Na, W and Zn. Pharmaffiliates capabilities and expertise in metal contamination approach covers the following areas: ◾ Complex samples matrix preparation/ mineralization method establishment against impurity level determination ◾ Non-GMP screening determination of elemental impurities level in drug product for risk assessment and quality control purposes; comprehensive elemental impurities of 1, 2A, 2B and 3 classes and other elements can be examined, using ICP-MS & ICP-OES system ◾ Analytical methods development with limits corresponding to PDEs level requirements, ICP-MS or ICP-OES ◾ Analytical method verification/validation in line with cGMP regulations, ICP-MS or ICP-OES ◾ Drug products cGMP batch release testing #ICPMS #ICPOES #metalanalysis #elemental #analysis #ichq3d #PDE #testing #pharmaffiliates #pharmaceutical #nonpharmaceuticals #referencestandards #impurities #elementalimpurities #sampleanalysis #methoddevelopment #methodvalidation #batchanalysis #methodfeasbility #methodverification