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Negative peaks in UV detection, particularly in HPLC occur due to several reasons: Solvent Absorption: If the mobile phase (solvent) absorbs more UV light than the sample, it can cause a negative peak when the sample elutes. Baseline Drift: Changes in the baseline due to temperature fluctuations or changes in the mobile phase composition can result in negative peaks. Sample Matrix Effects: Components in the sample matrix that absorb UV light differently than the analyte can lead to negative peaks. Detector Saturation: If the detector is saturated with a high concentration of a compound, it might show a negative peak for subsequent compounds. #Chromatography #Chemistry #Science #Chemist #Scientist #GMP #GLP #QC #QA #Quality #TQM #QMS #RnD #Validation #Analytical #Development  #Research #Pharmaceuticals #Inspire #Pharma #USP #EDA #BP #ICH #FDA #WHO #Dissolution #UV #Safety #Risk

Regulatory Affairs Insight: 3.2.S.1General Information. In the Common Technical Document (CTD) structure for drug submissions, section 3.2.S.1 is a critical part of Module 3, specifically covering General Properties of the Drug Substance. Here’s a breakdown of what this section typically includes: 1. Nomenclature: - Name(s): The chemical, generic (INN), and brand names of the drug substance. - Synonyms: Any known alternative names or synonyms. - Chemical Abstracts Service (CAS) Number: The unique numerical identifier for the chemical. - IUPAC Name: The scientific naming according to International Union of Pure and Applied Chemistry. 2. Structure: - Molecular Structure: Typically presented as a two-dimensional chemical structure. - Molecular Formula: Notation that represents the type and number of atoms. - Molecular Weight: Average or exact molecular mass of the compound. 3. General Properties: - Physical Properties: Such as appearance, color, form (e.g., crystalline, powder). - Solubility: Solubility in various solvents like water, ethanol, and others. - Melting/Boiling Points: If applicable to the substance. - pKa Values: Important for determining ionization properties. - Optical Activity: Specific rotation for chiral molecules. - Hygroscopicity: Tendency to absorb moisture, which affects storage conditions. - Polymorphism: Any polymorphic forms that might exist, which can affect stability and efficacy. - Partition Coefficient: Generally log P, which gives insight into lipophilicity. Importance in Regulatory Affairs Section 3.2.S.1 provides the foundation for understanding the physical and chemical characteristics of the drug substance. These properties are vital for assessing stability, storage conditions, and potential impurities. They also help in ensuring consistent quality across different batches and are essential for regulatory reviewers when assessing the suitability of the drug substance for therapeutic use. #ctd #regulatory #cmc #ema #tmda #nafdac #pharmaceutical #osd #dmf #drug #dossier

Elemental impurities in drug products may arise from several sources. The main source of contamination are equipment and utensils used in processing, holding, transferring, and packaging. A second source can be residual metals used as process catalysts. Since elemental impurities pose a risk to patient health due to toxicological effects, element impurity levels should be controlled within acceptable limits in a drug product. Analyzing elemental impurities presents a challenging task due to the need to quantify ultra-low levels of these impurities across diverse and complex matrices, followed by the validation of developed methods to ensure compliance with GMP requirements.   VitelyBio is fully equipped with ultra-modern instrumentation, such as ICP-MS systems, to effectively analyze the levels. To learn more or any business inquiry, write to Yogesh Chaudhari: info@vitely.com or ychaudhari@vitely.com #pharmaceuticals #analyticalservices #invitro #invivo #clinicaltrials #clinicalresearch #bindingstudy #vitelybio #drugs

Best Practices for Analytical Method Transfer Between Sites   First, a TRANSFER PROTOCOL defining the acceptable assay equivelance between sites is a must, together with a risk assessment. Acceptance criteria is provided from the experiments with Drug substance (DS) and drug Product (DP) performance in the specified assay. There might be a need for improvement of the samples to support the assays’ upper and lower limit ranges required for testing.   Equivalency testing using identical samples at each site is very much recommended to be included in the Transfer Protocol. Avoid making changes to the assay during transfer as much as possible.   If manufacturing will be conducted in multiple sites, a single reference site is recommended for all assay transfers. A robust trend monitoring will help identifying issues/shifts during transfers. After initial validation shifts may occur over time or during transfer to a new test site. Having trend monitoring will save asay from running out od specifications; which can be costly.      

Why Choose 8mm HPLC Vials? Our 8mm HPLC vials are designed to meet the demands of modern laboratory applications. With their precise dimensions and superior quality, these vials ensure optimal sample containment, prevent contamination, and maintain sample integrity throughout the analysis process. Whether you're working on pharmaceutical, environmental, or forensic research, our 8mm HPLC vials are the perfect choice to achieve accurate and reproducible results. Explore the Diverse Applications: Pharmaceutical Research: Ensure the efficacy and safety of drug formulations with our 8mm HPLC vials. They provide secure storage of sensitive samples, such as drug solutions, allowing you to confidently analyze compounds and maintain regulatory compliance. Environmental Analysis: Detect and quantify environmental pollutants with ease using our 8mm HPLC vials. These vials are ideal for analyzing water, soil, and air samples, enabling you to contribute to a healthier and cleaner planet. Forensic Science: Solve complex criminal investigations efficiently by utilizing our 8mm HPLC vials. These vials ensure the preservation of crucial evidence samples, enabling accurate identification and analysis of substances for forensic applications.

Certificate of Analysis (CoA) and Characterization Data: All products are provided with a certificate of analysis (CoA) along with the characterization data like 1H-NMR, MASS, HPLC Purity, MSDS, etc. (whatever relevant and possible). Moreover, additional data like 13C-NMR, 13C-DEPT NMR, GC, GC-MS, IC, Potency, TGA, etc. will be provided on request (extra charges may apply).  This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. This product provided by Karpschem is generally used for Abbreviated New Drug Application (ANDA) filing to FDA, toxicity study of respective drug formulation, Quality Control (QC) and analytical studies during commercial production of the API]. Please also find out process impurities, degradation impurities, potential impurities of related api/drug developed by our R&D. Products provide by Karpschem are for research and development (R&D) use only If you need different pack size / quantity, please contact us or email us at info@karpschem.in

Certificate of Analysis (CoA) and Characterization Data: All products are provided with a certificate of analysis (CoA) along with the characterization data like 1H-NMR, MASS, HPLC Purity, MSDS, etc. (whatever relevant and possible). Moreover, additional data like 13C-NMR, 13C-DEPT NMR, GC, GC-MS, IC, Potency, TGA, etc. will be provided on request (extra charges may apply).  This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. This product provided by Karpschem is generally used for Abbreviated New Drug Application (ANDA) filing to FDA, toxicity study of respective drug formulation, Quality Control (QC) and analytical studies during commercial production of the API]. Please also find out process impurities, degradation impurities, potential impurities of related api/drug developed by our R&D. Products provide by Karpschem are for research and development (R&D) use only If you need different pack size / quantity, please contact us or email us at info@karpschem.in

CHEMICAL REACTIONS: OVERVIEW - This Module is aimed at operations personnel in API manufacturing and provides an overview of how chemical reactions are carried out and the various process variables that must be controlled. Follow SKILLPAD - digital learning for life sciences on LinkedIn at https://lnkd.in/eZt4kHw for more news and updates. Description and screenshots here: https://lnkd.in/eA4w7FJD Schedule your DEMO here: info@skillpad.com #pharma #apimanufacturing #biopharma #chemicalreactions #reactors

𝐈𝐂𝐇 𝐐𝟐(𝐑𝟐) 𝐕𝐚𝐥𝐢𝐝𝐚𝐭𝐢𝐨𝐧 𝐨𝐟 𝐚𝐧𝐚𝐥𝐲𝐭𝐢𝐜𝐚𝐥 𝐩𝐫𝐨𝐜𝐞𝐝𝐮𝐫𝐞𝐬 - 𝐒𝐜𝐢𝐞𝐧𝐭𝐢𝐟𝐢𝐜 𝐠𝐮𝐢𝐝𝐞𝐥𝐢𝐧𝐞 The new version of November 2023 comes into force in June 2024 in the European Medicines Agency environment. It incorporates specific aspects of some techniques, such as LC/MS. Please feel free to contact us to find out more about our method development and validation service! #ICHGuideline #ICH #Impurities #ICHQ2 #Validation #AnalyticalProcedures #Accuracy #Precision #Biopharma #Pharma #DrugDevelopment #DrigDiscovery #Drugs #EMA https://lnkd.in/d83P6R8d

Certificate of Analysis (CoA) and Characterization Data: All products are provided with a certificate of analysis (CoA) along with the characterization data like 1H-NMR, MASS, HPLC Purity, MSDS, etc. (whatever relevant and possible). Moreover, additional data like 13C-NMR, 13C-DEPT NMR, GC, GC-MS, IC, Potency, TGA, etc. will be provided on request (extra charges may apply).  This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. This product provided by Karpschem is generally used for Abbreviated New Drug Application (ANDA) filing to FDA, toxicity study of respective drug formulation, Quality Control (QC) and analytical studies during commercial production of the API]. Please also find out process impurities, degradation impurities, potential impurities of related api/drug developed by our R&D. Products provide by Karpschem are for research and development (R&D) use only If you need different pack size / quantity, please contact us or email us at info@karpschem.in