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  6. I have summarized the challenges and solutions for nitrosamine analysis.

I have summarized the challenges and solutions for nitrosamine analysis.

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last updated:Nov 28, 2022

アジレント・テクノロジー株式会社
アジレント・テクノロジー株式会社
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Reliable detection and quantification of nitrosamines and mutagenic impurities.

Due to the presence of unacceptable levels of mutagenic nitrosamine impurities, several pharmaceuticals have recently been recalled. To accurately detect and quantify trace amounts of mutagenic impurities in pharmaceuticals, Agilent offers relevant GC/MS, LC/MS, and high-throughput MS-based analytical techniques. <Challenges in Nitrosamine Analysis> 1. Introducing mass spectrometers requires meeting regulatory requirements, which can be cumbersome. 2. There are many target substances, making it difficult to choose which method/device to use for GC/MS or LC/MS. 3. Due to the high cost of the equipment, results that justify the expense are expected (in terms of cost, operation, speed from introduction to startup, and decisions on outsourcing). 4. It is challenging to foresee whether the risk assessment can be completed by the deadline. <Solutions for Nitrosamine Analysis> Agilent's application guide provides various validated methods from sample preparation to measurement analysis, enabling quick setup and support from introduction to operation. Additionally, regulatory compliance, including data integrity, is achievable.

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I have summarized the challenges and solutions for nitrosamine analysis.

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★ Application guide now available https://www.chem-agilent.com/contents.php?id=1006706 On October 8, 2021, the PMDA issued measures against the risk of nitrosamine contamination in pharmaceuticals. https://www.pmda.go.jp/safety/info-services/drugs/0371.html ★ Webinar on nitrosamine analysis now available https://www.chem-agilent.com/form_webinar/?name=29_22_LCTUES_ES_JA-06

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Points of Analysis for Nitrosamines and Mutagenic Impurities - Focusing on Latest Trends and Analysis Cases -

Points of Analysis for Nitrosamines and Mutagenic Impurities - Focusing on Latest Trends and Analysis Cases -

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Agilent Nitrosamine Analysis Webinar Part 2

Nitrosamine Analysis Webinar Part 2

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As the second installment of the highly acclaimed webinar "Latest Information on Nitrosamine Analysis" held in June last year, we will be hosting an online seminar that focuses on more practical analytical approaches and content directly related to quality control. In this webinar, we will discuss the latest application examples of nitrosamine analysis using the Agilent 6495D LC/TQ, as well as key points regarding data integrity, which has become increasingly important in the pharmaceutical industry. The content is designed to be immediately applicable to the work of those engaged in enhancing the sophistication and reliability of nitrosamine analysis. Target Audience - Pharmaceutical manufacturers considering or conducting nitrosamine analysis - Analysts and lab managers from contract analysis organizations Program - Introduction to the latest nitrosamine analysis techniques using LC/MS - Data integrity required for pharmaceutical impurity analysis

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Frontiers in Biopharmaceutical Analysis - From Basics to Applications by Modality - [Day 3: Oligonucleotide Edition]

Day 3. Oligonucleotide Edition: The Cutting Edge of Biopharmaceutical Analysis - From Basics to Applications by Modality -

  • Seminar・Event

<June 21 (Wednesday) Special Lecture on Oligonucleotides> "Analysis of Impurities in Oligonucleotide Manufacturing" The techniques of HPLC and LC/MS have improved in recent years and have become essential methods for the analysis of oligonucleotides. This presentation will introduce examples of oligonucleotide analysis using 2D-LC/MS and the results of comparisons of the columns used for analysis. Ajinomoto Bio-Pharma Services Ms. Emi Saito, Research and Development Department, GeneDesign Inc. <Program> 1. [Special Lecture] Analysis of Impurities in Oligonucleotide Manufacturing 2. Oligonucleotide Purification 3. Automation and Labor-Saving of Oligonucleotide Analysis using 2D-LC/MS 4. Agilent's Enterprise & Consulting Services

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Frontiers in Biopharmaceutical Analysis - From Basics to Applications by Modality - [Day 1: Antibody Drugs and ADCs]

  • Seminar・Event

<Special Lecture on Antibody Drugs and ADC> Ms. Eriko Numao, Kyowa Kirin Co., Ltd. "New Performance Evaluation Method of Multi-Attribute Method and Future Prospects: From Manufacturing Considerations to Quality Control" This presentation will introduce the results and challenges of performance evaluation using a new method of the Multi-Attribute Method, which has recently gained attention as a new tool for quality evaluation of biopharmaceuticals, as well as future prospects. ---------------- We will hold a three-part webinar series covering analysis fundamentals to applications, divided by modality. <Day 1. Program> Special Lecture "New Performance Evaluation Method of Multi-Attribute Method and Future Prospects: From Manufacturing Considerations to Quality Control" Ms. Eriko Numao, Kyowa Kirin Co., Ltd. Bioproduct Technology Research Institute "End-to-End Workflow for Characterization of Antibody Drugs and ADCs" "Case Studies of HPLC Columns and Multidimensional HPLC Applications for Antibody Drugs" "Automation of Antibody Preprocessing Using Dispensing Machines" "Proposal for Lab DX and Data Integrity Compliance" Agilent Technologies

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Agilent Japan Pharmaceutical Society 143rd Annual Meeting Luncheon Seminar: Challenges in Nitrosamine Analysis and Agilent's LC/MS & GC/MS Solutions

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Establishing a method to accurately analyze nitrosamine impurities, which are carcinogenic substances, is an important challenge. This demonstrates a method for detecting nitrosamines specified by organizations such as the Pharmaceuticals and Medical Devices Agency (PMDA) using Agilent's LC/MS and GC/MS.

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アジレント・テクノロジー株式会社

アジレント・テクノロジー株式会社

Testing, Analysis and Measurement

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Agilent was born out of the Hewlett-Packard Company's spin-off in 1999. Since then, we have received numerous awards related to innovation and have obtained patents for inventions that surpass those accolades. More importantly, the number of customers we serve has been increasing year by year, demonstrating the strength of our partnerships. Agilent has become a leader in the life sciences, diagnostics, and applied chemistry markets. We provide instruments, services, consumables, applications, and expertise to laboratories around the world, contributing to the discovery of insights that our customers are exploring. Through our expertise and reliable collaboration, we offer highly dependable solutions to our customers.

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