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Author name: lara.james

Hi, I'm Lara, and I work within the Marketing team at Lhasa Limited. I have a masters degree and PhD in Chemistry.

ICH M7 control option 4

ICH M7 control option 4: How to confidently demonstrate control of mutagenic impurities in API synthesis (without analytical testing)

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If you’re currently relying solely on analytical testing to check for mutagenic impurities in your active pharmaceutical ingredient (API), there is a more time- and cost-effective option available that doesn’t compromise patient safety. Recent data for a medium-sized pharmaceutical company showed that you could save $1.35M annually and reduce time taken by 77%, using in […]

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From forced degradation to innovation: Your Science of Stability 2025 conference recap

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The Science of Stability (SoS) 2025 conference, recently held in Philadelphia, brought together leading experts from the pharmaceutical industry and academia. Co-hosted by Lhasa Limited and FreeThink Technologies, this year’s event was a hub for collaboration and discussions. Attendees consistently praised the conference’s thematic structure and unparalleled networking opportunities, with many reporting a significant ‘increase in knowledge surrounding stability

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How to overcome the critical challenges faced in forced degradation studies

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At Lhasa we know that there are many challenges involved in carrying out risk assessments for drug substances and drug products, to ultimately ensure a safe and effective product for patients. Forced degradation studies are essential in pharmaceutical development to assess drug stability and ensure product quality and safety. These studies help identify degradation pathways,

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Anvisa RDC 964/2025: What you need to know about the latest regulatory update

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The Brazilian Health Regulatory Agency (Anvisa) has introduced RDC 964/2025, a new guidance that outlines in more detail the requirements for conducting forced degradation studies. This new regulation replaces RDC 53/2015, aligning the requirements for forced degradation studies with international (ICH) standards. By reacting to these regulatory changes, Lhasa has evolved our solution for predicting

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10 FAQs About Mirabilis: Pharmaceutical Impurity Control Using In Silico Tools

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Identification and control of impurities in active pharmaceutical ingredients (APIs) and pharmaceutical drug products is critical in drug development. Mirabilis is our innovative solution designed to address this challenge. In this post, we’ll answer ten frequently asked questions about Mirabilis.   What is Mirabilis? Mirabilis is an in silico tool developed by Lhasa Limited that

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degradation and nitrosamine risk assessment webinar blog cover image

Did you miss our webinar on degradation chemistry and nitrosamine risk assessment? Here are 5 top takeaways!

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If you couldn’t join us for our recent webinar, “Identifying the Formation of Nitrosamines via Degradation Pathways Using an In-Silico Approach,” we’ve got you covered! We explored how Zeneth, our cutting-edge software solution, can help you detect potential degradation issues early in the drug development workflow, specifically in the context of nitrosamine risk assessment. We

Did you miss our webinar on degradation chemistry and nitrosamine risk assessment? Here are 5 top takeaways! Read More »

zeneth blog 1

Have you read this? Benchmarking In silico prediction of pharmaceutical degradation pathways

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We are delighted to share our important new open access article: In silico prediction of pharmaceutical degradation pathways: A benchmarking study using the software program Zeneth. The paper, recently published in Organic Process Research & Development (OPRD) is authored by Lhasa Principal Scientist Rachel Hemingway, alongside industry expert co-authors from AstraZeneca, GSK, Pfizer, BMS, Amgen

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zeneth blog

Safeguarding Pharmaceutical Development: The Importance of Early Risk Mitigation

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Ensuring the safety and efficacy of active pharmaceutical ingredients (APIs) is of paramount importance. A critical aspect of this process involves the identification and mitigation of potentially mutagenic impurities, like nitrosamines. In this blog, we will explore the significance of risk mitigation at the early stages of API development and introduce a cutting-edge solution, Zeneth,

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How well do you know your synthetic process?

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Unreported changes to synthetic processes lead to the surprise presence of nitrosamine impurities in marketed drug products. This discovery resulted in the recall of several hypertension, heartburn, and diabetes medications. The nitrosamines crisis While many impurities are introduced directly as reagents, potentially mutagenic impurities (PMIs) arising during manufacture can be harder to identify as they

How well do you know your synthetic process? Read More »