GEN-MKT-18-7897-A
Oct 10, 2024 | Blogs, Pharma, QTRAP / Triple Quad | 0 comments
Nitrosamines are a large group of N-nitroso compounds that share a common functional N-N=O group. They are produced by a chemical reaction between a nitrosating agent and a secondary or tertiary amine. Back in 2018, nitrosamines suddenly found themselves in the spotlight when they were unexpectedly detected in medications for high blood pressure. Since then, they have been found in several other prescription medications, including those for heartburn, acid reflux and diabetes, resulting in manufacturers recalling some common medications.
Here are a few examples of how SCIEX solutions can help support the development and manufacturing of pharmaceutical drugs with these analytes.
BH is an H1 receptor agonist and an H3 receptor antagonist, which can be chemically synthesized. The structure of BH includes a secondary amine, which is more reactive in the formation of nitrosamines than the tertiary amines. The regulation has amended the maximum permissible daily intake limit for NNBH as 18 ng/day which is equivalent to a maximum daily dose of 48 mg/day. Given that BH has a maximum daily dose of 48 mg/day, a nitrosamine limit of 0.375 ng/mg is required to be quantified in the API. This technical note presents a reliable workflow for the identification and sensitive quantitation of NNBH in BH API below the calculated specification limit using the QTRAP 4500 system.
Read more, here >
Orphenadrine citrate (OC) is an anticholinergic drug of the etholamine antihistamine class, which can be chemically synthesized. OC has a secondary amine in the structure, which is more reactive in the formation of nitrosamines than the tertiary amines. The regulation has amended the maximum permissible daily intake limit for NNDO as 18 ng/day which applies to a maximum daily dose of 200 mg/day. Given that OC has a maximum daily dose of 200 mg/day, a nitrosamine limit of 90 pg/mg is required to be quantified in the API.
This technical note presents a reliable workflow for the identification and sensitive quantitation of NNDO in OC API below the calculated specification limit using the QTRAP 7500 system.
Read more, here>
SCIEX OS software is a GxP compliance-ready solution integrating data acquisition with the SCIEX time-of-flight mass spectrometers and the SCIEX triple quadrupole systems. Learning just one software allows even less experienced MS users to be trained rapidly to acquire and convert raw MS data into product quality attribute results. The software offers ample flexibility in defining security settings by allowing the creation of customized user roles with different levels of access to the software’s control. Comprehensive and easily readable audit trails guarantee traceability and data integrity.
If you are looking for more information about analyzing nitrosamine impurities by LC-MS, discover our Spotlight on series in which we highlight a different challenging molecule or class of compounds and related LC-MS solutions. Find out more about the nitrosamines featured here.
In biopharmaceutical development, sequence variants (SV) are considered an inherent risk of producing complex proteins in living systems. Sequence variants are unintended changes to the amino acid sequence of a biotherapeutic and can be caused by errors in transcription or translation in the host cell, or cell culture and process conditions. Detailed analysis of SVs is important in process and product development to ensure the drug’s safety and efficacy. Even low‑level sequence variants can have significant implications for product quality, safety, and efficacy, making their accurate detection and characterization a critical requirement across development, process optimization, and regulatory submission.
CE‑SDS remains a cornerstone assay for characterizing fragmentation, aggregation, and product‑related impurities in therapeutic proteins. UV detection has been the long‑standing standard. However, it frequently struggles with baseline noise, limited sensitivity for minor fragments, and subjective integration.
At SCIEX, innovation doesn’t stop at instruments; it extends to how you interact with your LC-MS/MS or CE systems every day. That’s why we’re excited to introduce the SCIEX Now spring 2026 improvements: a set of meaningful enhancements shaped directly by your feedback.
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