Impurity reference standards
Gabapentin impurities & reference standards
Characterised Gabapentin impurities, degradation products and related compounds for analytical method development, validation, QC release and regulatory filings.
62reference materials
1nitrosamine impurities
3isotope-labelled
COAHPLC · NMR · MS on request
Parent API: Gabapentin
60142-96-3 · C9H17NO2
FAQs — Gabapentin impurities
Which Gabapentin impurities do you supply?
We list 62 Gabapentin-related reference materials, including process impurities, degradation products, nitrosamine impurities, stable-isotope-labelled standards and related compounds. Each is supplied with a COA, and characterisation data (HPLC, 1H-NMR, MS, IR) can be provided on request.
What are Gabapentin impurity standards used for?
They are used for analytical method development and validation, impurity identification and quantification, forced-degradation and stability studies, and to support ANDA, DMF and other regulatory submissions under ICH Q3A/Q3B (and ICH M7 for mutagenic impurities).
Can you synthesise a Gabapentin impurity that is not listed?
Yes. Our custom synthesis service can prepare and characterise unlisted impurities, metabolites and labelled analogues from milligram to gram scale. Share the structure or name and required quantity for a quotation.
Request Gabapentin impurity standards
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