Press release
Lactitol Impurity Standards for High-Precision Pharmaceutical Analysis | Aquigen Bio
Aquigen Bio offers high-purity Lactitol impurity standards, fully characterized and ready to support your analytical and regulatory workflows.
Why Lactitol Impurity Standards Are Important
Lactitol is a sugar alcohol used in various pharmaceutical formulations, particularly as a laxative or low-calorie sweetener in diabetic-friendly products. As with any active pharmaceutical ingredient (API) or excipient, controlling impurities is key to ensuring patient safety and complying with ICH Q3A/B guidelines.
Impurities in Lactitol may result from:
https://aquigenbio.com/product/lactitol-ep-impurity-a/
Synthetic routes
Degradation during storage
Manufacturing by-products
To ensure regulatory compliance, these impurities must be identified, quantified, and validated using reference standards.
What Aquigen Bio Offers
Aquigen's Lactitol impurity standards are:
Pharmacopeial-grade and suitable for regulatory submissions
https://aquigenbio.com/product/lactitol-ep-impurity-b/
Supplied with detailed Certificate of Analysis (CoA)
Characterized using HPLC, NMR, and Mass Spectrometry
Globally shipped with full documentation and technical support
Our standards are ideal for use in:
Analytical method development (AMV)
Quality control (QC)
https://aquigenbio.com/product/lactitol-ep-impurity-e/
Stability testing
Regulatory filings (NDA, ANDA, DMF)
Explore more at:
https://aquigenbio.com/products/impurity-standards/lactitol/
Who Uses Our Standards?
Our Lactitol impurity reference standards are used by:
Generic drug manufacturers
Pharmaceutical R&D labs
CROs (Contract Research Organizations)
Quality control laboratories
Regulatory affairs departments
Whether you're preparing for a regulatory submission or performing routine quality checks, Aquigen Bio's standards give your team the confidence and precision required in every assay.
Request Your Quote or Sample Today
Backed by technical expertise and customer-centric service, Aquigen Bio is a trusted partner for pharmaceutical reference standards, impurities, and metabolites.
Aquigen Bio Sciences
281/1, Plot No 41,
Hinjawadi - Pirangut Rd,
Kasar Amboli, Pirangut,
Pune, Maharashtra 412108
Visit: www.aquigenbio.com
Aquigen Bio is a leading provider of certified reference standards, impurity profiling compounds, and research chemicals to pharma, biotech, and academic institutions worldwide. With a dedication to excellence and a focus on regulatory readiness, Aquigen empowers scientists to innovate with confidence.
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