We provide impurity reference standards, custom synthesis, and complete analytical solutions for the pharmaceutical registration process. ISO-certified laboratories, complete documentation, globally trusted.
Guangzhou Lanning Biotechnology Co., Ltd. is a technology-driven enterprise focused on developing impurity reference standards for pharmaceutical registration. We provide custom synthesis, preparative separation, and comprehensive impurity research solutions.
With our own R&D laboratory and quality inspection department, we ensure controllable quality and complete analytical documentation including COA, H-NMR, C-NMR, MS, HPLC, UV, and IR spectra.
State-of-the-art laboratories and equipment
High-purity impurity reference standards across 7 major categories
Cefuroxime, Cefotaxime, Ceftriaxone and more
Amoxicillin, Ampicillin, Dicloxacillin and more
Meropenem, Imipenem, Ertapenem and more
Aztreonam, Fusidic acid, Doxycycline and more
Vitamin impurities, Famotidine, Daclatasvir
New hot products — complete validation support
Pharmaceutical standard reference materials
Browse our full catalog of reference standards
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Contact us today for a quote on high-purity impurity reference standards.
Contact Us Now →Quick answers about impurity reference standards for pharmaceutical registration
Impurity reference standards are highly characterized chemical substances used as benchmarks to identify, quantify, and qualify impurities in pharmaceutical drug substances and products. They are essential for pharmaceutical registration dossiers, method validation, and quality control.
Every product comes with a comprehensive COA including HPLC purity, H-NMR, C-NMR, MS, UV, and IR spectra — meeting ICH guidelines and accepted by NMPA, FDA, and EMA for pharmaceutical registration.
Yes. Our in-house R&D laboratory provides custom synthesis of novel impurity reference standards with full structural characterization and COA documentation. Contact us for a quote.
Trusted expertise in impurity reference standards since our founding
Self-owned laboratory with advanced HPLC, NMR, and MS equipment. Every product is characterized by our expert researchers.
Full COA with HPLC, NMR, MS, UV, IR data. Documentation meets ICH guidelines and is accepted by NMPA, FDA, and EMA.
Trusted by over 500 pharmaceutical companies worldwide for drug registration, method validation, and quality control.
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