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About LANING Biotechnology

Committed to excellence in pharmaceutical impurity reference standards since our founding

Dedicated to Reliable Impurity Reference Standards

Guangzhou Lanning Biotechnology Co., Ltd. is a technology-driven enterprise focused on the development of impurity reference standards involved in the pharmaceutical registration process. We provide custom synthesis, preparative separation, and comprehensive impurity research solutions for pharmaceutical registration.

With our own R&D laboratory and product quality inspection department, we ensure controllable quality. All products come with complete analytical documentation including COA, H-NMR, C-NMR, MS, HPLC, UV, and IR spectra. Our products are for research use only, and we are committed to helping reduce drug development costs and accelerate the R&D process.

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R&D Excellence

Self-owned R&D laboratory with advanced analytical equipment and experienced researchers.

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Quality Assurance

Complete COA and spectral data for every batch. ISO-certified quality management system.

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Customer-Centric

People-oriented and integrity-based. We build long-term partnerships with our clients.

7+
Product Categories
500+
Reference Standards
100+
Pharma Partners
24/7
Technical Support
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Technical Capabilities

πŸ§ͺ Custom Synthesis

Our in-house R&D team designs and synthesizes novel impurity reference standards from milligram to gram scale, with full structural confirmation.

πŸ“Š Analytical Characterization

Complete analytical documentation including COA, HPLC, H-NMR, C-NMR, MS, UV, and IR spectra β€” meeting ICH Q3 guidelines for pharmaceutical registration.

πŸ”¬ Preparative Separation

Isolation and purification of impurities from drug substances using preparative HPLC and other advanced separation techniques.

πŸ“¦ Global Logistics

Worldwide shipping via DHL, FedEx, and standard courier. Cold chain shipping available for temperature-sensitive reference standards.

How We Work

1

Inquiry

Tell us your impurity standard requirements or custom synthesis needs

2

Quotation

Receive a detailed quote with pricing, specifications, and delivery timeline

3

Production

Our R&D lab synthesizes, purifies, and characterizes your reference standards

4

Delivery

Receive your standards with complete COA documentation, shipped worldwide

Quality & Compliance

All impurity reference standards from LANING BIOTECHNOLOGY are produced in compliance with international pharmaceutical standards. Our documentation meets the requirements of major regulatory agencies worldwide.

ICH Q3 Guidelines NMPA Accepted FDA Compliant EMA Standards CTD Format