World's First! NanoMicro Leads Release of International Standard for Silica Chromatography Resins

Great News!

The international standard led by NanoMicro ISO/TS 4966:2026 "Nanotechnology — Specifications and test methods for nanoporous silica microparticles for liquid chromatography" has been officially approved and published on the ISO website!

The standard was successfully completed under the guidance of the Materials Specifications Working Group (ISO/TC229/WG4) of the ISO Nanotechnology Committee, whose secretariat is hosted by the National Center for Nanoscience and Technology of China.

Screenshot from the ISO official website

The development of this standard took nearly 8 years from preparation to official release, spanning multiple rounds of cross-border negotiations and technical validation. This is the world's first ISO international standard in the liquid chromatography silica resin segment, marking that Chinese chromatography resin manufacturers have taken center stage in international standardization, establishing a unified quality control benchmark for the global liquid chromatography resin industry!

November 2025

Chinese delegation at the ISO TC229 Incheon meeting, South Korea

May 2026

Discussion session on silica for liquid chromatography at the ISO TC229 Sydney meeting, Australia

NANOMICRO

Value of the Standard

Ending the absence of a unified international standard

Before this standard, the global liquid chromatography silica resin industry faced long-standing challenges: inconsistent definitions of performance indicators across manufacturers, varying test methods, and difficulties in cross-border product quality benchmarking. Downstream pharmaceutical and testing laboratories lacked authoritative references for raw material selection and cross-border compliant procurement.

ISO/TS 4966:2026 clearly specifies the core indicators and standardized measurement methods for powder-form nanoporous silica chromatography resins (without post-surface modification), covering key quality control dimensions such as particle size, pore size, and specific surface area. It also clearly defines the applicable boundaries, with rigorous rules and strong guidance.

NANOMICRO

NanoMicro's Leadership

Leading international rule-making with core technology

As a leading enterprise in monodisperse microsphere chromatography resins in China, NanoMicro has been deeply engaged in silica-based chromatography resins for over a decade, with independently controlled core technologies for the preparation of monodisperse porous silica microspheres. Our products are widely used in key fields such as biopharmaceutical purification, food safety testing, environmental analysis, and clinical diagnostics, and are exported in bulk to dozens of countries including Europe, the US, Japan, and South Korea. We empower product iteration with standards and drive industrial upgrading with technology, helping China's high-end biopharmaceutical separation consumables industry go global with high quality!

Leading this international standard is no coincidence:

Deep technical expertise: Leveraging years of mass production experience, we have developed an indicator system that aligns with industrial production and downstream practical applications, avoiding the pitfalls of purely laboratory-based standards detached from industry;

Broad industry vision: We connected with upstream and downstream experts across the global industry chain, balancing production and regulatory practices across Europe, the Americas, and the Asia-Pacific region;

Breakthrough as a national champion: We broke the pattern where European and American companies dominated international standards in the chromatography field, with a Chinese enterprise now defining the quality evaluation logic for resins.

NANOMICRO

NanoMicro's Strength

Empowering biopharmaceuticals with underlying innovation

In the world of anti-diabetic drugs, GLP-1 medications are undoubtedly the "top players." Starting from glucose control, they continue to expand their boundaries with outstanding performance, now making waves in weight management, cardiovascular, and metabolic diseases, becoming one of the most explosive tracks in the pharmaceutical industry.

NanoMicro's UniSil Revo series silica resins deliver exceptional performance. Featuring our proprietary PCS precise pore control technology, these resins enhance interconnectivity between pores and thicken pore walls, significantly improving mechanical strength and separation selectivity. The unique organic hybrid surface treatment and bonding technology also provide a wider pH tolerance range. These characteristics make them particularly suitable for purifying larger peptides, especially GLP-1 and insulin.

UniSil Revo 10-100 C8

Tirzepatide Purification Case Study

Figure 1-1. First-step purification chromatogram of tirzepatide using UniSil Revo 10-100 C8

Figure 1-2. Second-step purification chromatogram of tirzepatide using UniSil Revo 10-100 C8

Figure 1-3. Third-step purification chromatogram of tirzepatide using UniSil Revo 10-100 C8

Figure 2. Analytical chromatogram comparison before and after purification using UniSil Revo 10-100 C8

To address the challenges of tirzepatide separation and purification, NanoMicro has developed a three-step reversed-phase silica purification process based on UniSil Revo 10-100 C8 resin, combined with our peptide process development expertise. This process features high loading capacity and high purity. Results show that after three purification steps, crude purity can be increased from 67.3% to 99.6%, with single impurities<0.1%, meeting product quality control requirements, and demonstrating good lifetime performance in large-scale production.

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The continuous expansion of the global diabetes and obesity population has fueled the hundred-billion-dollar GLP-1 market. Tirzepatide, with its dual-target advantage, is reshaping the metabolic disease treatment landscape. High purity is the key prerequisite for tirzepatide to deliver efficacy and capture market share. NanoMicro's UniSil Revo series chromatography resins provide a precise solution, offering core support for the commercial success of tirzepatide. As GLP-1 competition intensifies, NanoMicro will continue to empower innovative drug development with robust purification technology, helping companies seize the metabolic disease treatment track and unlock the full potential of this hundred-billion-dollar market.

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World's First! NanoMicro Leads Release of International Standard for Silica Chromatography Resins

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