Table of contents
Introduction
The recent official release of the 2025 edition of the Chinese Pharmacopoeia formally included a number of analytical columns from Welch Materials, covering both traditional Chinese medicines and chemical drugs. These inclusions have drawn significant attention across the industry.
The new edition introduces higher standards for pharmaceutical analysis. Whether it's the complex fingerprint analysis of traditional Chinese medicines or the demanding detection of related substances in chemical drugs, Welch columns meet the stringent requirements of the Pharmacopoeia, helping users comply rigorously with regulatory standards and safeguard drug quality and safety.
Thanks to their outstanding stability and wide applicability, Welch columns offer precise and efficient separation solutions for pharmaceutical companies and testing institutions.
In the 2025 edition, Welch columns are recommended in 4 monographs under Volume I and 9 monographs under Volume II. This article summarizes their applications and technical highlights, serving as a reference for analysts worldwide.
Ultisil XB-C18
Applications:
Monograph | Sample | Application | Product |
Volume I |
Belladonna Fluid Extract Belladonna Extract Belladonna Tablet Belladonna Tincture |
Fingerprint analysis Scopoletin |
Ultisil XB-C18 |
Volume II |
Zolmitriptan Zolmitriptan Tablet Zolmitriptan Orodispersible Tablet |
Related substances |
Technical Highlights:
- Incorporates novel bonding and double end-capping technologies to deliver nearly perfect peak shapes.
- Offers high theoretical plate numbers and peak capacity.
- Exceptional separation performance makes it one of the most versatile C18 columns on the market.
Ultisil LP-C18
Applications:
Monograph | Sample | Application | Product |
Volume II | Amphotericin B | Related substances | Ultisil LP-C18 |
Technical Highlights:
- Designed for use under high temperature and low pH conditions (as low as pH 0.5), offering exceptional column lifetime and reproducibility.
- No end-capping: avoids selectivity changes caused by hydrolysis of end-capping agents in acidic environments, ensuring long-term selectivity and reproducibility under low pH.
- Delivers superior peak shapes under low pH conditions, with a selectivity distinct from XB-C18.
- Strong polarity and high surface area: due to the absence of end-capping, LP-C18 is more polar than AQ columns and ideal for retaining and separating polar compounds with excellent peak shape.
- Fully compatible with 100% aqueous mobile phases—functions as an AQ column with better peak shape and resolution.
- Optional 300 Å pore size version available upon request, suitable for separating peptides and proteins under acidic conditions.
Xtimate C18
Applications:
Monograph | Sample | Application | Product |
Volume II |
Bivalirudin Bivalirudin for Injection |
Related substances I Determination of content |
Xtimate C18 |
Technical Highlights:
- Employs Welch’s proprietary organic–inorganic hybrid bonding technology. The silica matrix core retains high mechanical strength and separation efficiency, while the surface is grafted with a highly pH-stable organic hybrid layer. Thus extends pH stability range to 1–12.5.
- Offers consistent performance and long column lifetime even under extreme conditions, significantly outlasting conventional C18 columns under normal use.
Ultisil Diol
Applications:
Monograph | Sample | Application | Product |
Volume II | Propofol Emulsion for Injection |
Lysophosphatidylcholine Lysophosphatidylethanolamine |
Ultisil Diol |
Technical Highlights:
- Compared to bare silica or amino columns, Ultisil Diol is a much more stable and reproducible normal-phase column.
- Enhanced selectivity and peak shape for certain compounds, based on modified pure silica.
- High column efficiency and extended operational lifetime.
Ultisil XB-NH₂
Applications:
Monograph | Sample | Application | Product |
Volume II | Acarbose | Related substances | Ultisil XB-NH₂ |
Technical Highlights:
- Under reversed-phase conditions, ideal for separating various monosaccharides (yet not suitable for compounds containing aldehyde or carbonyl groups).
- Under normal-phase elution, suitable for polar compounds, tocopherols, and other organics soluble in alkanes, hydrocarbons, and aromatics.
- In low-pH buffer systems, functions as a weak anion exchanger, capable of separating negatively charged molecules and underivatized amino acids.
Ultisil Amy-D
Applications:
Monograph | Sample | Application | Product |
Volume II | Atorvastatin Calcium | Enantiomer | Ultisil Amy-D |
Technical Highlights:
- The Ultisil Amy-D chiral stationary phase consists of spherical silica gel coated with linear amylose derivatives.
- One of the most broadly applicable chiral columns, suitable for compounds with chiral centers such as aromatic, nitro, carbonyl, amide, amino, carboxyl, cyano, hydroxyl, and sulfonyl groups, as well as bulky molecules with asymmetric steric hindrance.
Conclusion
Welch Materials remains committed to delivering premium products and services to our customers. The exceptional performance of Welch HPLC columns in the 2025 edition of the Chinese Pharmacopoeia stands as a testament to our continued innovation and dedication.
We extend our sincere gratitude to every customer for your trust and support—your confidence drives our progress.
Looking ahead, Welch Materials will uphold our principles of professionalism, innovation, and focus, and continue to develop advanced chromatographic solutions. We aim to provide more efficient and precise products for pharmaceutical analysis, life sciences, and beyond.
If you have any questions or specific requirements regarding column usage, we welcome you to contact our team at any time. The experts at Welch Materials are ready to support you as we shape a better future together.