Product Overview

4,6-Ethylidene-p-nitrophenyl-α-D-maltoheptaoside (EPS, CAS: 96597-16-9) is recommended by IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) as the preferred substrate for α-amylase (AMY) assays, and is a core raw material for the clinical diagnosis of digestive system diseases such as acute pancreatitis. Adopting an innovative chemoenzymatic synthesis route, we apply cyclodextrin hydrolase-based transglycosylation technology, directed evolution and AI-assisted design. The content of isomers is reduced from 40% to less than 1%, and the production yield is significantly improved. With excellent water solubility, superior storage stability and open-bottle stability, this product is fully compatible with mainstream fully automated clinical chemistry analyzers. It is widely used for the quantitative detection of α-amylase activity in serum and urine, R&D of in vitro diagnostic reagents, enzymology research and large-scale industrial production. Patent applications for our proprietary synthesis technology have been filed in China and under the PCT.

Key Features

High Purity & Low Impurities

HPLC purity ≥91%. Trace impurities such as pNPG7 and pNP are strictly controlled, significantly reducing background interference and ensuring accurate test results.

Wide Assay System Compatibility & Seamless Replacement

Fully compatible with mainstream domestic and international assay systems. Clinical sample test results show high consistency with imported products, with an average relative deviation of less than 2.5%, enabling direct replacement.

Excellent Thermal & Open-Bottle Stability

After 15 days of accelerated storage at 37°C, the relative deviation of test results is less than 2%. After 25 days of open-bottle storage, the relative deviation is less than 3.5%, making it suitable for long-term storage and on-board use of reagents.

Excellent Batch-to-Batch Consistency & Reliable Production Capacity

Mature large-scale production technology ensures stable quality. The average relative deviation between batches is no more than 5.0%. High single-batch output guarantees a stable supply for mass production.

Patent-Pending Innovative Technology

Our unique enzymatic synthesis route solves the global challenge of precise maltodextrin synthesis. Patent applications in China and under the PCT are pending, providing strong technical advantages.

Applications

Clinical Diagnostic Reagents

As the core substrate for α-amylase (AMY) assays based on IFCC standard methods, it is used for quantitative detection of amylase activity in serum and urine samples to aid in the screening and diagnosis of acute pancreatitis, mumps and other digestive system diseases. Compatible with all types of fully automated clinical chemistry analyzers.

Diagnostic Reagent R&D & Formulation Optimization

Superior water solubility and stability extend the shelf life and in-use stability of kits, supporting formulation iteration and performance upgrading for diagnostic reagent manufacturers.

Basic Enzymatic Research

Used as a standard substrate for activity measurement, kinetic analysis and inhibitor screening of α-amylase and α-glucosidase.

Industrial Production

Supply high-stability, batch-to-batch consistent raw materials for IVD enterprises, supporting standardized mass production and quality control of amylase assay kits.

Specification

Performance Data

Advantage 1: High Purity & Low Impurity

Reducing the Difficulty of Reagent Development and Replacement

Advantage 2: High Assay System Compatibility

Enabling Seamless Replacement for Customers.

Advantage 3: Percentage of relative values measured in clinical samples

Advantage 4: Strict Quality Control & Scalable Production, Dual Assurance to Reduce Batch-to-Batch Variation

Clinical samples covering the linear range were used to compare three lots of reagents, with an average relative deviation of no more than 5.0%.