Enzyme reagent

for food safetyfor microbiologyfor the pharmaceutical industry

Product Introduction
Enzyme treatment provides a controlled solution for microbial limit testing of potent antibiotics by specifically inactivating antibiotic activity that interferes with microbiological assays. These reagents include β-lactamases and other antibiotic‑inactivating enzymes produced by biological systems; they catalyse the breakdown or inactivation of target antibiotic classes to enable reliable sterility and microbial limit testing of samples containing antibiotics.

How to use

• Liquid: Each vial is used directly for sterility testing without reconstitution.
• Lyophilized powder: Dissolve each vial in 5 ml of sterile water before use for sterility testing.
• Storage: Refrigerate at 2–8 °C.
• Packaging: 10 vials per box.

Available enzyme products

• Penicillinase
• Cephalosporinase
• Metallo-β-lactamase
• Cefixime-specific enzyme
• Glycopeptidase
• Vancomycinase
• Macrocyclic lactonase
• Polymyxinase
• Aztreonamase
• Doxycyclinease
• Clindamycinase
• Rifamycinase
• Gentamicin sulfate-specific enzyme
• Others (each enzyme has distinct properties)

Features
β-lactamase and related enzyme reagents enable faster and specific inactivation of β-lactam antibiotics, improving the accuracy and turnaround time of sterility and microbial limit tests. Products are supplied in liquid and lyophilized forms to suit laboratory workflows and validation requirements.

Intended use / Applications
Used for sterility testing of β-lactam antibiotic raw materials and injectable drug products, and for microbial limit testing of oral and other β-lactam antibiotics. Applicable sectors include:

• Pharmaceutical manufacturing
• Food & Beverage testing
• Biotechnology laboratories

Specifications / Technical details

• Product type: Enzyme reagents for sterility test and microbial limit test (β-lactamase and other specific antibiotic-inactivating enzymes)
• Forms available: Liquid and lyophilized powder
• Lyophilized reconstitution: Dissolve each vial in 5 ml sterile water
• Usage: Liquid vials used directly; lyophilized vials require reconstitution
• Storage conditions: 2–8 °C (refrigerated)
• Packaging: 10 vials per box
• Regulatory note: According to the Chinese Pharmacopoeia, β-lactam antibiotics can be inactivated by β-lactamases
• Primary applications: Sterility testing of β-lactam antibiotic raw materials and injectable drugs; microbial limit testing of oral and other β-lactam antibiotics