LeadGMP® PNGase F

Expression System

Escherichia coli

Concentration

400 U /μL

Storage Buffer

20mM Tris-HCl, 50mM NaCl, 5mM EDTA, pH 7.5

Purity

>95% as determined by SDS-PAGE analysis.

Unit Definition

One unit is defined as the amount of enzyme required to remove > 95% of the carbohydrate from 10 µg of denatured RNase B in 1 hour at 37°C in a total reaction volume of 10 µl.

Endotoxin Level

<0.05 EU per 1 µg of the protein by the LAL method.

Mycoplasma

Not detected

Form

Liquid

Stability & Storage

This product is stable after storage at:

• -20°C for long-term storage under sterile conditions. Avoid repeated free-thaw cycles.

Manufacturing Specifications

LeadGMP® recombinant proteins are manufactured in ISO 13485:2016 and GMP certified facility. The processes include:

• Animal-free reagent and laboratory
• Manufactured and tested under GMP guideline
• Testing and traceability of raw material
• Records of the maintenance and equipment calibration
• Personnel training records
• Batch-to-batch consistency
• Documentation of QA control and process changes
• Manufactured and tested under an ISO 13485:2016 certified quality management system
• Stability monitor of product shelf-life