CPC Macroduster™ unique solution for inactivating macrolide antibiotics

As a CDMO that specializes in the supply of enzymes for Quality Control (QC) and antibiotics inactivation, CPC Biotech has developed Macroduster^™ as a unique solution for inactivating macrolide antibiotics.

Macroduster^™ is the only product on the market capable of inactivating macrolides such as such as Azithromycin, Erythromycin, Clarithromycin and Roxithromycin.

Its design draws on CPC’s experience as a recognized world expert in antibiotic inactivation and a trusted consultant for several international pharmaceutical bodies.

Macroduster^™ applications

Macroduster^™ is a highly innovative enzymatic product that makes it possible to perform sterility tests, total count and environmental monitoring on macrolides.

Prime applications are for microbial enumeration tests such as total aerobic microbial count; (TAMC) and total yeast/ mold count (TYMC,) on non-sterile macrolids as well as for pathogen detection and in sterility testing for injectable macrolids.

Macroduster can also be used in agarized (solidified) media for environmental monitoring, as well as in media fill.

Macroduster^™ features

Macroduster respects and conform to the guidelines laid down under the EU Pharm and United States Pharmacopeia (USP) standards (i.e., USP <71> (sterility testing), USP <61> (Microbiological Examination Of Nonsterile Products: Microbial Enumeration Tests), and USP <1116> (Microbiological Control and Monitoring of Aseptic Processing Environments).

These indicate need to carry out microbiological tests (sterility, total count, environmental monitoring) on compounds with antimicrobial activity (such as macrolides) by adding inactivating agents of the same compounds.

Macroduster is free of any animal derivatives and is certified as a TSE/BSE free product, making it particularly suitable for media fills.

Macroduster^™ product range

Macroduster is currently available in a non-sterile freeze-dried (lyophilized) formulation, sold together with a buffer provided to accelerate dissolution of the powder.

Each pack consists of equal number of vials of macrolidase and vials of diluent solution. Each 1 IU of macrolidase is defined as the amount of enzyme needed to inactivate 1 μmol of Erythromycin at 25°C and pH 6.7.

Freeze dried Macroduster has a stability of three years from manufacturing date if stored at +2/8°C. After reconstitution with diluent solution and sterile filtration, the solution can be stored at least for three weeks at +2/8°C.

The Macroduster non-sterile lyophil product range currently comprises:

Resources

Click on Macroduster Product Sheet to download full specifications and usage guide.