Front Range Labs

We are a full-service independent laboratory that has been a trusted partner of the compounding pharmacy community for more than 25 years. With a lab staffed by scientists and industry experts, Front Range Labs is well-equipped to serve all compounding pharmacies... 503A OR 503B.

SERVICES

Sterility

Our sterility testing methods will evaluate your compounded sterile products for the presence of viable bacteria as required by USP<797>.

USP<71> is our road map for analysis. Your products are tested within an ISO 5 environment by aseptically trained technicians.

Based on your testing requirements, we can peform and provide a Certificate of Method Suitability according to USP<71>for your formulation.

Bacterial Endotoxins

We offer bacterial endotoxin testing methods to screen your compounded products for the presence of pyrogen as required by USP<797>.

Our Microbiology Department is able to complete bacterial endotoxin analysis within a 24 hour period. We are able to help you determine the Minimum Valid Concentration, Maximum Valid Dilution and the Endotoxin Release Limit for your specific product.

Based on your testing requirements, we can perfom and provide a Certificate of Verification according to USP<85> for your formulation.

Potency

Knowing the correct concentration of your active ingredient within a compounded product is an important component in the quality control process for any compounding pharmacy. In fact, it is required per USP<795> and <797>.

Our chemistry department uses USP-Verified Methods, USP<1226>, or In-house Validated Methods, USP<1225>, to ensure your products are tested correctly. In every test possible we use USP-sourced reference standards.

The following is just an example of the additional comprehensive testing we can provide:

Stability Studies
API Testing
Bulk and In-process analysis
Chemical Identification
Preservative Effectiveness and Efficacy
Dissolution
Method Development
Bioburden/Total Plate Count
Growth Promotion