ARL Bio Pharma provides analytical and microbiological testing for compounding pharmacies, outsourcing facilities, and health-system pharmacies. Our laboratory partners with industry suppliers bringing excellence to the compounding industry.
This test measures the concentration of the active ingredient at a specific point in time.
A stability study measures the extent to which a product retains, within specified limits, and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of compounding.
A study commonly includes: a stability indicating method assay, sterility (for sterile preparations), endotoxin (for most sterile preparations), pH, visual inspection, particulate matter, preservative effectiveness, preservative quantification, microbial limits (for non-sterile preparations), and the absence of specified organisms (for non-sterile preparations).
Sterility USP <71>
A sterility test detects microbial contamination. A satisfactory result indicates that no contaminating microorganism has been found in the sample examined under the conditions of the test.
Endotoxin USP <85>
An endotoxin test detects toxins that are released from the cell wall of disrupted gram-negative bacteria.
This test is designed to increase the likelihood of detecting fungal microorganisms in sterile products.
This test identifies microorganisms isolated during different phases of manufacturing and quality testing to the genus/species level using DNA sequencing.
Antimicrobial Effectiveness Testing USP <51>
An antimicrobial effectiveness test demonstrates the effectiveness of antimicrobial preservatives in preventing microbial proliferation in injections, topicals, oral products, single dose vials, and antacids packaged in multiple-dose containers.
Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests USP <61>
These tests quantitate the total population of aerobic bacteria and yeast and molds in raw materials, in-process samples, finished products.
Microbiological Examination of Nonsterile Products: Tests for Specified Organisms USP <62>
These tests verify the absence of objectionable microorganisms in drug products and raw materials.
Particulate Matter USP <788>/<789>
A particulate matter tests for the presence of extraneous substances including: dust, glass, drug precipitates, rubber and other insoluble materials.
All services provided will adhere to ARL Bio Pharma’s terms and conditions