ARL Bio Pharma provides analytical and microbiological testing for health-system pharmacies. Our laboratory makes the test process simple so you can meet industry quality requirements and release safe, effective drug products easier and faster.
Submit Samples for testing through ARL's Client Portal.
This test measures the concentration of the active ingredient at a specific point in time.
- Potency Price List
- Benefits of Submitting Master Formulation Records
- Potency Test Failure Case Studies
- Drug Formulation and Its Impact on Analytical Testing
- Stability vs. Potency Testing
- Potency Testing Benefits and Requirements
- Importance of Sample Amounts and the Impact on Potency Testing
- Validated Potency Methods – NonGMP
ARL provides nonGMP and GMP testing. Click here to request a quote for GMP Potency testing.
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).
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.
A rapid sterility test detects microbial contamination. This validated alternative sterility test method per USP <1223> is effective and reliable for health-system pharmacies. Rapid test provides objective results in as little as six days.
An endotoxin test detects toxins that are released from the cell wall of disrupted gram-negative bacteria.
This test identifies microorganisms isolated during environmental monitoring and quality testing to the genus/species level using DNA sequencing.
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.
A particulate matter tests for the presence of extraneous substances including: dust, glass, drug precipitates, rubber and other insoluble materials.
Microbial cleaning studies are essential to validating a facility’s cleaning SOP. Pharmacies must demonstrate that cleaning agents, combined with instructions and procedures for their use, remove microbial contamination from surface areas where sterile drug products are compounded.
This test measures the level of hazardous drug surface residue to verify workplace safety.
Drug Diversion is the transfer of licit drugs for illicit purposes. ARL Bio Pharma's investigative services can provide additional evidence of drug diversion. Testing services include: drug identity confirmation, unknown drug identification and drug concentration analysis.