ARL Bio Pharma provides analytical and microbiological testing for California compounding pharmacies, outsourcing facilities, and health-system pharmacies. Our laboratory partners with California Pharmacy Association so pharmacies can meet state quality requirements and release safe, effective drug products easier and faster.
CPhA members also receive a 10% discount on testing services.
Submit Samples for testing through ARL's Client Portal. Make sure to write "CPhA Member" on required new client forms to receive 10% discount.
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
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).
The container closure system for a drug product provides critical protection for stability and sterility. ARL offers USP <1207> container closure integrity testing (CCIT) on IV bags, syringes, cassettes, and vials. Three types of leaks that can be detected during CCIT include:
- Entry of microorganisms
- Escape of the product dosage form or entry of liquids or solids
- Escape of nitrogen gas or entry of oxygen, water vapor, or air gases
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.
An endotoxin test detects toxins that are released from the cell wall of disrupted gram-negative bacteria.
This test identifies microorganisms isolated during different phases of manufacturing 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.
These tests quantitate the total population of aerobic bacteria and yeast and molds in raw materials, in-process samples, finished products.
These tests verify the absence of objectionable microorganisms in drug products and raw materials.
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.