Experience & Excellence
WELCOME TO ARL BIO PHARMA
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.
- Potency Determination
- BUD and Stability Studies
- Microbial Identification
- Microbial Enumeration Tests
- Tests for Specified Organisms
- Antimicrobial Effectiveness Testing
- Particulate Matter by Light Obscuration
- Particulate Matter by Microscopy
ARL Bio Pharma qualifies drug substances, excipients, and drug products to meet pharmacopeia specifications.
- Identification by IR
- Identification by UV
- Specific Gravity
- Water – Methods 1a, 1b, 2 and 3
- Residual Solvents
- Melting Point / Melting Range
- Loss on Drying
- Residue on Ignition
- Assay – HPLC, UV, Titration
- Heavy Metals
- USP / NF (United States Pharmacopeia) testing
- EP (European Pharmacopeia) testing
- JP (Japanese Pharmacopeia) testing
ARL provides full laboratory services for pharmaceutical and biotechnology companies. Laboratory services include testing for New Drug Application (NDA), Abbreviated New Drug Application (ANDA), medical devices (510K) and over-the-counter products.
- Stability Studies
- Compatibility Studies
- Raw Material Testing
- Dissolution Testing
- Microbial Identification
- Bioequivalence Studies
- Pre-clinical and Clinical Analytical Testing
ARL Bio Pharma provides comprehensive services to solve challenging drug investigations. These services are unique and specialized in pharmaceutical, toxicological, regulatory support, and research and development.
- Chemical Analysis
- Biological Analysis
- Drug Diversion Testing
- Complaint Sample Testing
- Product Contamination
- Litigation Support
- Patent Infringement
- Literature Research and Review
LATEST AROUND THE INDUSTRY
The Importance of Testing Bulk Substances
A bulk substance, also known as an active pharmaceutical ingredient (API), is often the starting point of a compounded preparation. Prior to use, compounding pharmacies and outsourcing facilities should confirm the quality of an active pharmaceutical ingredient to ensure consistency of the material as received from the supplier and suitability for use in a compounded preparation. At a minimum, identity testing is recommended for each lot, but more rigorous testing should be evaluated.
Method Suitability and its Importance...
Sterility testing by USP <71> is a test used in tandem with other sterility assurance procedures and tests to ensure that a product is free of microbial contaminants and safe for patients to use. For a sterility test to perform appropriately, a method suitability validation must be completed on each specific formulation to determine the appropriate test method.