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
Prevent Future Sterility...
Prevent Future Sterility Failures by Identifying Contaminating Microorganisms
James Zellner, Technical Sales
Identification of a contaminant in a sterile preparation is vital to determining the origin of the microorganism and its avenue of entry. The organism’s identity, combined with environmental monitoring data, provides actionable information to improve a pharmacy’s processes and prevent future contamination.
Potency Test Failure...
Common compounding problems causing a sample to fail: case studies
Berenice Dethier, Research Chemist II
A potency test measures the amount of API in a formulation to ensure the product is within its specifications. Criteria for acceptance are set by the client and/or follow the industry benchmarks (generally set by USP).
Several factors can contribute to a failing potency result. Investigating the root cause of the failing potency test is an important practice to characterize the true cause(s) of the failure. The goal of the out of specification (OOS) investigation is to identify what, how, and why the failure occurred. To answer all three questions, OOS investigations should include a comprehensive review of all aspects of the formulation procedure. The review typically includes everything between the acceptability of the raw materials to the validity of the potency test result. Understanding the factors that contributed to the potency failure allows the pharmacist a more strategic approach in eliminating future failures. The more specific the findings into the failure, the easier it is to properly address.