Experience & Excellence
WELCOME TO ARL BIO PHARMA
Industries
Pharmacy
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.
Services Offered:
- Potency Determination
- BUD and Stability Studies
- Sterility
- Endotoxin
- Fungal
- Microbial Identification
- Microbial Enumeration Tests
- Tests for Specified Organisms
- Antimicrobial Effectiveness Testing
- Particulate Matter by Light Obscuration
- Particulate Matter by Microscopy
Raw Material
ARL Bio Pharma qualifies drug substances, excipients, and drug products to meet pharmacopeia specifications.
Services Offered:
- 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
- pH
- Viscosity
- USP / NF (United States Pharmacopeia) testing
- EP (European Pharmacopeia) testing
- JP (Japanese Pharmacopeia) testing
Pharmaceuticals
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.
Services Offered:
- Stability Studies
- Compatibility Studies
- Raw Material Testing
- Dissolution Testing
- Microbial Identification
- Bioequivalence Studies
- Pre-clinical and Clinical Analytical Testing
Forensics
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.
Services Offered:
- Chemical Analysis
- Biological Analysis
- Drug Diversion Testing
- Complaint Sample Testing
- Product Contamination
- Litigation Support
- Patent Infringement
- Literature Research and Review
Industrial Hemp and CBD
ARL Bio Pharma tests industrial hemp and cannabidiol (CBD) to meet industry quality specifications.
- Potency Testing
- Pesticides
- Heavy Metals
- Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms <62>
- Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests USP <61>
- Stability Studies
LATEST AROUND THE INDUSTRY
USP 800 Surface Wipe Sampling
According to Center for Disease Control and Prevention (CDC), over 8 million US healthcare workers are exposed to hazardous drugs (HDs) every year. Drugs classified as hazardous include cancer therapy, antiviral drugs, hormones, and bioengineered drugs.
More than 12 billion doses of HDs are handled by US providers each year. Anyone handling HDs is at risk of exposure to acute and long-term effects including hair loss, cardiac toxicity, kidney damage, hearing loss, nausea, rashes, cancer, and infertility.
Data Integrity
According to the FDA, ensuring data integrity is an important component of industry's responsibility to ensure the safety, efficacy, and quality of drugs. ARL Bio Pharma has GMP software that controls our laboratory's instruments and generated data. This software complies with 21CFR Part 11 as it relates to electronic records. All data is locked down and backed up so ARL can retrieve information in its native format with tracked changes and modifications. Our validated software meets FDA's expectation for GMP Compliance to provide our clients with data integrity critical to the GMP data lifecycles.
To learn more about Data Integrity and Compliance with Drug cGMP, click here.