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 <85> Bacterial Endotoxin Validation
ARL Bio Pharma utilizes the kinetic turbidimetric method described in USP <85> Bacterial Endotoxins Test to provide results. An endotoxin test detects toxins that are released from the cell wall of disrupted gram-negative bacteria. This is a reaction over time test that quantitates the amount of endotoxin in a sample compared to a standard curve. This article discusses USP <85> challenges and why method validation is important to provide consistent results.
The most common challenge encountered while performing endotoxin testing is that many drug products cause the assay reaction to slow down (inhibition) or speed up (enhancement) during the testing process, which does not allow for an accurate result to be obtained. Those properties which cause the inhibition or enhancement must be overcome to obtain a reliable and repeatable test result. Microbiologists performing testing must determine the degree in which inhibition or enhancement is occurring. This is done by adding known amounts of endotoxin to test samples and comparing the results to those known values. If there is no inhibition or enhancement, results from the test samples spiked with a known amount of endotoxin will be the same as the expected results. Inhibition would artificially lower results for the test sample, and enhancement would increase results for the test sample, relative to the expected spike concentration.
Once inhibition or enhancement is understood, microbiologists can develop a plan of action to overcome those sample properties.
Growth Promotion Testing
Growth Promotion demonstrates that media used in environmental monitoring programs, media fills, or personnel qualification are capable of supporting microorganism growth.
Benefits of growth promotion testing:
- Reduces risk of false negative results if media does not support growth
- Reduces risk of false positive results if media is contaminated (negative control sample required)
- Ensures media used in environmental monitoring provides an accurate representation of environmental control in compounding areas
- Meets FDA and USP microbiological growth media requirements
- Verifies media vendor's certificate of analysis
ARL has a new submission form specific for "Growth Promotion" tests. This new form is a quick selection form for media types, organism tests, and incubation time and temperature.