Quality Service through

Experience & Excellence

WELCOME TO ARL BIO PHARMA

ARL Bio Pharma provides analytical and microbiological testing for the pharmaceutical industry. Our laboratory works with pharmaceutical companies, compounding and hospital pharmacies, drug manufacturers, and raw material suppliers bringing excellence to pharmaceutical sciences.

Industries

Pharmacy

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

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

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

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
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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

Particulate Matter Testing

What is particulate matter and why is testing performed?

Particulate matter is unwanted solid material in solutions for injection. Particle counts that exceed USP limits in intravenous drug products could block blood flow inside the patient's body causing paralysis or death.  

 

Particulate matter testing is a good indicator of the quality of a manufacturing process and the containers used. 

OOS Investigation Part 2

ARL’s out-of-specification investigations use a hybrid approach to review data, formulations, and tests. Our data reviewers consult with ARL’s scientific directors and clients to ensure we provide a 360-view investigation and evaluate all aspects of the laboratory, data, and client and analyst trends. Typical investigations are concluded within one week or within 4 business days after the due date.