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

Microbial Tests

USP <795> states that pharmacists performing non-sterile compounding must ensure that the finished preparation has its accepted potency, purity, quality, and characteristics.  This article discusses the tests described in USP <61> and USP <62> that are used to determine if non-sterile products meet quality requirements.  These tests can also be used by sterile compounders for qualifying raw materials and performing in-process quality control testing.  

T3/T4 Formulations

Liothyronine Sodium (T3) and Levothyroxine Sodium (T4) are iodonated amino acids and are typically formulated in microgram concentrations. These active pharmaceutical ingredients (APIs) contain water: up to 4% in the T3 powder and up to 11% in the T4 powder. The primary reasons for the difficulty in preparing formulations containing T3 and/or T4 arise from these 3 issues: microgram concentrations, iodination of the compound, and water.