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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

LATEST AROUND THE INDUSTRY

Extending Beyond Use Dating

Extending Beyond Use Dates for Compounded Preparations
Dr. Qiang Liu, Research and Development Laboratory Supervisor

A beyond use date (BUD) is the date after which a compounded preparation shall not be used. The BUD is determined from the date the preparation is compounded. This date should be based on drug-specific, scientifically valid studies when possible. Things to consider when assigning BUD include: 

  • The drug and its degradation mechanism
  • The dosage form and its components
  • The potential for microbial proliferation
  • The container in which the preparation is packaged
  • The expected storage conditions
  • The intended duration of therapy

USP <797> describes four methods for assigning a beyond use date:

  • Product labeling
  • Commercial product manufacturer consultation
  • Appropriate literature
  • Direct testing

Beyond use dating must be carefully interpreted with respect to the actual compounded formulation and conditions for storage and use. Predictions based on literature are considered theoretical beyond-use dates as the published data introduces varying degrees of assumptions with a likelihood of error or inaccuracy. Pharmacists using literature to assign a beyond use date must look for the exact drug formula, storage conditions, and container/closure to reduce the likelihood of errors. State and federal regulations also require pharmacists to have written justification for a beyond use date assignment.

The only truly valid beyond use date is obtained through product-specific studies supported by scientific data. These direct testing studies use stability indicating methods (SIM) to ensure therapeutic effectiveness of compounded drug products.  

A SIM is a reliable, meaningful, and specific analytical procedure that accurately and precisely measures active pharmaceutical ingredients (API) by separating the API from its degradation products and excipients.  A SIM must be validated for the exact formulation being tested.  High performance liquid chromatograph (HPLC) is one of the most commonly used techniques for examining the chemical stability of compounded product, but not all HPLC tests are stability indicating. A forced degradation study must be performed on the compounded drug product and not inferred from testing on only the API.

Testing the concentration of the drug is just one component of a stability study. Testing should include evaluation of the physical, chemical, and microbiological properties of the product. Common tests in a stability study include:

  • Assay (Stability Indicating Method)
  • Sterility – USP <71> (sterile preparations)
  • Endotoxin – USP <85> (sterile preparations)
  • pH – USP <791>
  • Visual Inspection   (Appearance)
  • Particulate Matter – USP <788> / <789> (all sterile solutions for IV injection or ophthalmic)
  • Preservative Effectiveness – USP <51> (preparations containing an antimicrobial preservative)
  • Preservative Quantification – (preparations containing an antimicrobial preservative)
  • Microbial Limits – USP <61> (nonsterile preparations)
  • Absence of Specified Organisms – USP <62> (nonsterile preparations)

Additional tests for biological products BUD include:

  • Protein content – USP <1057>
  • Potency or activity – such ELISA assay
  • Product related impurity including protein aggregates, size and charge variants

Please contact ARL (800) 393-1595 or info@arlok.com with questions.

ARL April News

ARL BioPharma April Newsletter

·         Potency  Testing

·         Q&A with Dr. Kupiec

·         Have you celebrated 20 years with 20% off?