ARL Bio Pharma provides analytical and microbiological testing for health-system pharmacies. Our laboratory makes the test process simple so you can meet industry requirements and release quality drug products easier and faster.
Submit Samples for testing through ARL's Client Portal.
This test measures the concentration of the active ingredient at a specific point in time.
Articles:
- Benefits of Submitting Master Formulation Records
- Chemical Testing Aspects of USP 797 for Compounded Sterile Preparations
- Drug Formulation and Its Impact on Analytical Testing
- Importance of Sample Amounts and the Impact on Potency Testing
- Potency Test Failure Case Studies
- Potency Test System Suitability
- Potency Testing Benefits and Requirements
- Stability vs. Potency Testing
- T3/T4 Formulations
- Test Specifications
ARL provides nonGMP and GMP testing. Click here to request a quote for GMP Potency testing.
A stability study measures the extent to which a product retains, within specified limits, and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of compounding.
A study commonly includes: a stability indicating method assay, sterility (for sterile preparations), endotoxin (for most sterile preparations), pH, visual inspection, particulate matter, preservative effectiveness, preservative quantification, microbial limits (for non-sterile preparations), and the absence of specified organisms (for non-sterile preparations).
Articles:
- Chemical Stability of Admixtures Containing Ziconotide 25 mcg-mL and Morphine Sulfate 10 mg-mL or 20 mg-mL During Simulated Intrathecal Administration
- Compatibility and Stability of Palonosetron Hydrochloride and Propofol During Simulated Y-Site Administration
- Compatibility and Stability of Palonosetron Hydrochloride with Four Neuromuscular Blocking Agents During Simulated Y-Site Administration
- Compatibility and Stability of Palonosetron Hydrochloride with Gentamicin Metronidazole or Vancomycin During Simulated Y-Site Administration
- Compatibility of Caspofungin Acetate Injection with Other Drugs During Simulated Y-Site Coadministration
- Compatibility of Micafungin Injection with Other Drugs During Simulated YSite Coadministration
- Drug Compatibility with a New Generation of VISIV Polyolefin Infustion Solution Containers
- Extending Beyond Use Date for Compounded Preparations
- Importance of Forced Degradation in Stability Indicating Methods
- Palonosetron Hydrochloride Compatibility and Stability with Three Beta-Lactam Antibiotics During Simulated Y-Site Administration
- Pharmaceutical Compounding Errors
- Physical and Chemical Stability of Palonosetron Hydrochloride with Glycopyrrolate and Neostigmine During Simulated Y-Site Administration
- Physical and Chemical Stability of Palonosetron with Metoclopramide and Promethazine During Simulated Y-Site Administration
- Proactive Approaches to Mitigate Stability Failures
- Quality Control Analytical Methods-Stability Versus Potency Testing-The Madness is in the Method
- Stability of Metronidazole Benzoate in SyrSpend SF One-Step Suspension System
- Stability vs. Potency Testing
- What Factors Influence Stability?
Webinars:
- Beyond Use Date Strategies for Compounded Preparations
- Compounded Sterile Products: Extending Beyond Use Dating and Batch Release Testing for 503A and 503B Facilities
- Extending Beyond Use Dating for Compounded Preparations
- Root Causes of Stability Failures
- Stability Indicating Methods
- Stability Studies: Architecture Behind Establishing a Beyond Use Date
- Stability Testing: Science and Compliance
The container closure system for a drug product provides critical protection for stability and sterility. ARL offers USP <1207> container closure integrity testing (CCIT) on IV bags, syringes, cassettes, and vials. Three types of leaks that can be detected during CCIT include:
- Entry of microorganisms
- Escape of the product dosage form or entry of liquids or solids
- Escape of nitrogen gas or entry of oxygen, water vapor, or air gase
Articles:
- Container Closure Integrity Testing - vacuum decay test method
- Container Closure Integrity Testing - dye ingress test method
- Minor Chapters, Major Impacts – What USP Chapters 51, 61, 62, and 1207 Mean for Your Compounding Practice
Webinar:
A sterility test detects microbial contamination. A satisfactory result indicates that no contaminating microorganism has been found in the sample examined under the conditions of the test.
Articles:
- Applications and Sterility of Autologous Serum Eye Drops
- Basics of Sterility Testing
- Laboratory Considerations of USP Chapter 71 Sterile Tests
- Method Suitability and Its Importance to the Test Method
- Open vs Closed Membrane Filtration Systems
- Sterility Test Failure: Possible Causes and Investigation
- The Importance of Sterility Test Volume and Method Suitability Testing
- USP 71 Sterility Testing
Webinars:
A rapid sterility test detects microbial contamination. This validated alternative sterility test method per USP <1223> is effective and reliable for 503A and 503B Facilities.
ARL offers two alternative sterility test methods:
NEW – ScanRDI Solid Phase Cytometry Method: 0-2 Day Turnaround
This non-growth-based sterility test detects microbial contamination based on cytometry, which detects and quantifies microorganisms in as little as four hours. This ultra-rapid microbial detection method shortens investigation time by 1-2 weeks, leading to faster quality control improvements and process normalization. Speed up your distribution with ScanRDI and release drug products more quickly, lowering costs and reducing waste while eliminating bottlenecks.
Celsis ATP Bioluminescence Method: 6 Day Turnaround
This growth-based sterility test detects microbial contamination based on the presence of microbial Adenosine Triphosphate (ATP) in a sample. Results are objective and based on instrument analysis.
Articles:
- Dispense Drugs Faster with Rapid Sterility
- Rapid Sterility Testing
- Rapid Sterility Testing for Compounding Pharmacies
Webinars:
An endotoxin test detects toxins that are released from the cell wall of disrupted gram-negative bacteria.
Articles:
- Comparison of Endotoxin Testing Methods for Pharmaceutical Products
- Endotoxin Testing with a Contract Testing Laboratory
- Endotoxin Challenge Vials
- Endotoxin Essentials
- Endotoxin Limits
- The Importance of Endotoxin Testing
- USP <85> Bacterial Endotoxin Validation and Its Importance to the Test Method
Webinars:
This test identifies microorganisms isolated during different phases of manufacturing and quality testing to the genus/species level using DNA sequencing.
Articles:
An antimicrobial effectiveness test demonstrates the effectiveness of antimicrobial preservatives in preventing microbial proliferation in injections, topicals, oral products, single dose vials, and antacids packaged in multiple-dose containers.
Articles:
- Essentials of United States Pharmacopeia Chapter 51 Antimicrobial Effectiveness Testing
- Minor Chapters, Major Impacts – What USP Chapters 51, 61, 62, and 1207 Mean for Your Compounding Practice
- USP <51> Antimicrobial Effectiveness Testing
Webinars:
A particulate matter tests for the presence of extraneous substances including: dust, glass, drug precipitates, rubber and other insoluble materials.
Articles:
Microbial cleaning studies are essential to validating a facility’s cleaning SOP. Pharmacies must demonstrate that cleaning agents, combined with instructions and procedures for their use, remove microbial contamination from surface areas where sterile drug products are compounded.
Articles:
This test measures the level of hazardous drug surface residue to verify workplace safety.
Available Drugs:
- 5-Fluorouracil
- Chloramphenicol
- Cyclophosphamide
- Estriol
- Estradiol
- Estrone
- Finasteride
- Medroxyprogesterone Acetate
- Methotrexate
- Mitomycin
- Misoprostol
- Progesterone
- Testosterone
- Testosterone Cypionate
- Testosterone Enanthate
- Testosterone Propionate
- Tretinoin
- Voriconazole
If you would like to test for a drug not listed, please email info@arlok.com and request that a new drug be added to our testing library.
Articles:
- USP <800> Environmental Quality and Control
- USP <800> Surface Wipe Sampling
- USP <800> Why should you test?
- USP <800> Environmental Monitoring Requirements Q&A
Webinars:
Drug Diversion is the transfer of licit drugs for illicit purposes. ARL Bio Pharma's investigative services can provide additional evidence of drug diversion. Testing services include: drug identity confirmation, unknown drug identification and drug concentration analysis.
Articles: