Analytical Testing

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
• 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

USP, EP, BP and JP compendial testing qualifies drug substances and excipients as well as drug products to meet pharmacopeia specifications. Testing consists of procedures and acceptance criteria that help ensure the identity, strength, quality, and purity of the article

Articles:

• The Importance of Testing Bulk Substances
• Importance of Testing Raw Material Components

Webinars:

• Raw Materials Revealed
• Regulatory and Quality Considerations in the Selection of API

ARL Bio Pharma has extensive experience in analytical method development/validation for a variety of drug substances and products.

Our laboratory validates analytical methods based on ICH and USP guidelines and high-quality industry practices. Method parameters may include: precision, limit of detection, limit of quantitation, accuracy, linear range, specificity, robustness, system suitability, ruggedness and freeze-thaw.

A particulate matter tests for the presence of extraneous substances including: dust, glass, drug precipitates, rubber and other insoluble materials.

Articles:

• Ophthalmic Medication and Particulate Matter
• Particulate Matter – What is It and What are the Concerns?
• Particulate Matter in Injections What is It and What are the Concerns
• Particulate Matter Testing

Quality tests to ensure proper performance of the formulation, generally solid oral dose forms such as tablets and capsules.

Also known as y-site studies, compatibility testing is performed to ensure that the mixing of two different formulations does not impact the physical or chemical properties of the drugs.

Articles:

• 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
• Palonosetron Hydrochloride Compatibility and Stability with Three Beta-Lactam Antibiotics During Simulated Y-Site Administration

A PK/PD study analyzes the rate and extent of absorption of the active ingredient or moiety and emphasizes the use of pharmacokinetic endpoints in an accessible biological matrix, such as blood, plasma, and/or serum, to indicate release of the drug substance from the drug product into the systemic circulation.

ARL Bio Pharma has extensive experience with chemical, manufacturing and controls testing for original and abbreviated new drug applications. This testing includes: identification tests, quantitative tests for impurities content, limit tests for the control of impurities, performance tests such as dissolution, and quantitative tests of the active moiety in samples of drug substance or drug product or other selected component(s) in the drug product.

ARL Bio Pharma can provide characterization of a biological product (includes determination of physiochemical properties, biological activity, immunochemical properties, purity and impurities) by appropriate techniques as necessary to allow relevant specifications to be established.

This test measures the level of hazardous drug surface residue to verify workplace safety.

Available Drugs:

• 5-Fluorouracil
• Estriol
• Estradiol
• Estrone
• Finasteride
• Medroxyprogesterone Acetate 
• Methotrexate
• Mitomycin
• Misoprostol
• Progesterone
• Testosterone
• Testosterone Cypionate
• Testosterone Enanthate
• Testosterone Propionate
• 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:

• USP <800> Update: What is the Current Status and How do Pharmacists Proceed? 
• Compounding Lab Design and Engineering Considerations per USP 800 Guidelines

Water activity refers to the water in a drug product freely available to participate in reactions such as hydrolysis or provide an environment that supports microbiological growth.

Water activity is measured by calculating the vapor pressure of water in the test sample relative to the vapor pressure of pure water at the same temperature. ARL’s water activity instrument uses a chilled dew point sensor to measure water activity with ± 0.003 accuracy.

Articles:

• Water Activity