ARL Bio Pharma provides analytical and microbiological testing for California compounding pharmacies, outsourcing facilities, and health-system pharmacies. Our laboratory partners with California Pharmacy Association so pharmacies can meet state quality requirements and release safe, effective drug products easier and faster.
CPhA members also receive a 10% discount on testing services.
Submit Samples for testing through ARL's Client Portal. Make sure to write "CPhA Member" on required new client forms to receive 10% discount.
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 Results
- Potency Testing Benefits and Requirements
- Stability vs. Potency Testing
- T3/T4 Formulations
- Test Specifications
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
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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:
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
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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:
These tests quantitate the total population of aerobic bacteria, yeast, and molds in raw materials, in-process samples, and finished products.
Articles:
- Microbial Tests for Non-Sterile Products
- Microbial Limit Tests for Nonsterile Pharmaceuticals Part 1
- Microbial Limit Tests for Nonsterile Pharmaceuticals-Part 2
- Minor Chapters, Major Impacts – What USP Chapters 51, 61, 62, and 1207 Mean for Your Compounding Practice
- USP <61> and USP <62> Microbial Tests for Non-Sterile Products
Webinars
- Microbiology Testing: USP Requirements for Sterile and Non-Sterile Preparations
- Minor Chapters, Major Impacts: What USP <51>, <61>, <62>, and <1207> mean for your Practice
These tests verify the absence of objectionable microorganisms in drug products and raw materials.
Articles:
- Microbial Tests for Non-Sterile Products
- Microbial Limit Tests for Nonsterile Pharmaceuticals Part 1
- Microbial Limit Tests for Nonsterile Pharmaceuticals-Part 2
- Minor Chapters, Major Impacts – What USP Chapters 51, 61, 62, and 1207 Mean for Your Compounding Practice
- USP <61> and USP <62> Microbial Tests for Non-Sterile Products
Webinars
- Microbiology Testing: USP Requirements for Sterile and Non-Sterile Preparations
- Minor Chapters, Major Impacts: What USP <51>, <61>, <62>, and <1207> mean for your Practice
Microbiological Examination of Nonsterile Products – Tests for Burkholderia cepacia Complex USP <60>
This test procedure evaluates the microbiological quality, specifically the presence of species of the genus Burkholderia, in non-sterile substances and preparations. This is important, because Burkholderia is a potentially dangerous pathogen, especially for drugs or raw materials that are intended for inhalation use, and aqueous preparations for oral, oromucosal, cutaneous, or nasal administration.
Articles:
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: Estriol, Estradiol, Estrone, Finasteride, Methotrexate, Mitomycin, Progesterone, Testosterone, Testosterone Cypionate, Testosterone enanthate, and Testosterone Propionate.
Articles:
- USP <800> Surface Wipe Sampling
- USP <800> Why should you test?
- USP <800> Environmental Monitoring Requirements Q&A
Webinars: