Pharmacy

This test measures the concentration of the active ingredient at a specific point in time.

• Benefits of Submitting Master Formulation Records
• Potency Test Failure Case Studies
• Drug Formulation and Its Impact on Analytical Testing
• Stability vs. Potency Testing
• Potency Testing Benefits and Requirements

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).

• Importance of Forced Degradation in Stability Indicating Methods
• Stability vs. Potency Testing
• Extending Beyond Use Dating for Compounded Preparations

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.

• Method Suitability and Its Importance to the Test Method
• Sterility Test Failure: Possible Causes and Investigation
• Basics of Sterility Testing
• Open vs Closed Membrane Filtration Systems
• USP 71 Sterility Testing

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. Rapid test provides objective results in as little as six days.

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• Rapid Sterility Testing

An endotoxin test detects toxins that are released from the cell wall of disrupted gram-negative bacteria.

• The Importance of Endotoxin Testing

This test is designed to increase the likelihood of detecting fungal microorganisms in sterile products. 

This test identifies microorganisms isolated during different phases of manufacturing and quality testing to the genus/species level using DNA sequencing.

• Prevent Future Sterility Failures by Identifying Contaminating Microorganisms
• How Does Microbial ID Benefit Your Pharmacy?

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.

• The Essentials of USP <51>

These tests quantitate the total population of aerobic bacteria and yeast and molds in raw materials, in-process samples, finished products.

These tests verify the absence of objectionable microorganisms in drug products and raw materials.

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

• Particulate Matter Testing

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.

• Microbial Disinfectant Cleaning Challenge Studies

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

Available drugs:

• Estriol

• Estradiol

• Estrone

• Testosterone

• Progesterone

• Testosterone Propionate

• Testosterone enanthate

• Testosterone Cypionate

• Methotrexate

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Article: USP800 Why should you test