This test measures the concentration of the active ingredient at a specific point in time. GMP potency testing uses laboratory methods developed and validated for client specific formulations.
Articles:
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 is performed to ensure contamination can be detected under the conditions of the test, providing confidence in the test result.
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. Rapid test provides objective results in as little as six days. Method suitability is performed to ensure contamination can be detected under the conditions of the test, providing confidence in the test result.
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. Method validation is available to ensure the ideal test method is used consistently, and the most accurate results are reported.
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:
A particulate matter tests for the presence of extraneous substances including: dust, glass, drug precipitates, rubber and other insoluble materials.
Articles:
An antimicrobial effectiveness test demonstrates the effectiveness of antimicrobial preservatives in preventing microbial proliferation in injections, topicals, oral products, and 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. This is commonly referred to as bioburden testing.
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
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
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:
This test measures the degree of uniformity in the amount of the drug substance among dosage units. It is based on assay of individual content of drug substance(s) in a number of dosage units to determine whether the individual content is within the specified limits.