Pharmaceutical Drug USP Test Methods

Pharmaceutical Drug USP Test Methods

Pharmaceutical Drug USP Test Methods
Pharmaceutical Drug USP Test Methods

U.S. Pharmacopeia (USP) is an organization whose main goal is to help improve human health by creating standards to ensure higher quality and safer pharmaceuticals, foods, and dietary supplements (learn more about USP standards). The FDA enforces standards set by USP to ensure the highest quality in consumer products.

The following are USP methods for pharmaceutical drugs:

Antimicrobial Effectiveness Testing

This USP tests a preservatives effectiveness. Preservatives are commonly added to pharmaceutical drugs in an effort to increase the shelf-life of the product and prevent microbial growth.

Microbial Examination of Nonsterile Products: Microbial Enumeration Tests

This test, performed on nonsterile products such as pharmaceuticals, cosmetics, and other personal care items, determines the total aerobic microbial count and the total yeast and mold count of the product. This test helps determine whether harmful organisms are present in high or low numbers.

Microbial Examination of Nonsterile Products: Tests for Specified Microorganisms

In addition to performing microbial enumeration testing on nonsterile products, testing them for specified organisms is also performed due to the fact that some pathogens are harmful even in small numbers.  Tests for specified organisms determine whether the formulation is in compliance with previously established specifications.

Other USP methods for pharmaceutical drugs exist and Contract Laboratory can help you find the right lab for testing! Submit your request USP  Pharmaceutical Test Request or by calling 1-855-377-6821!

The following are test requests we have received for USP methods for pharmaceutical drugs

View more recent requests View more USP Pharmaceutical Test Requestsa:

  • Large Corporation needs Pharmaceutical Microbiology Laboratory needed for USP Testing to USP <51> Antimicrobial Effectiveness Testing and USP <51> Suitability Testing
  • Cosmetic microbiology laboratory needed for antimicrobial effectiveness testing of skincare (topical) product to USP 51 Antimicrobial Effectiveness Testing or ISO 11930.
  • USA FDA GLP Microbiology Laboratory needed for antimicrobial effectiveness testing Neutralization validation. Bacterial enumeration, 10-fold serial dilutions (PBW), pour plated in triplicate (TSA +N). 72 hour incubation, colonies counted.
  • FDA GLP microbiology laboratory needed for ATCC, USP antimicrobial effectiveness testing -Challenge Test
  • LONG-TERM TESTING Small business that manufactures topical homeopathics in small batches needs microbiology laboratory for USP Batch Testing to USP Standards: USP 61 MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: MICROBIAL ENUMERATION TESTS and/or USP 62 MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: TESTS FOR SPECIFIED MICROORGANISMS
  • FDA cGMP microbiology laboratory needed for microbiological and sterility testing of generic drug products (tablets, capsules, and injections) including EP European Pharmacopoeia microorganisms parameter assays, microbial enumeration tests, total aerobic microbial count (TAMC) CFU/g or GFU/ml, total combined yeasts/molds count (TYMC) CFU/g or GFU/ml, microbiological identification, Escherichia coli, Salmonella, Pseudomonas aeruginosa, and Staphylococcus aureus.
  • Medical Device laboratory needed for ASTM and ISO product safety testing for evaluation of medical devices including toxicology, packaging and microbiology testing: ASTM D7661-10, Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms for compliance with latex and polyisoprene condoms. ISO 10993-5 Biological Evaluation of Medical Devices-Part 5: Tests for in vitro cytotoxicity ISO 10993-10 Biological Evaluation of Medical Devices-Part 10: Tests for irritation and skin sensitization ISO 10993-11 Biological Evaluation of Medical Devices-Part 11: Tests for systemic toxicity United States Pharmacopeia, National Formulary General Chapter <88>: Biological Reactivity Tests, In Vivo USP <51> Antimicrobial Effectiveness Testing USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms ISTA 3A: Packaged-Products for Parcel Delivery System Shipment 70 Kg (150 lb) or Less Shelf-life testing
  • Southeast USA Microbiology Laboratory needed for USP Testing to USP 61, Microbial Examination of Nonsterile Products: Microbial Enumeration Tests, on personal care products