USP <61>, <62> Test Descriptions

USP <61> Acceptance criteria for nonsterile pharmaceutical substances per dosage forms per USP <1111> USP <62> Acceptance criteria for nonsterile pharmaceutical substances per dosage forms per USP <1111>

Route of Admission

Test Code

Description

Suitability and Validation <61/62>

MEP100

The validation and suitability testing are performed once for each product. The testing verifies the validity of the testing method by demonstrating any antimicrobial properties of the product do not inhibit possible recovery of growth. Total Aerobic Microbial Counts: 1000 CFU/g or CFU/mL The USP <61> and <62> tests are designed to validate and determine the quantitation of organisms present and screen for the presence or absence of objectionable organisms.

Non-aqueous for oral use

MEP205 Total Yeasts and Molds Counts: 100 CFU/g or CFU/mL Total Aerobic Microbial Counts: 100 CFU/g or CFU/mL

Absence of Escherichia coli in 1 gram/mL

Aqueous for oral use

MEP205 Total Yeasts and Molds Counts: 100 CFU/g or CFU/mL Total Aerobic Microbial Counts: 100 CFU/g or CFU/mL

Absence of Escherichia coli in 1 gram/mL

The USP <61> and <62> tests are designed to validate and determine the quantitation of organisms present and screen for the presence or absence of objectionable organisms.

Inhalation Use

MEP210 Total Yeasts and Molds Counts: 10 CFU/g or CFU/mL Total Aerobic Microbial Counts: 100 CFU/g or CFU/mL

Absence of Staphylococcus aureus, Pseudomonas aeruginosa, and biletolerant Gram-negative bacteria in 1 gram/mL Absence of Staphylococcus aureus and Pseudomonas aeruginosa in 1 patch

The USP <61> and <62> tests are designed to validate and determine the quantitation of organisms present and screen for the presence or absence of objectionable organisms.

Transdermal Patches

MEP215

The USP <61> and <62> tests are designed to validate and determine the quantitation of organisms present and screen for the presence or absence of objectionable organisms.

Total Yeasts and Molds Counts: 10 CFU/g or CFU/mL Total Aerobic Microbial Counts: 1000 CFU/g or CFU/mL

Rectal Use

MEP220 Total Yeasts and Molds Counts: 100 CFU/g or CFU/mL Total Aerobic Microbial Counts: 100 CFU/g or CFU/mL

N/A

The USP <61> test is designed to validate and determine the quantitation of organisms present. The USP <61> and <62> tests are designed to validate and determine the quantitation of organisms present and screen for the presence or absence of objectionable organisms.

Vaginal Use

MEP225 Total Yeasts and Molds Counts: 10 CFU/g or CFU/mL Total Aerobic Microbial Counts: 100 CFU/g or CFU/mL MEP230 Total Yeasts and Molds Counts: 10 CFU/g or CFU/mL

Absence of Staphylococcus aureus, Pseudomonas aeruginosa and Candida albicans in 1 gram/mL

Other Oromucosal, gingival, cutaneous, nasal, or auricular use

Absence of Staphylococcus aureus and Pseudomonas aeruginosa in 1 gram/mL

The USP <61> and <62> tests are designed to validate and determine the quantitation of organisms present and screen for the presence or absence of objectionable organisms.

P.O. Box 571830 | Murray, UT 84157-1830 6280 S Redwood Road | Salt Lake City, UT 841236600 www.nelsonlabs.com Telephone 801 290 7500 Fax 801 290 7998 sales@nelsonlabs.com

USP <61>, <62> Test Descriptions

<62>

Test code

Organisms All 7 organisms: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, bile-tolerant Gram-negative bacteria, Clostridia, Salmonella and Candida albicans Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, bile-tolerant Gram-negative bacteria, Clostridia, Salmonella and/or Candida albicans Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, bile-tolerant Gram-negative bacteria, Clostridia, Salmonella and/or Candida albicans

Description The USP <62> suitability testing is performed once for each product. The testing verifies the validity of the testing method by demonstrating any antimicrobial properties of the product do not inhibit possible recovery of growth during the test for specified microorganisms. The suitability test demonstratives recovery of Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, bile-tolerant Gram-negative bacteria, Clostridia, Salmonella and Candida albicans The USP <62> suitability testing is performed once for each product. The testing verifies the validity of the testing method by demonstrating any antimicrobial properties of the product do not inhibit possible recovery of growth during the test for specified microorganisms. The suitability test demonstratives recovery of Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, bile-tolerant Gram-negative bacteria, Clostridia, Salmonella and/or Candida albicans

MEP105

Suitability <62>

MEP110

Routine <62> Per organism

MEP235

The USP <62> routine the test for specified microorganisms; Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, bile-tolerant Gram-negative bacteria, Clostridia, Salmonella and/or Candida albicans

<61>

Test Code

Description The USP <61> plate count validation testing is performed once for each product. The testing verifies the validity of the testing method by demonstrating any antimicrobial properties of the product do not inhibit possible recovery of growth during the total aerobic microbial and total yeasts and molds counts.

Validation <61>

MEP115

Routine <61> Filtration

MEP250

USP <61> testing to determine the total aerobic microbial and total yeasts and molds counts performed with the membrane filtration method.

Routine <61> Pour Plate

MEP255

USP <61> testing to determine the total aerobic microbial and total yeasts and molds counts performed with the pour plate method.

Routine <61> Spread Plate

MEP260

USP <61> testing to determine the total aerobic microbial and total yeasts and molds counts performed with the surface spread method.

Routine <61> TAMC or TYMC

MEP265

USP <61> testing to determine the total aerobic microbial counts or total yeasts and molds counts testing.

P.O. Box 571830 | Murray, UT 84157-1830 6280 S Redwood Road | Salt Lake City, UT 841236600 www.nelsonlabs.com Telephone 801 290 7500 Fax 801 290 7998 sales@nelsonlabs.com