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USP <61>, <62> Test Descriptions Route of Admission Test Code USP <61> Acceptance criteria

USP <61>, <62> Test Descriptions

Route of Admission

Test Code

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>

Description

Suitability and Validation

     

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.

<61/62>

MEP100

   

Total Aerobic Microbial Counts:

 

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.

 

1000

CFU/g or CFU/mL

Absence of Escherichia coli in 1 gram/mL

Non-aqueous for oral use

MEP205

Total Yeasts and Molds Counts:

100

CFU/g or CFU/mL

   
   

Total Aerobic Microbial Counts:

 

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.

 

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:

Absence of Staphylococcus aureus, Pseudomonas aeruginosa, and bile- tolerant Gram-negative bacteria 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.

 

100

CFU/g or CFU/mL

Inhalation Use

MEP210

Total Yeasts and Molds Counts:

10

CFU/g or CFU/mL

 
   

Total Aerobic Microbial Counts:

 

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.

 

100

CFU/g or CFU/mL

Absence of Staphylococcus aureus and Pseudomonas aeruginosa in 1 patch

Transdermal Patches

MEP215

Total Yeasts and Molds Counts:

10

CFU/g or CFU/mL

   
   

Total Aerobic Microbial Counts:

   
 

1000

CFU/g or CFU/mL

The USP <61> test is designed to validate and determine the quantitation of organisms present.

Rectal Use

MEP220

Total Yeasts and Molds Counts:

N/A

100

CFU/g or CFU/mL

 
   

Total Aerobic Microbial Counts:

 

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.

 

100

CFU/g or CFU/mL

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

Vaginal Use

MEP225

Total Yeasts and Molds Counts:

10

CFU/g or CFU/mL

   
   

Total Aerobic Microbial Counts:

 

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.

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

 

100

CFU/g or CFU/mL

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

MEP230

Total Yeasts and Molds Counts:

 

10

CFU/g or CFU/mL

   

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 Description    

USP <61>, <62> Test Descriptions

<62>

Test code

Organisms

Description

   

All 7 organisms:

 

Suitability <62>

MEP105

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 Candida albicans

MEP110

Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, bile-tolerant Gram-negative bacteria, Clostridia, Salmonella and/or 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

Routine <62> Per organism

MEP235

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

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

Validation <61>

MEP115

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.

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