USP <61> Microbial Enumeration Tests
GPTKB entity
Statements (29)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
pharmacopeial standard
|
| gptkbp:appliesTo |
raw materials
medical devices pharmaceutical products |
| gptkbp:compatibleWith |
harmonized with JP 4.05
harmonized with Ph. Eur. 2.6.12 |
| gptkbp:describes |
methods for determining total aerobic microbial count
methods for determining total combined yeasts and molds count |
| gptkbp:firstPublished |
2001
|
| gptkbp:focusesOn |
microbial enumeration
|
| https://www.w3.org/2000/01/rdf-schema#label |
USP <61> Microbial Enumeration Tests
|
| gptkbp:includes |
membrane filtration method
most probable number (MPN) method plate count method |
| gptkbp:language |
English
|
| gptkbp:latestReleaseVersion |
USP 43-NF 38 (2020)
|
| gptkbp:partOf |
gptkb:USP-NF_(United_States_Pharmacopeia–National_Formulary)
|
| gptkbp:publishedBy |
gptkb:United_States_Pharmacopeia_(USP)
|
| gptkbp:relatedTo |
gptkb:USP_<62>_Tests_for_Specified_Microorganisms
|
| gptkbp:requires |
growth promotion testing
validation of test methods |
| gptkbp:specifies |
acceptance criteria for microbial counts
|
| gptkbp:usedBy |
medical device industry
pharmaceutical industry cosmetic industry |
| gptkbp:usedFor |
gptkb:legislation
quality control |
| gptkbp:bfsParent |
gptkb:USP_Microbiology_Standards
|
| gptkbp:bfsLayer |
7
|