APR January/February 2022 - 17

« MICROBIOLOGY
USP <3> Topical and Transdermal
Drug Products-Product
Quality Tests
Microbial Limits
The chapter states: " Microbial examination of non-sterile drug products
is performed according to the methods given in Microbial Enumeration
Tests <61> and Tests for Specified Microorganisms <62>, unless the
formulation itself is demonstrated to have antimicrobial properties.
Acceptance criteria for non-sterile pharmaceutical products based on
total aerobic microbial count and total combined yeasts and molds
count are given in Microbiological Examination of Non-sterile Products:
Acceptance Criteria for Pharmaceutical Preparations and Substances for
Pharmaceutical Use <1111>. "
As aqueous topical drug products may contain Burkholderia cepacia
that may overcome the antimicrobial preservative system, the newer
chapter Test for Burkholderia cepacia complex <60> that became official
in December 2019 should be cited in <3>.
Sterility
The chapter states: " Depending on the use of the dosage form (e.g.,
products that will be applied to open wounds or burned areas),
sterility of the product should be demonstrated as appropriate (see
Sterility Tests <71>). "
USP <4> Mucosal Drug Products-
Product Quality Tests
Otic Route
The chapter states: " The otic route is characterized by administration of
a preparation into, or by way of, the ear. Demonstration of sterility (see
Sterility Tests <71>) is not always required for products delivered to the
ear. Typically, sterility is required where the product is administered
to the inner ear or where the eardrum is damaged. Where sterility is
not required, the quantitative enumeration of mesophilic bacteria and
fungi that grow under anaerobic (sic) conditions, Microbial Enumeration
Tests <61>, or the determination of the absence or limited occurrence
of specified organisms, Tests for Specified Microorganisms <62>, may
be required. "
This section mistakenly describes the enumeration as being conducted
under anaerobic not aerobic conditions.
Ophthalmic Route
The chapter states: " The ophthalmic route is to the eye. In addition
to the generally necessary tests, the following specific tests for
ophthalmic drug products should be considered (see Table 1), for
products that are injected or implanted into the eye (see ICH Q3B (R2)
Impurities in New Drug Products, 2006). Some of the important product
quality tests for products administered by the ophthalmic route are
listed below. See Ophthalmic Products - Quality Tests <771> for details
and other product quality information. "
www.americanpharmaceuticalreview.com |
| 17
»
http://www.americanpharmaceuticalreview.com

APR January/February 2022

Table of Contents for the Digital Edition of APR January/February 2022

APR January/February 2022 - Cover1
APR January/February 2022 - Cover2
APR January/February 2022 - 1
APR January/February 2022 - 2
APR January/February 2022 - 3
APR January/February 2022 - 4
APR January/February 2022 - 5
APR January/February 2022 - 6
APR January/February 2022 - 7
APR January/February 2022 - 8
APR January/February 2022 - 9
APR January/February 2022 - 10
APR January/February 2022 - 11
APR January/February 2022 - 12
APR January/February 2022 - 13
APR January/February 2022 - 14
APR January/February 2022 - 15
APR January/February 2022 - 16
APR January/February 2022 - 17
APR January/February 2022 - 18
APR January/February 2022 - 19
APR January/February 2022 - 20
APR January/February 2022 - 21
APR January/February 2022 - 22
APR January/February 2022 - 23
APR January/February 2022 - 24
APR January/February 2022 - 25
APR January/February 2022 - 26
APR January/February 2022 - 27
APR January/February 2022 - 28
APR January/February 2022 - 29
APR January/February 2022 - 30
APR January/February 2022 - 31
APR January/February 2022 - 32
APR January/February 2022 - 33
APR January/February 2022 - 34
APR January/February 2022 - 35
APR January/February 2022 - 36
APR January/February 2022 - 37
APR January/February 2022 - 38
APR January/February 2022 - 39
APR January/February 2022 - 40
APR January/February 2022 - 41
APR January/February 2022 - 42
APR January/February 2022 - 43
APR January/February 2022 - 44
APR January/February 2022 - 45
APR January/February 2022 - 46
APR January/February 2022 - 47
APR January/February 2022 - 48
APR January/February 2022 - 49
APR January/February 2022 - 50
APR January/February 2022 - 51
APR January/February 2022 - 52
APR January/February 2022 - 53
APR January/February 2022 - 54
APR January/February 2022 - 55
APR January/February 2022 - 56
APR January/February 2022 - 57
APR January/February 2022 - 58
APR January/February 2022 - 59
APR January/February 2022 - 60
APR January/February 2022 - 61
APR January/February 2022 - 62
APR January/February 2022 - 63
APR January/February 2022 - 64
APR January/February 2022 - 65
APR January/February 2022 - 66
APR January/February 2022 - 67
APR January/February 2022 - 68
APR January/February 2022 - 69
APR January/February 2022 - 70
APR January/February 2022 - 71
APR January/February 2022 - 72
APR January/February 2022 - 73
APR January/February 2022 - 74
APR January/February 2022 - 75
APR January/February 2022 - 76
APR January/February 2022 - 77
APR January/February 2022 - 78
APR January/February 2022 - 79
APR January/February 2022 - 80
APR January/February 2022 - 81
APR January/February 2022 - 82
APR January/February 2022 - 83
APR January/February 2022 - 84
APR January/February 2022 - Cover3
APR January/February 2022 - Cover4
https://www.nxtbookmedia.com