. 2018 Apr 19;11(2):34. doi: 10.3390/ph11020034

Table 2.

Requirements for pharmaceutical preparations by application type. G⁻: Gram-negative [13,68,69,70,71].

Route of Administration		Total Aerobic Microbial Count (CFU/g or CFU/mL)	Total Combined Yeast/Mold Count (CFU/g or CFU/mL)	Absence of Specific Microorganisms	cGMP Requirement	Defined Endotoxin Limits
Oral	Non-aqueous	10³	10²	E. coli	Yes	No
	Aqueous	10²	10¹	E. coli
	Buccal/Gingival	10²	10¹	S. aureus
Skin	Transdermal	10²	10¹	S. aureus and P. aeruginosa	Yes	No
	Cutaneous	10²	10¹	S. aureus and P. aeruginosa		No
	Injectable	0	0	-		Yes
Vaginal		10²	10¹	S. aureus and P. aeruginosa and Candida albicans	Yes	No
Rectal		10³	10²	-	Yes	No
Inhalation		10²	10¹	S. aureus, P. aeruginosa and bile tolerant G⁻ bacteria	Yes	No