Table 2.

Impurities and specific tests for PS20 and PS80.

Pharmacopoeia	Polysorbate	Ph. Eur.	USP	JP	ChP
Peroxide value / mEq·kg-1	PS20	≤10	≤5	-	≤10
	PS80	≤10	≤10	≤10	≤3
Heavy metal / ppm	PS20	≤10a	≤10	-	≤10
	PS80	≤10a	≤10a	≤20	≤10
Endotoxins / EU	PS20	-	-	-	-
	PS80	-	-	-	0.012
Acid value / mgKOH·g-1	PS20	≤2	≤2	≤4	≤2
	PS80	≤2	≤2	≤2	≤1
Hydroxyl value / mgKOH·g-1acetylated	PS20	96–108	96–108	-	96–108
	PS80	65–80	65–80	65–80	65–80
Saponification value / mgKOH·g-1	PS20	40–50	40–50	43–55	40–50
	PS80	45–55	45–55	45–55	45–55
Ethylene oxide / ppm	PS20	≤1	≤1	-	≤1
	PS80	≤1	≤1	≤1	≤1

^aLimits deleted since Ph. Eur. 9.0 and since 01.01.2018 (USP)