Page 304 - Applied Pharmacognosy

Types of Chemical markers

 The chemicals and raw materials .
 Equipment used in the preparation of the product.

Maximum acceptable endotoxin level

 Endotoxin levels are measured in endotoxin units
(EU). One EU is approximately equivalent to 100pg
of E. coli lipopolysaccharide – the amount present
in around 105 bacteria.
 The FDA has set the following maximum
permissible endotoxin levels for drugs distributed
in the United States: