What are the general requirements of Parenteral Products?

General requirements of parenteral products are:

(i) Sterility,

(ii) Freedom from physical and chemical contaminants,

(iii) Freedom from microbial products such as toxins, pyrogens etc.

(iv) Isotonicity and

(v) matching of specific gravity with the body fluid(s).

The general requirements of parenteral products lead to a difficult problem of selection of the vehicle, additives, stabilizers, buffers, preservatives, containers and closures, a reliable method of sterilization and measures to check the sterility, physical and chemical contamination, pyrogenicity etc., for the product. However, as a rule, one should always endeavor to use minimum number of essential additives in smallest possible quantities.