Definition of parenteral products
Parenteral products are considered to be the sterile solutions, suspension or emulsions that
are administrated by hypodermic injection either in the form in which they are supplied or
after the addition of suitable solvent or suspending agent.
General requirements for parenteral dosage forms.
i) Free from foreign particles: It should be free from foreign particles, fibres
and filaments.
ii) Sterility: It should be free from all type of microorganisms.
iii) Isotonicity: The preparation should be isotonic with blood plasma and body fluids.
iv) Free from pyrogen: It should be free from pyrogens.
v) Chemical purity: It should be free from chemical impurities or it should be within
certain limit (as specified by the pharmacopeia).
vi) Stability: It should be physically and chemically stable.
vii) Specific gravity: The specific gravity of preparation if it is meant for intra spinal route should be same as spinal fluid.
Enlist various steps involved in processing of parenteral products.
Cleaning of containers, closures and equipment.
Collection of materials.
Preparation of parenteral products.
Filtration.
Filling the preparation in final containers.
Sterilisation.
Evaluation of parenteral preparations.
Labelling and packaging.