The parenteral preparations should be free from all types of micro – organisms. An aseptic conditions are required to be maintained during the preparation of Parenteral products and its administration. The parenteral product must pass the test of Sterility. 3 Free from pyrogens.

Small-volume parenteral solutions (SVPs) – a solution volume of 100 mL (as defined by USP) or less that is intended for intermittent intravenous administration (usually defined as an infusion time not lasting longer than 6-8 hours).

Small volume parenteral (SVP) solutions are usually 100 ml or less and are packaged in different ways depending on the intended use. Powdered drugs are supplied in vials and must be constituted (dissolved in a suitable liquid) before being added to any solution.

Small Volume Parenterals in the 2 to 5 mL range most commonly utilize a luer lock or luer slip fit (vented luer) top geometry. Syringes can be connected directly to the ampoules without a needle, creating an inherently safer delivery method.

A large volume parenteral (LVP) is a unit dose container of greater than 100ml that is terminally sterilized by heat. Small volume parenteral (SVP) is a “catch-all” for all non-LVP parenterals products except biologicals.

Parenteral preparations are defined as solutions, suspensions, emulsions for injection or infusion, powders for injection or infusion, gels for injection and implants. They are sterile preparations intended to be administrated directly into the systemic circulation in human or animal body.

Introduction. Parenteral preparations are defined as solutions, suspensions, emulsions for injection or infusion, powders for injection or infusion, gels for injection and implants. 1. They are sterile preparations intended to be administrated directly into the systemic circulation in humans or animals.

USP. ‹755› Minimum Fill test applies to liquids, semisolids, and solids such as creams, gels, jellies, lotions, ointments, pastes, powders, and aerosols, including pressurized and nonpressurized topical sprays that are packaged in containers in which the labeled amount is not more than 150 g or 150 mL (1).

Each container of an Injection is filled with a volume in slight excess of the labeled “size” or that volume that is to be withdrawn. The excess volumes recommended in the accompanying table are usually sufficient to permit withdrawal and administration of the labeled volumes.

A suitable preservative system is required in all multiple-dose parenteral products to inhibit the growth of micro-organisms accidentally introduced during withdrawal of individual doses.

Parenteral formulations are intended to be administered as an injection or infusion. Parenteral preparations include solutions, suspensions, emulsions, powders, and gels.