Parenterals (Small And Large Volume) – authorSTREAM Presentation. Formulation of Parenteral: Therapeutic agents Vehicles Water Water. Small volume parenterals. (SVP). Large volume parenterals. (LVP). Formulation of Injections. Volume of Injection. Injected by a syringe. Administered by an. Large Volume Parenterals (LVPs). USP Workshop Packaged in glass bottles or in large volume flexible Preparation of Parenteral Nutrition Formulations. 9.

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Structure of endotoxins Produced mostly by gram-negative bacteria Endotoxin – complex of pyrogenic lipopolysaccharidea protein and inert lipid; lipid part of the lipopolysaccharide is the main pyrogenic agent; polysaccharide part increases solubility Weight variation or content uniformity test This test is intended for sterile solids used for parenteral preparation.


The preparations intended for parenteral use should be free form particulate matter and should be clear when inspected visually. It ovlume also water for injection, which is sterilized and doesnot contain any anti microbial agent or any other substance. The test method for sterility of the product Membrane filtration Direct inoculation of the culture medium Total Parenteral Nutrition TPN may be defined as provision of nutrition for metabolic requirements and growth through the parenteral route.

Particulate matter in injections 3. Sampling Selection of the samples Sample size 65 Minimum number of items to be tested: Filtration may be defined as the separaton of undissolved particles from a liquid by passing a solution through a septum or porous medium that allows the liquid to pass but retains the particles. Even the trace amount of impurities cause instability.


Culture conditions Factors affecting growth largs bacteria Phases of bacterial growth Culture media for sterility testing Fexible polyethylene containers are used for ophthalmic solutions to be administered in drops.

Establishing a practice standard for compounding sterile preparations in pharmacy. Filling of solution in or product in ampoule or vial 7. In-process assays may be performed for one or more ions or other substances and adjustments in solute concentrations made as required before dilution to final prescribed volume Analytical methods performed as in-process assays must be precise and accurate. Sources of pyrogen contamination: Minimum number of items to be tested The weight of 10 individual sterile units is noted and the content is removed from them and empty individual sterile unit is weighed intern.

Cyclo parneterals, Tween twenty and Tween eighty are complexing agents and Surfactants respectively.

Sodium chloride injection IP: Fluid thioglycollate medium Soya-bean casein digest medium other media 49 1. Mechanism of LAL the test is based on the primitive blood-clotting mechanism of the horseshoe crab enzymes located with the crab’s amebocyte blood cells endotoxins initiation of an enzymatic coagulation cascade proteinaceous gel Study of microbiology of water is imp, because water is used for cleansing the equipment before and after manufacture of parenterals.

Preservatives prevent the growth of micro organisms.


Some solutions may require heat to effect dissolution of the solutes for example: Duration of action can be prolonged by modifying formulation. Glass containers require an elastomeric closure.

Surface treatment with silicone fluid siliconization is carried out by applyinglow concentrations via spraying, wiping or dipping of either a solvent or emulsion based solution containing silicone fluid to a clean, dry surface. Minimum number of items to be tested 66 Instead of the conclusion – Guidelines for using the test for sterility: With the development in the field of bio-technology there is a patenterals in the number of drugs administered parenterally.


Tests for pyrogenic activity: Semi-quantitative test method B quantification of bacterial endotoxins in the test solution by titration to an end-point. Presence of contaminants or degradates that effect finished product are considered.

Sterility testing is done to know the sterility of the sterilised material. As a diuretic 33 PowerPoint Presentation: Coulter-counter method and filtration method are used for monitoring particulate matter.

These cartons are designed to facilitate shipping of volum products and to protect containers from physical damage. These generally provide electrolytes, nutrition to the body. Soya-bean casein digest medium: The LAL reagent is used for gel-clot formation.