Pyrogens definition

Fig. 15. Schematic of pyrogenic siUca production (54). See Figure 13 for definitions.

Water for injection (WFI) is the most widely used solvent for parenteral preparations. The USP requirements for WFI and purified water have been recently updated to replace the traditional wet and colorimetric analytical methods with the more modern and cost-effective methods of conductivity and total organic carbon. Water for injection must be prepared and stored in a manner to ensure purity and freedom from pyrogens. The most common means of obtaining WFI is by the distillation of deionized water. This is the only method of preparation permitted by the European Pharmacopoeia (EP). In contrast, the USP and the Japanese Pharmacopeias also permit reverse osmosis to be used. The USP has also recently broadened its definition of source water to include not only the U.S. Environmental Protection Agency National Primary Drinking Water Standards, but also comparable regulations of the European Union or Japan. 

Silica is one of the most abundant chemical substances on earth. It can be both crystalline or amorphous. The crystalline forms of silica are quartz, cristobalite, and tridymite [51,52]. The amorphous forms, which are normally porous [149] are precipitated silica, silica gel, colloidal silica sols, and pyrogenic silica [150-156], According to the definition of the International Union of Pure and Applied Chemistry (IUPAC), porous materials can be classified as follows microporous materials are those with pore diameters from 3 to 20 A mesoporous materials are those that have pore diameters between 20 and 500 A and macroporous materials are those with pores bigger than 500 A [149],... 

Perfect spheres are rare, but spheroidal particles are present in some powders produced at high temperature (e.g. pyrogenic silicas) or by the sol-gel process. The term sphericity is useful for some purposes. Sphericity has been defined in various ways, the simplest definition being the ratio of the surface area of a sphere of the same volume as a given particle to the actual surface area of that particle (Allen, 1990). 

In fig. 1.26 the effect of sample pretreatment is illustrated. The original sample is "Cab-0-Sir, a pyrogenic silica. It has a fairly low affinity for water. The isotherm type is between II and III (fig. 1.13). No hysteresis is observed. Stronger outgasslng (fig. (b)), further reduces the affinity for water the curve is now definitely of type II but also shows considerable hysteresis which was attributed to incomplete hydroxylation. In case (c) the surface is made hydro-phobic by methylatlon. The water adsorption isotherm (not shown) remains of type II but as Nj adsorption is not determined by hydrophilic groups, the corresponding Isotherm is of type III. Again, it is hysteresis-free. By application of the theories outlined before, information can be extracted from these isotherms in terms of available areas and enthalpies of adsorption. The authors extended this work with infrared studies. 

Processes of this sort have been classified under the general name of pyrogenic decomposition and may be differentiated into two types (1) those which take place under the action of heat alone, and (2) those which take place under the action of heat in the presence of a catalyst. Tn the former case the product of the reaction frequently consists of a very complex mixture, the character of which is determined by the temperature, pressure and time of contact.8 In the latter case, the course of the reaction may in certain instances be so controlled as to favor the formation of a single product. The procedure may be varied by passing the vapor of the substance through a tube or chamber the walls of which arc themselves inactive but into which an appropriate catalyst has been introduced. This latter modification of the reaction has been made the. subject of careful investigation by Ipatiew, who was indeed the first to call attention to the definite quantitative differences in the amounts of (a) acetaldehyde and (b) ethylene which resulted from the pyrogenic decomposition of ethanol under the action of specific catalysts. 

It is difficult to define precisely the term aqueous silica sols and thereby contrast them with other forms of silica (colloidal silica, colloidal quartz, pyrogenic silica, and so forth). Bulk chemical distinctions are not very useful. The definition chosen here follows Iler s terminology (I). Aqueous silica sols are characteristically composed of spherical particles nucleated and grown by alkaline hydrolysis of sodium silicate solutions. They are often monodisperse systems and have particle diameters in the range 1-100 nm (density, —2.2 g/cm3) that lead to sols that vary from optically transparent to opalescent. 

Adsorptive properties of porous silicas compacts of pyrogenic powders, 506, 507f precipitated silicas, 507-509 silica gels, 509, 510-512 zeolitic silicas, 512-514 Adsorptive properties of silicas, challenges for improvement, 505 Aerogel(s) definition, 7, 620 porosities, 379, 380 ... 

CAS 112945-52-5 EINECS/ELINCS 231-545-4 Synonyms Amorphous silica dust Cl 77711 Colloidal silica Colloidal silicon dioxide Eossil flour Eumed silica Fumed silicon dioxide Pigment white 27 Silica, amorphous Silica, amorphous fumed Silica, pyrogenic Silicic anhydride Silicon dioxide Definition High surface area aggregate particles of silica, with min. 89.5% SiOj content Empirical OjSi Formula SiOj... 

For dosage forms for parenteral administration the Ph. Eur. sets hmits for bacterial endotoxins and pyrogens. For definition and difference see Sect. 19.3.4. Ph. Eur. chapter 2.6.14 Bacterial endotoxins describes six different methods of which the LAL test (gel-clot-method) is the... 

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