Pharmaceutical specification

RINGDOC Pharmaceutical Literature Documentation approx. 450,000 1976-present DERWENT PUBLICATIONS LIMITED Covers scientific journal literature on pharmaceuticals. Specifically designed to meet the information requirements of manufacturers. Includes papers from over 750 worldwide journals... 

The purification process was scaled up 10-fold from 100 to 1000 cm2 of stacked 142 mm disks. The scale-up exhibited a good separation with a 7 log reduction in endotoxin levels. The yield was 98% with a final purity of 98.2%. This process was again scaled up with the modular configuration described previously (Fig. 3). Two 30-layer 4 m2 Q modules were used in conjunction with a 1 m2 C module. The chromatograms appeared very similar to the 1000 cm2 purification. The product purity was found to be 99.7% with < 0.002 endotoxin units per microgram of product and 0.003 pg DNA per microgram of product. The final product exceeded the clinical pharmaceutical specifications for this product. 

The general model for a Quality Management System for healthcare establishments ISO 9001/EN 15224 is applicable to the pharmacy as a whole, including pharmacy preparation. All pharmaceutical specificities have to be created, for which the Swiss system [8] may be useful if updated to EN 15224. The 7 Pillars model is applicable to the whole pharmacy as well. If used to preparation terminology, this system offers the advantage of using familiar terminology. 

Reagent-grade urea is used in some pharmaceutical preparations. In these appHcations, urea must meet the purity specifications issued by the ACS. 

Analytical and control methods for acetic anhydride are fully discussed in reference 55. Performance tests are customarily used where the quality of the product is cmcial, as in food or pharmaceutical products. Typical specifications are ... 

Another group of natural flavoring ingredients comprises those obtained by extraction from certain plant products such as vanilla beans, Hcotice root, St. John s bread, orange and lemon peel, coffee, tea, kola nuts, catechu, cherry, elm bark, cocoa nibs, and gentian root. These products are used in the form of alcohohc infusions or tinctures, as concentrations in alcohol, or alcohol—water extractions termed fluid or soHd extracts. Official methods for their preparation and specifications for all products used in pharmaceuticals are described (54,55). There are many flavor extracts for food use for which no official standards exist the properties of these are solely based on suitabiUty for commercial appHcations (56). 

As predictable from the similarity of the properties of the two gums, quince seed gum is used in the appHcations described above for psyllium seed gum. Specific appHcations are in cosmetics and hair-setting lotions. It has also been used as an emulsifier and stabilizer in pharmaceutical preparations. 

The rationale for the development of such fibers is demonstrated by their appHcation in the medical field, notably hemoperfusion, where cartridges loaded with activated charcoal-filled hoUow fiber contact blood. Low molecular weight body wastes diffuse through the fiber walls and are absorbed in the fiber core. In such processes, the blood does not contact the active sorbent direcdy, but faces the nontoxic, blood compatible membrane (see Controlled RELEASE TECHNOLOGY, pharmaceutical). Other uses include waste industrial appHcations as general as chromates and phosphates and as specific as radioactive/nuclear materials. 

Catechol is produced by coproduction with hydroquinone starting from phenol. Other techniques such as coal extraction remain marginal. The installed capacities (- 25,000 t/yr) are now sufficient to cover the demand. Catechol is mainly used for synthesis in food, pharmaceutical, or agrochemical ingredients. A specific appHcation of / fZ-butylcatechol is as a polymerisation inhibitor. 

The fermentation-derived food-grade product is sold in 50, 80, and 88% concentrations the other grades are available in 50 and 88% concentrations. The food-grade product meets the Vood Chemicals Codex III and the pharmaceutical grade meets the FCC and the United States Pharmacopoeia XK specifications (7). Other lactic acid derivatives such as salts and esters are also available in weU-estabhshed product specifications. Standard analytical methods such as titration and Hquid chromatography can be used to determine lactic acid, and other gravimetric and specific tests are used to detect impurities for the product specifications. A standard titration method neutralizes the acid with sodium hydroxide and then back-titrates the acid. An older standard quantitative method for determination of lactic acid was based on oxidation by potassium permanganate to acetaldehyde, which is absorbed in sodium bisulfite and titrated iodometricaHy. 

Particle Shape and Size. With few exceptions, resins are supplied as small, round beads having a diameter between 0.3 and 1.2 mm. Some resins are reduced to a smaller size by grinding to satisfy specific requirements in applications for electric power generation (qv) and pharmaceuticals (qv). 

The US. Pharmacopeia (USP XXII) or National Formula (NFXVII) (20) also provide a similar description however, the peroxide value is not defined (Table 9). These specifications are also given in the Handbook of Pharmaceutical Excipients (HPE), pubhshed jointiy by the American Pharmaceutical Association and The Pharmaceutical Society of Great Britain (21), which defines lecithins both from plants and eggs. The Merck Index (22) specifies a slightiy lower acid value. The Japanese Monograph (ISCI-II) (23) specifies a slightiy lower acetone-insoluble matter and a lower heavy-metal content. 

Liposomes. Lecithin, and mote specifically purified phosphohpids, ate used to produce liposomes (39) for the food (40), cosmetics, pharmaceutical, agrochemical, and technical fields. 

The advent of a large international trade in methanol as a chemical feedstock has prompted additional purchase specifications, depending on the end user. Chlorides, which would be potential contaminants from seawater during ocean transport, are common downstream catalyst poisons likely to be excluded. Limitations on iron and sulfur can similarly be expected. Some users are sensitive to specific by-products for a variety of reasons. Eor example, alkaline compounds neutralize MTBE catalysts, and ethanol causes objectionable propionic acid formation in the carbonylation of methanol to acetic acid. Very high purity methanol is available from reagent vendors for small-scale electronic and pharmaceutical appHcations. 

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