Raw Materials Monographs

Opdyke, D.L.J. (1975) Fragrance raw materials monographs cinnamaldehyde anthranilate. Food Cosmet. Toxicol., 13, (Suppl. 2), 751-752... 

Anonymous (1974) Fragrance raw materials monographs. Indole. Food and Cosmetics Toxicology 12 925-926. 

Opdyke, D. 1974. Fragrance raw material monographs Rosemary oil. Food Cosmet. Toxicol. 12 977-978. 

Opdyke DLJ (1979) Fragrance raw materials monographs. Food Chem Toxicol 17 375-376... 

D. L. J. Opdyke, ed.. Monographs on Fragrance Raw Materials Research Institute for Eragrance Materials, Pergamon Press, Inc., New York, 1979. 

Described often as a versatile industrial raw material CNSL is cited to have innumerable applications in many areas. The large number of patents [155-157], reports [135], monographs [146], reviews [136,137,153,... 

Non-specific absolute assay methods, e.g. volumetric titration, can be applied to avoid the establishment of a reference substance. This is only appropriate, however, when the monograph describes a separation test for related substances. This approach is certainly valid for the determination of the content of pharmaceutical raw materials but less acceptable for the assay of content of pharmaceutical preparations where the employment of specific assay methods is recommended (ICH Guideline 1994) to take account of decomposition of the active ingredient during the shelf life of the product and to avoid possible interference from excipients. 

Opdyke DLJ Monographs on fragrance raw materials. Food Cosmet Toxicol 12(3) 385-405, 1974... 

D. L. J. Opdyke, Food and Cosmetics Toxicol., 1976, 14 suppl., 659 (Special Issue III Monographs on Fragrance Raw Materials) additional monographs have been published periodically by D. L. J. Opdyke, beginning ibid., 1973, 11, 95. For recent monographs see D. L. J. Opdyke, ibid., 1976, 14, 197, 307,443,601. 

Since the alchemists considered natural antimony minerals to be the most suitable raw material for the transmutation of metals into gold, alchemical literature abounds in references to antimony (65). The most famous of the early monographs on this element is the Triumphal Chariot of Antimony, which first appeared in 1604, in German. Johann Tholde, operator of a saltworks in Frankenhausen, Thuringia, the editor of this work, claimed that it had been written by a fifteenth-century Benedictine monk, Basilius Valentinus (3, 6). Since no conclusive evidence of the existence of this monk has been unearthed, and since the literary style... 

Fenaroli G (1975) Fenarolis Handbook of Flavor Ingredients. CRC, Boca Raton, p 550 Opdyke DLJ (1975) Monographs on fragrance raw materials. y-Nonalactone. Food and Cos-met Toxicol 13 889... 

Bacterial endotoxin analysis is performed on finished product where specihed in the individual monographs of the current USP. Additionally, endotoxin analysis is performed on water for injection, raw materials, and incoming components to detect contamination even in the absence of recovery of viable bacteria. Bacterial endotoxin analysis is performed per current USP, using gel clot analysis or other suitable endotoxin analysis methods (provide reference attachment number). 

Inhibition enhancement validation testing is performed on each raw material and finished product as part of the validation for bacterial endotoxin analysis in accordance with the current USP and the FDA Guidelines. Limits are determined from USP monographs or the FDA Guidelines and are used in calculating the maximum valid dilution (MVD). Serial dilutions are performed of spiked and unspiked product in order to determine the dilution required to overcome inhibition or enhancement (DROIE). If the DROIE does not exceed the MVD, the test is determined to be valid. Confirmation of the DROIE is performed on three finished product or raw material lots in order to complete the product validation. Products are tested at a dilution greater than the DROIE but less than the MVD. 

It is important to assure consistency from lot-to-lot for the desired functionality. While the compendial monograph focuses on chemical characteristics and demonstrates the safety of the raw material, some excipients require functionality tests to assess their performance in the finished drug product. These tests reflect the physical... 

Nichols, L.E. 1979. Packaging and storage of raw materials. In Monograph on Recombination of Milk and Milk Products. Technology and Engineering Aspects. Document 116, pp. 53-55, International Dairy Federation, Bussels. 

It obviously is impossible to provide limits and tests in each monograph for the detection of all possible unusual or unexpected impurities, the presence of which would be inconsistent with good manufacturing practice. The limits and tests provided are those considered to be necessary according to currently recognized methods of manufacture and are based on information available to or provided to the Committee on Food Chemicals Codex. If other methods of manufacture or other than the usual raw materials are used, or if other possible impurities may be present, additional tests may be required and should be applied, as necessary, by the manufacturer, vendor, or user to demonstrate that the substance is suitable for its intended application. 

In conclusion, a procedure makes it possible to avoid duplication of work not only by manufacturers of raw materials and manufacturers of medicines (finished products) when they prepare licensing dossiers but also by the licensing authorities and pharmacopeia authorities when they assess these dossiers. Differences among the various European licensing authorities in approach and assessment of compliance with European Pharmacopeia monographs are also avoided, and clearer communications are facilitated. Finally, the procedure allows European Pharmacopeia monographs to be constantly updated to keep up with new developments in the world market. 

Almost all the main ceramic raw materials belong to the groups of oxides, silicates and carbonates. They were dealt with, especially as regards their behaviour during technological operations, in Chapter I. Further necessary data will be specified in connection with the individual types of ceramics. The problems of ceramic raw materials have been dealt with in detail in specific monographs, for example, by Radczewski (1968) and Grimshaw (1971). 

Wehmer also gives preliminary answers to the question of what species might be suitable sources of a definite compound or product—the type of question that arises when substitute raw materials must be found in times of economic stress or dislocation. Thus, he gives 31 references to the occurrence of berberine in different plants. Apart from sources familiar to all chemists, such as abstract journals, additional references for information of this type can be found in monographs on alkaloids 6, 12),... 

The Pharmacopoeia Department works in collaboration with the European Pharmacopoeia, and draw up monographs for raw materials used in extemporaneous preparations. 

When a homeopathic product has a therapeutic indication, the registration file has to include efficacy. This can be done via monographs or a survey of the literature with regard to the efficacy of the homeopathic raw material and its potencies. 

A monograph on fragrance raw materials has been published " as well as two useful, if dated, collections of papers on essential oils. ... 

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