(1999; 168 pages) [Spanish]
Starting material specifications should be organized to separate those tests that are routine from those that are performed infrequently or only for new suppliers. Relevant pharmacopoeial monographs, when available, provide a basis for the development of internal manufacturer's specifications.
A positive identification test uniquely applicable to the excipients should be established through analytical technology, such as infrared spectrophotometry and chromatography.
It is important that manufacturers identify and set appropriate limits for impurities. These limits should be based upon appropriate toxicological data, or limits described in national compendial requirements. Manufacturing processes should be adequately controlled so that the impurities do not exceed such established specifications.
Many excipients are extracted from or purified by the use of organic solvents. These solvents are normally removed by drying the moist excipient. In view of the varying and sometimes unknown toxicity of solvents, it is important that excipient specifications include tests and limits for residues of solvents and other reactants.
Container specifications should be established for all excipients to assure consistency in protecting the product during transport from the excipient manufacturer to the pharmaceutical producer. The specifications should not only provide for containers that maintain the stability of the product, but should also meet requirements for protection during shipping, against insect infestation, during handling, etc.