The requirements for vegetable and animal substances apply to the articles as they enter commerce; however, lots of such substances intended solely for the manufacture or isolation of volatile oils, alkaloids, glycosides, or other active principles may depart from such requirements.
Statements of the distinctive microscopic structural elements in powdered substances of animal or vegetable origin may be included in the individual monograph as a means of determining identity, quality, or purity.
Vegetable and animal substances are to be free from pathogenic organisms (see Microbiological Attributes of Nonsterile Pharmaceutical Products 1111
), and are to be as free as reasonably practicable from microorganisms, insects, and other animal contamination, including animal excreta. They shall show no abnormal discoloration, abnormal odor, sliminess, or other evidence of deterioration.
The amount of foreign inorganic matter in vegetable or animal substances, estimated as Acid-insoluble ash, shall not exceed 2 percent of the weight of the substance, unless otherwise specified in the individual monograph.
Before vegetable substances are ground or powdered, stones, dust, lumps of soil, and other foreign inorganic matter are to be removed by mechanical or other suitable means.
In commerce it is seldom possible to obtain vegetable substances that are without some adherent or admixed, innocuous, foreign matter, which usually is not detrimental. No poisonous, dangerous, or otherwise noxious foreign matter or residues may be present. Foreign matter includes any part of the plant not specified as constituting the substance.