Theme VII: Analysis of extracts
Fluid extracts are liquid preparations such that 1 part per mass or volume is equivalent to 1 part per mass or plant drug or dry animal tissue.
These preparations are adjusted, if necessary, so as to meet the requirements for solvent content and, where applicable, constituents.
Fluid extracts are prepared using appropriate concentration of ethanol or water to extract the drug plant or animal tissue, or by dilution of a dense or dry extract of plant or animal drug (which has been produced using the same solvent at the same percentage or degree used during the direct extraction process or the preparation of the liquid extract), with alcohol of appropriate concentration or water.
Fluid extracts can be filtered, if necessary. May be present a slight sediment which is acceptable if the composition of the fluid extract doesn’t change significantly.
- Relative density: as value described in the monograph.
- Alcohol content: For alcoholic liquid extracts, proceed to determining the alcohol content. The alcohol content must meet to what is prescribed.
- Methanol and 2 - propanol.
- Dry residue: where applicable, fluid extract meets to the limits prescribed in the monograph, corrected if necessary, taking into account any excipient used.
Protected from light.
The labeled must contain in addition to the requirements listed above the following: where applicable, the alcohol content in percentage V / V of the final extract.