MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION
Supersedes the XI Monograph of the State Pharmacopoeia
Tincture is a liquid dosage form, which is usually colored alcoholic or hydroalcoholic extracts obtained from herbal medicinal raw materials (dried or fresh), as well as from raw materials of animal origin without heating and removing the extraction solvent.
Tinctures are divided into simple, based on one type of herbal substance, and complex from a mixture of several types of herbal medicinal raw materials.
Tinctures are manufactured by maceration, percolation or other validated method, using ethyl alcohol as an extraction solvent in the required concentration.
From one weight part of herbal substance, 5 parts of the tincture are manufactured. From one weight part of herbal substance containing alkaloids and cardiac glycosides, 10 volume parts of tincture are manufactured, unless otherwise specified in the monograph or regulatory documentation.
After completion of the extraction process, tinctures are set at a temperature of no higher than 8-10 °C for at least 2 days until a clear liquid is obtained and then filtered. In the process of storing a number of tinctures, mainly complex ones, the formation of an insignificant sediment of ballast substances is allowed, provided that there are no biologically active substances by which standardization is carried out.
Tinctures can be used as medicinal herbal products for internal or external use or be part of other medicinal products, for example, elixirs, oral drops, etc.
Description. Tinctures should comply in appearance and odor with the requirements of the monograph or regulatory documentation.
Density. The determination is carried out, if specified in the monograph or regulatory documentation, in accordance with the GM «Density». The density value should correspond to the limits specified in the monograph or regulatory documentation.
Ethyl alcohol. The test is carried out in accordance with the GM «Determination of ethyl alcohol in liquid pharmaceutical products», unless otherwise specified in the monograph or regulatory documentation. The value of the ethyl alcohol content should be given as percentage and correspond to the limits specified in the monograph or regulatory documentation.
Methanol and 2-propanol. In tinctures, the content of not more than 0.05% of methanol and not more than 0.05% of 2-propanol is allowed, unless otherwise specified in the monograph or regulatory documentation. The determination is carried out by gas chromatography in accordance with the GM «Residual organic solvents».
Dry residue. 5.0 ml of tincture is placed in a previously dried at a temperature of 100 — 105°C to a constant weight and precisely weighed porcelain cup with a diameter of 5 cm or a weighing cup weighed to the nearest 0.0001 g, evaporated in a water bath to dryness, dried in an oven for 2 hours at a temperature of (102.5 ± 2.5) °C, cooled in a desiccator (over anhydrous silica gel, calcium chloride anhydrous or other suitable desiccant) for 30 minutes and weighed. The result is expressed as percentage. Dry residue amount should correspond to the limits specified in the monograph or regulatory documentation.
Heavy metals. 10 ml of tincture is evaporated in a porcelain cup to dryness in a water bath, 1 ml of concentrated sulfuric acid is added, carefully burned and calcined at a temperature of 600 °C. Add 5 ml of a saturated solution of ammonium acetate to the obtained residue under heating, filter through an ash-free filter, wash with 5 ml of water and bring the filtrate is brought to 100 ml with water; 10 ml of the obtained solution should withstand tests for heavy metals (the GM «Heavy metals», method 1). The permissible content of heavy metals should not be more than 2.5%.
Package content volume. The determination is carried out in accordance with the GM «Weight (volume) of the package contents».
Assay. The content of biological active ingredients or biological activity is determined using validated procedures and expressed as percentage or U/ml.
In accordance with the requirements of the GM «Dosage forms», in vials of orange glass.
In accordance with the requirements of the GM «Dosage forms». The label states the amount of starting material in grams and the amount of ethyl alcohol of specified concentration sufficient to produce 1 L of tincture.
In accordance with the requirements of the GM «Storage of medicinal products». It is stored in a dark place at a temperature of 15 to 25 °С, unless otherwise specified in the monograph or regulatory documentation.