MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION
Table of Contents
Supersedes the XI Monograph of the State Pharmacopoeia
Syrups are a liquid dosage form for oral administration, which is predominantly a concentrated solution of various sugars, containing the active ingredients and excipients.
Syrups are, as a rule, transparent viscous liquids of sweet taste. Depending on the composition and physicochemical properties of the active ingredients and excipients, they may be opalescent or heterogeneous dispersion systems (generally, suspensions), acquire characteristic color and odor.
To prevent the crystallization of the syrup-forming component and the correction of other parameters, glycerol, various polyalcohols, surface active substances and other excipients approved for oral administration may be added to syrups.
The requirements of this monograph also apply to syrups produced by dissolving powders and granules.
Syrups are produced by dissolving sugars or other syrup-forming substances (e.g., polyalcohols) in water when heated to boiling point. Normally the concentration of sugar or other syrup-forming substance in the finished syrup is not less than 45% (m/m). The finished syrup is filtered. Active ingredients, tinctures, extracts, preservatives, etc. are added after cooling the syrup to a temperature of (55 ± 5) °C.
In the composition of syrups, antimicrobial preservatives are usually added: ethyl alcohol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sorbic acid, potassium sorbate, sodium benzoate, etc.
Description. The description of syrup appearance is given with the indication of color and odor. Syrups, as a rule, should be transparent, opalescence is allowed, signs of crystallization of the syrup-forming component are not allowed.
Density. Testing is carried out by one of the methods described in the GM “Density”. Standards are specified in the monograph or regulatory documentation.
pH. It is determined if specified in the monograph or regulatory documentation. The determination is carried out by a potentiometric method in accordance with the GM “Ionometry”.
In accordance with the requirements of the GM “Dosage forms”. As a means for measuring a prescribed dose, a dosing spoon, a cup or a cap may be provided in the package.
In accordance with the requirements of the GM “Dosage forms”.
In accordance with the requirements of the GM “Storage of medicinal products”. In a package that provides stability during the indicated shelf life of the medicinal product, in a dark place at a temperature of 8 to 15 °C, unless otherwise specified in the monograph or regulatory documentation.