Tests for syrup preparations
Syrup (Appendix I K of Part II of the 2010 edition of the Chinese Pharmacopoeia) refers to a concentrated aqueous sucrose solution containing the drug for oral administration. The quality requirements for syrup, in addition to clarification, the amount of sucrose should not be less than 45% (g / ml), there should be no mold, rancidity, gas or other deterioration phenomena, as well as the Pharmacopoeia varieties of the test items provided for under the item, it should also check the "loading" and "microbial limit". In addition to the test items stipulated under the pharmacopoeia varieties, "loading" and "microbial limit" should be checked.
Operation method
"Volume" checking method
Principle
This method applies to the single-dose filling of the syrup filling check, the purpose is to ensure the accuracy of the dose of medicine. Multi-dose filling of syrup, according to the minimum loading inspection method of standard operating procedures, should be in line with the provisions.
Materials and Instruments
syrup solution Move I. Instruments and Appliances Caveat 1. The measuring cylinder must be clean, dry and regularly tested; its maximum scale value should be the same as the labeled volume of the test article, or not more than twice the labeled volume. 2. The syrup agent is generally viscous liquid, after pouring into the measuring cylinder, the test container should be inverted for 15 minutes, as far as possible to pour out. For more product details, please visit Aladdin Scientific website.
graduated measuring cylinder
Standardized manometric measuring cylinders.
II. Methods of operation
Take 5 test pieces, open them carefully, pour the contents separately into a standardized dry measuring cylinder (manometric), pour as much as possible, and read the charge of the contents of each container at room temperature (to three significant digits).
III. Records and calculations
Record the room temperature, the number of test pieces drawn, the labeled loading of the test piece, and the measured loading of each test piece.
IV. Results and determinations
Comparison of the quantity of each test piece with the labeled quantity, are equal to or greater than the labeled quantity; or less than the labeled quantity of not more than 1, and not less than 95% of the labeled quantity, are judged to be in compliance. Otherwise, it is non-compliant.