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Liniment
The quality requirements of liniment: Unless otherwise specified, the relative density and pH value should be checked if the solvent is water or dilute ethanol ; the amount of ethanol should be checked if the solvent is ethanol; the amount of ethanol should be checked if the solvent is oil, and there should be no rancidity or deterioration.
(1) Checking the quantity
1.
2.
3.
4.
(1) The filling and average filling of the contents of each container shall be in accordance with the minimum filling inspection method (gravity method or volumetric method), and the filling volume of each container shall not be less than the allowable minimum filling volume; and the average filling shall be If the quantity is not less than the marked quantity, it will be judged to meet the requirements
(2) If one container does not meet the requirements, take another 5 (3 for 50ml or more) for retest
(3) The average filling quantity and the filling quantity of each container (calculate the percentage according to the marked filling quantity), and take three significant figures to judge the result
5.
(2) Microbial limit inspection
Unless otherwise specified, the microbial limit inspection of the liniment according to the non-sterile products: the microbial counting method (General Rule 1105) and the control bacteria inspection (General Rule 1106) and the microbiological limit standard of non-sterile drugs (General Rule 1107) shall meet the requirements
Patch
The quality requirements of the patch: The appearance of the patch should be complete and clean, with a uniform application area, and the punching incision should be smooth without sharp edges
(1) Content uniformity inspection
The patch according to the content uniformity inspection method (General Rule 0941) shall be determined in accordance with the relevant regulations under each category
(2) Release inspection
The patch according to the dissolution test method (General Rules 0931 Fourth and Fifth Method) determination should comply with the relevant regulations under each category
(3) Microbial limit inspection
Unless otherwise specified, the microbial limit inspection of non-sterile products of the patch: the microbial counting method (General Rule 1105) and the control bacteria inspection (General Rule 1106) and the microbiological limit standard of non-sterile drugs (General Rule 1107) shall meet the requirements