Inspection method of lotion, mixture, lozenge

lotion

The quality requirements of the lotion: Unless otherwise specified, the pH value of the lotion with water or dilute ethanol as the solvent should be checked, and the amount of ethanol should be checked for the lotion containing ethanol

(1) Checking the quantity

1.

2.

3.

4.

(1) The filling quantity and average filling quantity of the contents of each container shall be in accordance with the minimum filling quantity inspection method (volume method).

(2) If one container does not meet the requirements, another 5 (3 for 50ml or more) shall be taken 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

Unless otherwise specified, the lotion shall be inspected according to the microbial limit of non-sterile products: the microbial enumeration method (General Rule 1105) and the inspection of controlled bacteria (General Rule 1106) and the microbiological limit standard of non-sterile drugs (General Rule 1107) shall meet the requirements

mixture

The quality requirements of the mixture: it should be clarified that there should be no mold, rancidity, foreign matter, discoloration, gas generation or other deterioration during storage, and a small amount of easily scattered precipitation is allowed

(1) Checking the quantity

1.

2.

(1) Single-dose filling mixture: Take 5 test samples, open them carefully to avoid spills, pour the contents into standardized and dried measuring cylinders, inspect at room temperature, and read out the contents of each test sample.

(2) Multi-dose filling mixture: operate in accordance with the minimum filling quantity inspection method (general rule 0942 volume method)

Take 5 test samples (take 3 samples if the marked capacity is more than 50ml).

3.
Matters needing attention

(1) The graduated cylinder used should be clean, dry, and calibrated regularly; its maximum capacity should be consistent with the labelled volume of the test product, or no more than twice the labelled volume
.

(2) If the test product is a viscous liquid, after pouring the contents into the graduated cylinder, the container should be inverted for 15 minutes to make it as full as possible, and then read the amount of each contents
.

4.
Results and Judgment

(1) Single-dose filling mixture: Comparing each test product with the labeling volume, if the test product volume is less than the labeling volume and not more than 1 bottle, and not less than 95% of the labeling volume, it is judged to be in compliance with the regulations.
; Otherwise, it is not in compliance with the regulations
.

(2) Multi-dose filling mixture

1) The filling quantity and average filling quantity of the contents of each container, according to the minimum filling quantity inspection method (volume method), the filling quantity of each container is not less than the minimum allowable filling quantity; and the average filling quantity is not less than The marked loading quantity is judged to be in compliance with the regulations
.

2) If one container does not meet the requirements, take another 5 (3 for more than 50ml) for retest
.
All the results of the retest meet the requirements, but they can still be judged as in compliance
.

3) The average volume and the volume of each container (calculate the percentage based on the marked volume, and take three significant figures to judge the result)
.

5.
Records and calculations

(1) recording temperature, means for marking the number and amount of test sample, the measured amount of loading of each container contents
.

(2) Divide the total volume of each container by 5 (or 3) to get the average volume
.

(3) Calculate the volume and average volume of the contents of each container
.
Calculate the minimum amount allowed
.

(2) Microbial limit inspection

Unless otherwise specified, the microbial limit inspection for non-sterile products of the mixture: the microbial enumeration method (General Rule 1105), the control bacteria inspection (General Rule 1106) and the microbiological limit standard of non-sterile drugs (General Rule 1107) shall meet the requirements
.

Lozenge

The quality requirements of the lozenges should be flat and smooth, consistent in color, free of shrinkage, flash, cracks, deformation and hollowness.
In addition to the inspection items specified under each variety, the weight difference and microbial limit should also be checked
.

(1) Weight difference check

Unless otherwise specified, the inspection method under the "weight difference" item of the pill shall be operated in accordance with the regulations
.

(2) Microbial limit inspection

Unless otherwise specified, the microbiological limit inspection of non-sterile products for tablets: microbial counting method (General Rule 1105) and control bacteria inspection (General Rule 1106) and non-sterile drug microbiological limit standard (General Rule 1107) inspection shall meet the requirements
.

Related link: Inspection method for liniment and patch