Inspection method of Chinese medicine spray (2)

(4) Inspection of uniformity of delivered dose

1.

2.

3.

(5) Dose inspection of fine particles

1.

2.

3.

(6) Delivery rate and total delivery check

1.

2.

3.

(7) Checking the difference in loading

1.

2.

(1) Unless otherwise specified, take 20 test products, and calculate the volume and average volume of each content according to the methods specified under each category

(2) Compare the quantity of each with the average quantity

3.

4.

(1) Comparing each load with the average load, according to Table 15-19, none of them exceed the limit of the difference of the load; or the limit of the difference of the load is not more than two, and none of them exceed the limit of the difference of the load 1 Times, all are judged to be in compliance with the regulations

(2) If there are more than two items exceeding the limit of the difference in loading, or if the limit is not more than two, but one exceeds the limit of the difference in loading by one time, it will be judged as non-compliance
.

Table 15-19 Inspection of the difference limit of single-dose spray

5.
Records and calculations

(1) Record the model of the analytical balance
.

(2) Record each weighing data
.

(3) Find the weight of each content
.

(4) According to the average filling quantity, find the allowable filling quantity range
.

(8) Checking the quantity

1.
Brief description This law is applicable to the inspection of non-quantitative sprays.
The purpose of this inspection is to ensure the accuracy of the dosage
.

2.
The method of operation is in accordance with the minimum loading inspection method (general rule 0942)
.

3.
The precautions are the same as the minimum loading inspection method
.

4.
Results and Judgment

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

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

(3) The average filling quantity and the filling quantity of each container (according to the percentage of the marked filling quantity), take three significant figures to judge the result
.

5.
Records and calculations are the same as the minimum loading inspection method
.

(9) Sterility inspection

Unless otherwise specified, inhalation sprays for nebulizers, metered inhalation sprays and sprays used for burns, severe wounds or clinically necessary sterility, shall be checked according to the sterility inspection method (general rule 1101) and shall meet the requirements
.

(10) Microbial limit inspection

Unless otherwise specified, sprays shall comply with the microbiological limit inspection method: microbial counting method (General Rule 1105) and control bacteria inspection (General Rule 1106) and the microbiological limit standard (General Rule 1107) of non-sterile drugs should meet the requirements
.