Gel inspection method

The quality requirements of the gelling agent: it should be uniform, fine and gel-like at room temperature, without drying up or liquefying.

(1) Granularity inspection

1.

2.

(1) Calibration of the eyepiece micrometer: calibrate according to the microscopic identification method (General Rules 2001)

(2) Measurement method: Check according to the particle size and particle size distribution measurement method (General Rule 0982 First Method Microscope Method)

(3) Suspension type gel: Take an appropriate amount of the test product, place it on the glass slide, and apply a thin layer.

3.

(1) When sampling directly, the sampling amount should be appropriate (about 0.

(2) For particles with irregular shapes, the maximum value is the size of the particle during measurement

4.

(1) Among the 3 smears examined under the microscope, if the number of particles larger than 180um is not detected, it is judged to meet the requirements

(2) If the number of particles larger than 180um is detected, it will be judged as non-compliance

5.

(1) Record the microscope model and the number of smears

(2) Record the number of particles larger than 180 in the mirror

(2) Checking the quantity

1.

2.
The operation method shall be operated in accordance with the minimum loading inspection method (general rule 0942 weight method or volume method)
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3.
The precautions are the same as the minimum loading inspection method
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4.
Results and Judgment

(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
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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 are calculated according to the label filling quantity to calculate the percentage of the label filling quantity, and the result shall be judged with three significant figures
.

5.
Records and calculations are the same as the minimum loading inspection method
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(3) Sterility inspection

Unless otherwise specified, the gel used for burns or severe wounds shall be inspected according to the sterility inspection method (General Principle 1101) and shall meet the requirements
.

(4) Microbial limit inspection

Unless otherwise specified, the gel shall be inspected for the microbial limit of 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.

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Related link: Inspection method of aerosol (2)