Inspection method for ophthalmic preparations (2)

3.

(1) Squeeze the ophthalmic semi-solid preparations into flat-bottomed petri dishes and warm them at 85°C to observe whether they have completely melted, otherwise the metallic foreign body cannot sink to the bottom of the dish, which affects counting and judgment

(2) The brightness of the incident light of the spotlight should be adjusted appropriately so that the metallic foreign objects can be clearly displayed

4.

(1) If it exceeds, another 20 retests should be taken; the results of the initial test and retest are combined, and the number of metallic foreign objects in each container of 30 is not more than 3, and the total number does not exceed 150.

(2) When the number of metallic foreign bodies in each of the 10 containers in the initial test exceeds 8 particles is more than 1, or the total number exceeds 50 particles; or in the initial test and retest 30, if each contains the number of metallic foreign bodies If there are more than 8 tablets or more than 3 tablets, or the total number of tablets exceeds 150 tablets, they are all judged as non-compliance

5.

(1) Record the microscope model, the number of inspections, the number of metallic foreign bodies in each, and calculate the total number of metallic foreign bodies in 10 containers

(2) If the initial test does not meet the requirements, record the retest results, and combine the results of the initial test and retest according to the regulations

(5) Checking the difference in loading

1.

2.

3.

4.

(1) Take 20 test products, if the quantity exceeds ±10% of the average, if it does not exceed 2, and does not exceed ±20% of the average quantity, it is judged as conforming to the regulations

(2) Take 20 test samples, if the quantity exceeds the average load by ±10%, if there are more than 2, and if the quantity exceeds the average load by ±20%, it will be judged as non-compliance

5.

(1) Record the model of the analytical balance
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(2) Record each weighing data
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(3) Find the weight of each content
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(4) According to the average filling quantity, find the allowable filling quantity range
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(6) Checking the quantity

1.
Brief description This law is applicable to the inspection of the volume of ophthalmic preparations.
The purpose of this inspection is to ensure the accuracy of the dosage
.

2.
Method of operation

(1) Single-dose packaged ophthalmic preparations: Take 10 test samples, pour the contents into standardized measuring cylinders (or suitable containers), and inspect, each filling quantity is the same as the label filling quantity.
The comparison shall not be less than the marked amount
.

(2) Multi-dose packaged ophthalmic preparations: operate in accordance with the minimum filling quantity inspection method (General Rule 0942)
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3.
Precautions The multi-dose packaged ophthalmic preparations are the same as the minimum filling inspection method
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4.
Results and Judgment

(1) Single-dose packaged ophthalmic preparations

1) Take 10 test products, and compare each package with the labelled volume, and all of them are not less than the labelled volume, and it is judged to be in compliance with the regulations
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2) Take 10 test samples, and compare each loaded volume with the labeled volume.
If one or more of them is less than the labeled volume, it will be judged as non-compliant
.

(2) Multi-dose packaged ophthalmic preparations

1) The volume and average volume of the contents of each container shall be in accordance with the minimum volume inspection method (gravity method or volume method), and the volume of each container shall not be less than the minimum allowable volume; and the average volume shall Not less than the marked loading quantity, it is judged as conforming to the regulations
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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
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3) The average filling quantity and the filling quantity of each container calculate the percentage of the label filling volume according to the label filling volume, and the result shall be judged with three significant figures
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5.
The recording and calculation of multi-dose packaged ophthalmic preparations is the same as the minimum filling inspection method
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(7) Check the osmolality

Unless otherwise specified, the aqueous solution eye drops shall comply with the regulations in accordance with the osmolarity determination method (General Rule 0942) in accordance with the regulations under each category
.

(8) Sterility inspection

Unless otherwise specified, ophthalmic preparations shall be inspected according to the sterility inspection method (General Principle 1101) and shall meet the requirements
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Related link: Inspection method for ophthalmic preparations (1)