Inspection method of coating agent

The quality requirements of the coating agent: unless otherwise specified, the coating agent should be stable.

(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) Sterility inspection

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

(3) Microbial limit inspection

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

Relevant tincture quality requirements: unless otherwise specified, each 100ml is equivalent to 20g of the original decoction piece

The tincture should be clarified, and a small amount of precipitation is allowed to disperse after long-term storage

(1) Check the amount of ethanol

1.

(1) This law is applicable to the inspection of the amount of ethanol in tinctures.

(2) The amount of ethanol can be checked by gas chromatography or distillation to determine the content of ethanol in the tincture

2.
The method of operation shall be carried out in accordance with the method under the method of ethanol content determination (General Principle 0711 Gas Chromatography or Distillation)
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3.
Matters needing attention

(1) In the chromatogram of the test solution containing no internal standard substance, no impurity peak should appear at the position corresponding to the peak of the internal standard substance
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(2) Unless otherwise specified, if the result of the distillation method is inconsistent with the gas chromatography method, the result of the gas chromatography method shall prevail
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(3) If the distillate of any method is turbid during the measurement by distillation method, add talc or calcium carbonate to shake, filter, make the solution clear, and then measure the relative density
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(4) If foam occurs during distillation , add sulfuric acid or phosphoric acid to the test product to make it strong acid, or add a little excess of calcium chloride solution, or add a small amount of paraffin before distillation
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4.
The result and judgment are in compliance with the regulations under each category, and it is judged to be in compliance
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5.
Records and calculations are the same as the determination of ethanol content
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(2) Check the amount of methanol

1.
Brief description

(1) This law is applicable to the inspection of the amount of methanol in tinctures.
The purpose of this inspection is to control the content of methanol to ensure the quality of the medicine
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(2) The amount of methanol is checked by gas chromatography
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2.
The operation method is in accordance with the first method (capillary column method) or the second method (packed column method) under the methanol content inspection method (general rule 0871)
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3.
Matters needing attention If the impurity peak appears at the corresponding position of the internal standard substance peak when the packed column method is used, the external standard method can be used instead
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4.
Results and Judgment Unless otherwise specified, if the methanol content of the test solution does not exceed 0.
05% (ml/ml), it is judged to meet the requirements
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5.
Records and calculations are the same as the methanol amount inspection method
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(3) Inspection of loading

1.
Briefly describe the application of this law to the inspection of tinctures
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The purpose of this inspection is to ensure the accuracy of the medication dosage
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2.
The operation method is in accordance with the minimum loading inspection method (general rule 0942 volume method)
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3.
Precautions 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
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4.
Results and Judgment

(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).
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.
In accordance with the marked quantity, it is judged to be in compliance with the regulations
.

(2) If one container does not meet the requirements, another 5 (3 for 50ml or more) shall be taken 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 (calculate the percentage according to the marked filling quantity), and take three significant figures to judge the result
.

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

(4) Microbial limit

Unless otherwise specified, tinctures 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
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