Application (Appendix I T of Part II of the 2010 edition of the Chinese Pharmacopoeia) refers to liquid preparations containing a solution, emulsion or suspension of a drug in ethanol, oil or a suitable solvent for rubbing on unbroken skin. Spread (Appendix I T of Part II of the 2010 edition of the Chinese Pharmacopoeia) refers to aqueous or oily solutions, emulsions, or suspensions containing drugs for liquid preparations that are dipped in or applied to the skin or mucous membranes of the oral cavity and the throat with sterilized gauze or cotton balls prior to use. Film-forming agent (Appendix I T of the 2010 edition of the Chinese Pharmacopoeia, Part II) refers to liquid preparations for external use in which the drug is dissolved or dispersed in solvents containing film-forming materials, and a film is formed after application to the affected area. For the quality requirements of application, coating and film-forming agent, in addition to non-toxicity, no local irritation, no rancidity, no discoloration, as well as the test items stipulated in the Pharmacopoeia under the varieties, it should also be checked for "loading", "sterility" or "microbial limit". Microbiological limits".

Operation method

"Volume" checking method

Principle

Unless otherwise specified, this method is applicable to the loading inspection of applicators, coatings and film applicators.

Materials and Instruments

Applying agent Coating agent
Ethanol
measuring cylinder

Move

I. Methods of operation
Unless otherwise specified, inspection in accordance with the Standard Practice for Minimum Load Inspection Method shall be in accordance with the provisions.

Caveat

1. When opening the container, care should be taken to avoid loss; the mouth of the container should be clean and no foreign matter should be brought into the test solution.

2. Suspensions should be shaken well before loading and checking.

3. For applicators and coating agents containing ethanol, care should be taken to prevent errors caused by solvent evaporation during the checking.

4. When the coating agent is checked by weight method, the container should be washed and dried with suitable solvent, and then the weight of the empty container should be weighed precisely, and the order of numbering should be noted to avoid confusion.

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