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Quasi Drugs

  • 확대
  • 축소
  • 인쇄

Quasi-drug

KOTITI offers quality management services for quasi-drugs based on standards and testing methods of each product, and also designs proper analytical methods for new product according to the permission and evaluation of the Korea MFDS. For some years ahead, KOTITI will expand its service area to quantitative analysis using various analytical instruments (HPLC, GC, AAS) and general tests such as microbial limit test specified in the Korean Pharmacopoeia.

Test Items

  • Quasi-drugs (Article 2, Section 7 of the Pharmaceutical Affairs Law)
    • In forms of liquid, semi-solid, aerosol, etc. (ex: mouthwash, anti-hair loss agent, toothpaste, contact lenses products, pesticide, rodenticide, disinfectant)

Main Tests

  • General Tests

    Confirmation test, Content test, pH measurement test, Alcohol number counting (the 2nd), Qualitative reaction, Capacity test, Pressure withstand test, Safety test, Microbial limitation test, Property test, Ignition loss test, Ignition residue test, Drying loss test, Metal filth test , Insoluble filth test, Mechanical analysis of the agent, Real capacity test, Gravity and density measurement test, etc.
  • Instrumental Analysis Tests

    HPLC, GC, AAS, UV-VIS, ICP-OES, etc.

Related Standards

  • Standards and Test Methods for Quasi-drugs (Korean Quasi-drug Codex, KQC)
  • Korean Pharmacopoeia, KP
  • US Pharmacopoeia(USP), In-house method
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