KOTITI is a testing and inspection agency for pharmaceuticals and quasi-drugs, designated by the Ministry of Food and Drug Safety (MFDS) in accordance with the Pharmaceutical Affairs Act and related regulations.

Based on Good Manufacturing Practice (GMP) for pharmaceuticals and standards/specifications for quasi-drugs, the institute conducts various quality and safety evaluations, including physicochemical tests and microbial limit tests for raw materials and finished products. We provide specialized testing services to ensure the quality of pharmaceuticals and quasi-drugs, as well as to enhance product safety and regulatory compliance.

Target Products

  • Pharmaceuticals (e.g., Oral solid dosage forms, semi-solid dosage forms, other solid forms, liquid formulations)
  • Quasi-drugs (e.g., Health masks, toothpaste, sanitary pads, bandages, hand sanitizers)
  • Active Pharmaceutical Ingredients (APIs), excipients, etc.

Test & Inspection Items

  • Korean Pharmacopoeia (KP)
  • Standards and test methods for quasi-drugs (KQC)
  • Guidelines for health mask standards and test methods
  • Test method validation and verification
  • Stability test
  • Antiviral activity test
  • Other
    • 24 metal impurities (KP, USP, ICH Q3D Guidelines)
    • Genotoxic impurities (from main ingredients)
    • Microbial limit tests (KP, USP 60, USP 61, USP 62)
    • International standards (USP/NF, EP, JP, etc.)

Application Procedure

  • 01

    Testing Request

  • 02

    Application Processed

  • 03

    Issuance Quotation and Tax Invoice

  • 04

    Testing & Analysis

  • 05

    Payment of Fees

  • 06

    Issuance of Test Report

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