Nonclinical Services

Characterization study of test substance and determination of test substance in formulations

Various safety studies, pharmacological studies, pharmacokinetic studies, etc. are conducted at LSIM Safety Institute. It is necessary to confirm the characteristics and stability of the test substance used for these GLP studies. The test substance concentrations in the formulations administered to animals must also be confirmed exactly by instrumental analysis. To meet those requirements, we conduct HPLC and other analytical studies based on advanced techniques.

Our contract services

• 1.Determination of test substance concentration in dosing formulations
  (GLP compliant)

  Determination of the test substance concentration in dosing formulations required in GLP studies is conducted using HPLC, GC, LC-MS/MS, spectrophotometer, etc. In addition, analytical method validation is conducted prior to determination to assure the reliability of the analytical method.

• 2.Determination of test substance concentration in dietary formulations
  (GLP compliant)

  Determination of the test substance concentration in the dietary formulations required in GLP studies is conducted by HPLC, GC, LC-MS/MS, spectrophotometer, etc. In addition, analytical method validation is conducted prior to determination to assure the reliability of the analytical method.

• 3.Characterization study of test substance
  (GLP compliant)

  Characterization and stability study of the test substance required in the GLP studies are conducted. In addition, analytical method validation is conducted prior to quantitative analysis to assure the reliability of the analytical method.
  Test items of the characterization study are listed below.

  • -Description

  • -Identification (IR, UV, Electrophoresis, etc.)

  • -Characteristic value (pH)

  • -Purity (Related substance etc.: HPLC, GC)

  • -Assay (UV, HPLC, GC, ELISA, RIA, Biological activity etc.)

  • -Water content (KF)

• 4.Method development

  Method development (dosing formulation analysis, dietary formulation analysis, trace analysis of the formulation, etc.) is conducted to establish optimum analytical method based on advanced analysis techniques. Atypical methods are also welcome. Please do not hesitate to consult us about the above and other analysis techniques.