Biotech products＿Quality test
Contract services
We offer contract services for GMP quality testing.
Microbial tests
| Test item | Test method (table corresponding to Japanese Pharmacopoeia [JP18]) |
|---|---|
| Bacterial endotoxins test | General Tests - Bacterial Endotoxins Test <4.01> |
| Microbial limit (viable bacteria count) test | General Tests - Microbiological Examination of Non-sterile Products <4.05> |
| Sterility test | General Tests - Sterility Test <4.06> (technique of direct inoculation) (technique of membrane filtration) |
| Mycoplasma test | (A. Culture method) JP General Information G3 (G3-14-170) Mycoplasma Testing for Cell Substrates used for the Production of Biotechnological/Biological Products |
Protein assay
| Test item | Test method |
|---|---|
| Purity test | General Tests - Size-Exclusion Chromatography <2.05> SDS-Polyacrylamide Gel Electrophoresis - JP General Information G3 (G3-8-170) Isoelectric Focusing - JP General Information G3 (G3-6-142) |
| DNA content | Threshold method |
| Protein quantification | General Tests - Liquid Chromatography <2.01> Enzyme-linked Immunosorbent Assay (ELISA) - JP General Information G3 (G3-11-171) Protein quantification (UV absorption) - JP General Information G3 (G3-12-172) Bicinchoninic acid assay (BCA assay) |
| Potency | Biological activity test (in vitro) |
We perform various tests, including identification, quantitative, and purity tests, as part of our contract testing services. We also offer additional contract testing services such as the specification test according to the compendial method, quality testing based on the manufacturing approval, stability testing, and testing for water/pharmaceutical water used in studies of pharmaceutical products. Please contact us for more information.
Tests for injectable drugs
| Test item | Test method (Japanese Pharmacopoeia) |
|---|---|
| Uniformity of dosage units | General Tests - Uniformity of Dosage Units <6.02> |
| Extractable volume | General Tests - Test for Extractable Volume of Parenteral Preparations <6.05> |
| Foreign insoluble matters | General Tests - Foreign Insoluble Matter Test for Injections <6.06> |
| Insoluble particulate matters | General Tests - Insoluble Particulate Matter Test for Injections <6.07> |
| General Tests - Insoluble Particulate Matter Test for Therapeutic Protein Injections <6.17> |
Physicochemical tests
| Test item | Test method (Japanese Pharmacopoeia) |
|---|---|
| Viscosity | General Tests - Viscosity Determination <2.53> |
| Quantification/purity | General Tests - Liquid Chromatography <2.01> General Tests - Ultraviolet-visible Spectrophotometry <2.24> |
| Infrared absorption | General Tests - Infrared Spectrophotometry <2.25> |
| Water content | General Tests - Water Determination <2.48> |
| Loss on drying | General Tests - Loss on Drying Test <2.41> |
| Residue on ignition | General Tests - Residue on Ignition Test <2.44> |
| Test for total organic carbon | General Tests - Test for Total Organic Carbon <2.59> |
| Particle size | Measurement of the Diameter of Particles Dispersed in Liquid by Dynamic Light Scattering JP General Information G2 (G2-4-161) |
We perform various compendial tests, including the active pharmaceutical ingredient/formulation specification test, process control test, auxiliary material acceptance test, packaging material acceptance test, and water test.
We can also perform other tests such as pH determination, test for total organic carbon, conductivity measurement, osmolarity determination, and heavy metals limit test. These test are just examples. Please contact us for more information.
