GMP Analytical Validation Support
The following packed columns are accompanied by a certificate that assures the performance of the packing agent.*1
[Particle size: 3 μm]
・Wakosil®-Ⅱ 3C18 HG, Wakosil®-Ⅱ 3C18 RS, Wakosil®-Ⅱ 3C18 AR
・Wakosil®-Ⅱ 3C8 RS
[Particle size: 5 μm]
・Wakosil®-Ⅱ 5C18 HG, Wakosil®-Ⅱ 5C18 RS, Wakosil®-Ⅱ 5C18 AR
・Wakosil®-Ⅱ 5C8 HG, Wakosil®-Ⅱ 5C8 RS
[Others]
Handy ODS
Our company has attached "Wakopak® Certificate of Analysis"*1, which assures reproducibility within the specifications by describing the <1> various physical properties of silica-gel-based materials themselves and <2> specification and measured values of the characteristics of various packing agents after modification as support for the analytical validation of the above 10 types of packing agents to Wakopak® Column Performance Report, whose quality has been assured by testing the packing state of each previously attached packed column unit.
Columns that support this validation include traditional columns with a certificate to assure the quality of the packing agent.
*1Excluding pre-column/guard column
Wakopak® Column Performance Report
Inspect the packing condition of each column to assure its quality.
- Number of theoretical plates (Naphthalene)
- Retention coefficient (Naphthalene)
- Separation factor (Naphthalene/Benzene)
- Symmetry of peak (Naphthalene), factor for tailing and symmetry (within 10% of peak height)
Wakopak® Certificate of Analysis
The performance and characteristics of the packing agent (raw material silica gel / modified silica gel) are evaluated for each lot under each analytical condition,*2 and the measured values and acceptance criteria are described.
*2The analytical items vary depending on the type of packing agent.
Raw material silica gel
- Particle size distribution
- Pore diameter, specific surface area, pore volume
- Loss on drying
ODS modified silica gel
- Carbon content
- Loss on drying
- Number of theoretical plates (Naphthalene)
- Retention coefficient (Naphthalene)
- Separation factor (Naphthalene/Benzene)
- Symmetry of peak (Naphthalene): factor for tailing and symmetry (within 10% of peak height)
- Separation factor (Pyridine/Phenol): degree of inactivity to basic compounds
- Symmetry factor (Procainamide/2,4,6-Trimethylpyridine) : degree of inactivity to basic compounds
- Retention time (Dopamine/DOPA): retention characteristics of polar substances
- Tailing factor (Oxine-Cu): degree of inactivity for metal coordination compounds
- Planar recognition ability (Triphenylene/Dibenz［a,h］anthracene)
For research use or further manufacturing use only. Not for use in diagnostic procedures.
Product content may differ from the actual image due to minor specification changes etc.
If the revision of product standards and packaging standards has been made, there is a case where the actual product specifications and images are different.