Bulk Silica Gel and Chromatography Media Osaka Soda / DAISOGEL
DAISOGEL high-purity spherical silica media engineered by Osaka Soda for analytical, preparative, and industrial scale liquid chromatography. Standard and wide pore phases for peptide and API separation.
Spherical Bare Silica DAISOGEL SP
DAISOGEL ultra-pure spherical silica gel manufactured by Osaka Soda provides high mechanical strength and narrow particle size distribution for preparative liquid chromatography. Fully porous matrix delivers minimal backpressure and straightforward scale-up to process columns.
- Totally spherical silica with pore diameters from 60 to 2000 angstroms
- Specific surface area up to 450 m2/g enabling elevated sample mass loading
- Trace heavy metal contaminants controlled below 10 ppm for Fe, Al, Ti, Zr
- Particle sizes spanning analytical 1.7 to 5 um and bulk 10 to 50 um media
Reversed-Phase Media DAISOGEL ODS C18
Reversed-phase DAISOGEL ODS bulk media offers high carbon load, reproducible selectivity, and US FDA Drug Master File DMF registration for active pharmaceutical ingredient purification. High-density C18 bonding enables robust peptide isolation and consistent lot-to-lot performance.
- Octadecylsilane bonded phase featuring carbon loading up to 19 percent
- Extended chemical stability over mobile phase pH range from 2 to 10
- Registered with US FDA Drug Master File under master filing DMF 23227
- Standard bulk packaging in sealed containers from 1 kg up to 25 kg drums
Peptide and Protein Media C8 and C4
DAISOGEL C8 and C4 media are specifically engineered for preparative isolation of hydrophobic proteins, insulin, and synthetic polypeptides. Shorter alkyl chains prevent irreversible retention of biomolecules while promoting rapid elution and elevated recovery in DAC columns.
- Octyl C8 bonded silica with active US FDA Drug Master File DMF 22317
- Butyl C4 bonded media supported by US FDA Drug Master File DMF 29201
- Wide pore architectures 200 and 300 angstroms optimizing mass transport
- Elevated product recovery rates without denaturing sensitive peptides
Wide-Pore Sorbents SWP and BIO Series
DAISOGEL SWP and BIO series with extended pore sizes up to 2000 angstroms are designed for downstream purification of high molecular weight biopharmaceuticals. The wide aperture architecture eliminates size exclusion hindrances and unlocks full internal surface area for macro targets.
- Wide pore 1000 and 2000 angstrom grades for vaccines and plasmid DNA
- BIO series surface chemistry suppressing non-specific sample binding
- Narrow pore size distribution creating sharp and symmetrical elution peaks
- Bulk preparative particle diameters 10 and 20 um for plant operations
Alkaline-Resistant Media DAISOGEL PK Series
DAISOGEL PK series media are engineered for industrial purification workflows requiring frequent alkaline Cleaning-in-Place procedures. Proprietary silica shielding prevents matrix dissolution during routine 0.1 M sodium hydroxide sanitation, multiplying stationary phase lifetime.
- Resistant to routine 0.1 M NaOH sanitizing washes without matrix degradation
- Facilitates complete removal of denatured proteins and endotoxin residues
- Maintains theoretical plate count and retention factor through CIP cycles
- Reduces overall stationary phase replacement frequency in bulk columns
Preparative Columns and Bulk Media for DAC
DAISOGEL bulk media and pre-packed preparative columns are tailored for high-pressure Dynamic Axial Compression systems. High mechanical particle strength eliminates granule fracturing under axial piston loading, securing uniform solvent flow and zero channeling during separations.
- Compatible with commercial DAC column hardware from 50 mm to 1000 mm ID
- Withstands dynamic axial piston compression pressures up to 100 bar
- Pre-packed preparative hardware available with lot qualification testing
- Supplied with slurry preparation guidelines and slurry packing protocols
Particle Diameter and Pore Dimension Selection for Preparative Scale
Selecting optimal particle diameter and pore dimension determines overall separation efficiency and column hydraulic resistance.
For preparative liquid chromatography, Osaka Soda supplies DAISOGEL bulk media ranging from 10 um to 50 um while preserving identical selectivity to analytical 3 um and 5 um sorbents.
Pores measuring 100 and 120 angstroms are recommended for small chemical entities and hydrophobic targets, providing specific surface area up to 450 square meters per gram.
Wide-pore matrices of 200 and 300 angstroms are tailored for peptide and protein purifications, avoiding diffusion restrictions inside microchannels. Very wide pores up to 2000 angstroms facilitate separation of macromolecules.
Sol-Gel Synthesis Architecture and Trace Metal Impurity Control
The spherical framework of DAISOGEL is synthesized at Japanese production sites in Amagasaki and Matsuyama through sol-gel silicic acid polymerization. This proprietary process prevents granule chipping, jagged fragments, and micro-fissures common in irregular silica particles.
Stringent analytical verification using ICP and XRF guarantees ultra-low heavy metal residues: concentrations of iron, aluminium, titanium, and zirconium remain below 10 ppm for each element.
This high purity suppresses secondary chelation of basic target molecules and prevents catalytic degradation of labile pharmaceutical substances upon contact with stationary media. High particle sphericity lowers backpressure during high-flow elution.
GMP Quality Assurance Guidelines and US FDA Drug Master Files
Production of base spherical silica is qualified under ISO 9001 quality management, while chemical modification and functional group bonding follow Good Manufacturing Practice protocols based on ICH Q7A guidelines.
For pharmaceutical corporations exporting finished drug substances and therapeutics, Osaka Soda delivers direct regulatory documentation.
Active Drug Master Files are maintained with the US FDA: DMF number 23227 covers the ODS series, DMF number 22317 covers the C8 portfolio, and DMF number 29201 supports the C4 bonded media.
Purchasing clients receive comprehensive certificates of analysis, validation methodologies, and regulatory audit support packages.
Dynamic Axial Compression DAC Column Compaction and Alkaline Sanitization
Industrial downstream purification requires elevated mechanical particle resilience during bed packing in Dynamic Axial Compression hardware. DAISOGEL spherical granules withstand repeated hydraulic piston compression cycles up to 100 bar without particle shattering or fine fragment generation.
During purification of recombinant peptides and insulin, packed beds undergo routine Clean-in-Place cycles. The specialized PK series features polymeric silica shielding capable of withstanding 0.1 M sodium hydroxide sanitizing solutions at ambient room temperatures.
This capability ensures complete removal of pyrogens and denatured proteins while maintaining theoretical plate numbers.
Method Scale-Up Architecture from Analytical HPLC to Plant Scale
An essential engineering advantage of Osaka Soda consists of complete chemical property continuity between analytical columns and multi-kilogram bulk silica lots.
Separation selectivity, retention factors, and hydrophobic balance remain identical when transferring chromatographic protocols from 3 um or 5 um particles to preparative fractions of 10 um, 15 um, or 20 um.
This property enables process chemists to optimize elution gradients and mobile phase systems on standard HPLC equipment using minimal solvent volumes.
Developed protocols transfer directly onto high-pressure preparative process modules without retention factor recalculations, safeguarding resolution and pure recovery.
Technical Media Selection via TDS and SDS Verification Guidelines
Technical selection of DAISOGEL chromatography media is performed against technical data sheets and safety specifications to calculate bed volumes and bulk batch volumes.
Engineering specialists assess physical and chemical properties including bulk tap density, particle size distribution profiles, specific pore volume, and bonded carbon loading percentages.
For developing manufacturing pipelines, sample qualification lots ranging from 100 grams to multiple kilograms are supplied for pilot factory validation trials.
Shipments arrive with lot-specific chromatographic inspection documentation confirming purity and compliance under temperature-regulated shipping containers.
Osaka Soda / DAISOGEL and model names are trademarks of their respective owners and are used only to identify the equipment for which we source parts. SpareX is not an official dealer, distributor or representative of Osaka Soda / DAISOGEL and is not affiliated with the trademark owner. Origin, documents and warranty are stated for each item in the quotation.
