Technical Notes: Tips
Your knowledgebase for DAISOGEL silica gel products
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Are DAISOGEL Products Registered in FDA DMF?
Read More >According to the US FDA, “drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.” There are several types of DMFs. Type II DMFs are applied to “Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product.” The top-selling DAISOGEL phases have Type II FDA DMF registration. Our rigid manufacturing standards guarantee that only the highest quality silica gel products are delivered to our valued customers. We have FDA DMF registration for the following phases:
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What is the pH Range of DAISOGEL C8 and ODS Phases?
Read More >Are you purifying a compound that requires a very low pH condition for solubility or elution purposes? Perhaps you need a silica gel that can withstand caustic cleaning instead. The pH stability of a C8 or ODS silica gel is dependent on the robustness of the bare silica gel, as well as the ligand density and the quality of the bonding. DAISOGEL offers a wide range of bonded phases with various ligand densities to give you choices for finding the right match for your application. Your guide to the pH range of our most common C8 and ODS phases: Contact
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What is the Role of Ligand Density for Separation?
Read More >When meeting with potential bulk silica customers for the first time, we are often asked the following question: “Do you have an ODS/C18 phase?” While the answer is, of course, a resounding yes, we also suggest that this is not the right question to be asking your silica gel supplier! The right question is: “What different ligand densities do you offer for your ODS/C18 phases?” With ligand density (sometimes called bonding density), we express how much of the given ligand is grafted onto the silica’s surface – not only onto the outer particle surface, but also on the INSIDE of
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Seven Differentiators of DAISOGEL
Read More >There are many suppliers from around the world that offer bulk silica gel for chromatography. This plethora of supply gives you choices…and choices are a good thing for the chromatographer. So what is it that makes DAISOGEL different? What sets DAISOGEL apart from the other bulk silica gels on the market? Manufacturing your API is cash-intensive, and no doubt your management must carefully monitor the cash flow of the business. Contact us to learn more Reach out to see how DAISOGEL can help you sustain your mission-critical purification process.
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Column Regeneration Suggestions
Read More >Even well-packed columns will lose some of their efficiency over long usage periods of many cycles, especially when used with samples of high impurity level. If your column is used for synthetic peptide or recombinant peptide purification, or, in a worst-case, for aggregating, fibrillating peptide purification, the column performance can decrease rather quickly. The first warning sign is usually the rising backpressure of the column. Peak shape deterioration or the drop in the number of theoretical plates may be another sign that you need to clean off the fibrillated peptide building up on the inlet side of the silica bed
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Considerations for Performing Cleaning-in-Place (CIP)
Read More >Manufacturing managers in charge of the downstream processing plant for synthetic or recombinant peptides know very well that CIP of a packed chromatography column is a “necessary evil” to extend the lifetime of the bed. While CIP is a step that one may want to avoid as much as possible, it is also an economically important practice that can reduce the cost of manufacturing your API. Considerations for performing CIP on columns packed with a bonded phase silica gel The first and primary consideration is the CIP agent–what chemical to use. Of course, a milder chemical with pH closer to
