Contact Us
Chengguan District, Lanzhou, Gansu, China
© 2025 Jeifer Pharmaceutical, All Right
Reserved.
Sodium Sulfobutyl Betacyclodextrin BP EP USP Pharma Grade belongs to the family of modified cyclodextrins designed for use in the pharmaceutical field. Chemically, it features a beta-cyclodextrin core, which is a cycle formed by seven glucose units, with sulfobutyl ether groups attached to the molecule. This modification tailors the compound’s solubility and interaction with a variety of therapeutic agents. Its widespread use in medicine springs from the way its molecular structure improves solubility and bioavailability for drugs that usually struggle to dissolve in water. Hospitals and pharmaceutical labs rely on such compounds not just for convenience but for effectiveness in drug formulation and delivery.
The physical presentation of this substance can be seen as a white or slightly off-white solid powder, sometimes appearing as fine flakes or even as pearls, due to its method of manufacture or subsequent handling. Rarely, it might be found in a granular or crystalline form, but the most common experience involves a soft, almost silky powder that flows easily when poured. The structure sits as a doughnut-shaped ring, the way the glucose units loop around, forming a cavity that can encapsulate other molecules. Its density tends to float around 0.9 to 1.2 g/cm³, impacted by humidity and particle size. Under the microscope, the substance does not show the clear, geometric patterns seen in pure crystals like table salt, but there’s a loose, amorphous character which matches its easy dissolution in water. Handling this powder rarely creates dust, and it mixes smoothly into liquids, letting chemists create clear solutions at many concentrations. This makes it valuable for people working in labs who want consistency and predictability.
The molecular formula reads as C42H70-nO35(C4H8SO3Na)n. The ‘n’ refers to the degree of substitution, which can vary a bit depending on how the manufacturer adapts the product for a given use. This flexibility means that not every batch has the exact same count of sulfobutyl groups per cyclodextrin, yet all variants will perform similarly for their main jobs in drug solubilization. The average molecular weight ranges from about 2163 to 3340 g/mol. Those in formulation need to watch this measure because it affects dosing and regulatory compliance. Giving a full molecular picture gets complicated, but the main point is that these substituted cyclodextrins stay safe and stable for their intended uses.
Sodium Sulfobutyl Betacyclodextrin stands out for its safety, which finds support in pharmaceutical regulatory approvals. Tests show low toxicity both in the lab and in real-life medical settings. Handling the product rarely requires more than standard safety gear: gloves and a mask to keep the powder out of the nose and lungs, but no specialized precautions compared to many raw materials. Unlike volatile chemicals, this powder neither catches fire easily nor reacts with air or water, making it far from hazardous. The substance does not give off toxic fumes, nor does it corrode skin. Even so, safety data sheets remind lab staff to avoid ingestion outside of approved protocols and to wash hands after handling. The European Pharmacopoeia and United States Pharmacopeia have tested and certified these grades for drug formulation, further emphasizing that the product meets expectations for cleanliness and low risk.
Each batch of Sodium Sulfobutyl Betacyclodextrin BP EP USP Pharma Grade comes with a full set of specifications to meet established pharmacopoeial standards. Water content, identified by Karl Fischer titration, normally sits around 8–14%, which helps stabilize the powder and keeps it pourable. The particle size distribution often fits into a 40–80 mesh range, fine enough for uniform mixing and quick dissolution when added to solutions. Heavy metal testing assures trace contaminants stay far below harmful thresholds, usually under 10 parts per million. Residual solvent tests draw direct lines to safe handling practices during production. The specific rotation, a number describing how the compound twists polarized light, gives another fingerprint of purity, while the product’s HPLC chromatogram tells manufacturers if related substances are present. For anyone invested in quality pharmaceutical solutions, these precise data points map directly onto reliability and patient safety.
For international trade and shipping, the official Harmonized System (HS) Code appearing on paperwork is 29400090 for most regions. This code covers cyclodextrins and their derivatives, alerting customs officers and regulators to the product’s special status. Labs and pharma producers use this code on import documents to smooth out shipments through customs, sidestepping confusion or hold-ups. Registration under this code also signals compliance with safety and hazardous goods laws, since this class of chemical does not need classification as dangerous for transportation.
Producing Sodium Sulfobutyl Betacyclodextrin starts with cyclodextrin, which itself comes from enzymatic processing of starches like corn or potato. This positions the product in an eco-friendly raw material chain, since corn and potato crops renew annually. From there, manufacturers use sulfobutyl etherification to add the functional groups, keeping the production inside regulated local factories that care about purity and traceability. This manufacturing process yields a product that holds a critical place in the pharma toolbox for injectable solutions and oral tablets—both fields that bring countless lives improved health every year. A lot of practical work and institutional memory rides on the shoulders of anyone who specs or handles this material in real-world production.
Sodium Sulfobutyl Betacyclodextrin answers one of the most vexing problems in drug formulation: how to make water-hating active ingredients soluble enough to reach patient bloodstreams. With its ring-shaped molecular structure, it forms inclusion complexes that tuck away stubborn drug molecules, letting them stay stable in liquid solutions, finished tablets, or even freeze-dried products. This opens pathways for creating new injectable or oral medicines where drug candidates previously failed. Recent years show the material rising in use, not only for blockbuster pharmaceuticals but also in generics and hospital-prepared medicines. The flexibility and safety of these compounds keep them prominent when any new, challenging active ingredient hits the developmental pipeline. Labs, producers, and patients alike benefit from advances in purity, consistency, and chemical handling safety earned over decades of rigorous study and continuous improvement in the field.
Chengguan District, Lanzhou, Gansu, China
