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Hydroxypropyl β-Cyclodextrin BP EP USP Pharma Grade stands as a modified cyclodextrin gaining solid traction in the pharmaceutical world because it solves one of the more frustrating challenges: boosting the solubility and bioavailability of drugs that otherwise resist dissolving in water. Structurally, its molecular formula is C42H70O35(C3H7O)n, which signifies a β-cyclodextrin core with hydroxypropyl groups replacing some of the hydrogen atoms. This tweak brings a noticeable improvement to how the substance handles solubility and interaction with other compounds. Its CAS number, a crucial marker in the world of chemicals, is 128446-35-5, offering traceability and assurance for buyers and regulators. Users in the pharma industry see clear value, especially with the tight BP, EP, and USP grade specifications that guarantee high purity and consistency.
Hydroxypropyl β-Cyclodextrin comes as a nearly white or slightly off-white powder. The touch test gives away its fine, free-flowing nature, feeling soft and easy to handle—very different from bulky crystals or sticky liquids. Some batches offer fine flakes or granule-like pearls, adding to handling flexibility in manufacturing. The density sits close to 1.4 g/cm³, making it easy to measure and mix in formulation labs where every milligram counts. It dissolves well in water, producing clear solutions even at higher concentrations—an uncommon trait among excipients of this class. Seldom does it clump or show insoluble residue, a fact that excites formulators keen on maximizing active ingredient absorption. What sets it apart is its stability and endurance against light and moderate heat, reducing loss during storage and processing. No characteristic odor comes off—an advantage for products where scent control impacts the end-user experience.
The backbone of Hydroxypropyl β-Cyclodextrin reveals a circular arrangement of seven glucose units joined at the 1,4-carbon bonds, and these form a sort of basket or ring. This cavity traps hydrophobic drug molecules, making them invisible to water, which forces the whole complex to dissolve. The addition of hydroxypropyl groups to the traditional β-cyclodextrin structure not only enhances this ability but also keeps the molecule from aggregating with itself, solving the clumping and precipitation issues present with plain cyclodextrin. The result is a crystal-clear inclusion complex that shields drugs from degradation and drives improved release rates in the body. Molecular interactions in this setup create a unique environment—one where water-hating drugs thrive in water-based systems, providing real promise for drug delivery.
Manufacturers stick to strict parameters. Loss on drying usually sits at less than 10%, and the hydroxypropoxy content ranges from 4.5% to 7.5%. The degree of substitution, indicating average hydroxypropyl group addition, generally falls between 0.6 and 1.0 per glucose unit. Clarity of solution, pH between 5.0 and 8.0 for a 1% aqueous solution, and near-zero heavy metal content satisfy most compendial requirements. Residual solvents get monitored closely—no one needs unwanted chemicals sneaking into medicines. Ash content, an index of non-organic residue, stays under strict control to support both regulatory needs and predictable behavior in production environments. Sodium and chloride content rarely go above microgram-per-gram thresholds, offering peace of mind for quality-control professionals. Testing for microbial limits confirms batch safety, especially for parenteral uses.
For global trade and cross-border shipping, Hydroxypropyl β-Cyclodextrin takes the HS Code 3505.10, which covers dextrins and other modified starches. Customs teams use this code for import/export paperwork, tariff calculation, and compliance assurance. The raw materials include pure β-cyclodextrin (often from enzymatic starch conversion) and propylene oxide, which provides the hydroxypropyl group during synthesis. Stringent material origins and traceable production chains guarantee pharmaceutical quality while supporting GMP certification efforts and regulatory filings around the world.
Availability comes in several textures—most commonly, powder and flakes, but also as coarser pearls and, in research settings, as crystalline forms. Handling the solid feels straightforward, with low dust generation if handled with right protective gear and engineering controls in place. It stores best in airtight containers within a dry, cool warehouse since exposure to high humidity or direct sunlight risks minor caking or degradation over long periods. Some specialty suppliers provide ready-made aqueous solutions, keeping concentration around 50% w/v, where clarity and viscosity matter in high-speed dosing or process lines.
Measured density reads slightly heavier than water, making it possible to prepare stock solutions without thickening into gels. It takes hold well in water—completely dissolving at moderate temperatures and low agitation rates. This avoids delays and batch variability in manufacturing. Viscosity properties depend on concentration, but usually, it slides along with minimal effect on flow rates or mixing pumps, allowing it to work with high-throughput systems common in tablet or injectable drug manufacturing. This solubility aids with accurate dosing and reliable ingredient dispersion in finished products.
Regulators consider Hydroxypropyl β-Cyclodextrin nontoxic when used as directed. The oral LD50 value in animal studies trends high, indicating low acute toxicity. Allergic reactions turn up very rarely, and the compound resists breakdown into harmful byproducts even under high-heat conditions in tableting machines or autoclaves. Spills, if they occur, do not trigger major concerns—routine cleanup keeps production environments hazard-free. Still, standard chemical safety practices apply: gloves, goggles, and dust masks reduce the low but present risk of respiratory irritation or skin dryness from direct contact. Waste generated filters out easily because the substance breaks down under mild chemical or biological treatment, supporting sustainability efforts in pharma manufacturing. Workers and end-users benefit from these safety margins, which enable broader use in sensitive drug delivery systems, including for pediatrics and immunocompromised adults.
Hydroxypropyl β-Cyclodextrin shines in real-world pharmaceutical scenarios. From turning an insoluble compound into an oral tablet to protecting volatile actives in liquids, its role broadens the toolbox for pharmacists and formulators. As more drugs in the pipeline show poor water solubility, demand for such cyclodextrins climbs. Addressing persistent manufacturing issues like inconsistent batch release rates or stability failures, Hydroxypropyl β-Cyclodextrin gives a reliable option that keeps excipient portfolios up to date. Expansion into food, veterinary, and cosmetic uses follows from these certified pharma grades, raising questions about cross-sector contamination, safety standards, and sustainable sourcing. Addressing those requires constant investment in traceability, quality assurance, and transparent supplier partnerships—topics close to home for anyone involved in regulated manufacturing or regulatory compliance.
Chengguan District, Lanzhou, Gansu, China
