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Glycocholic Acid BP EP USP Pharma Grade: Properties, Structure, and Material Profile

What is Glycocholic Acid BP EP USP Pharma Grade?

Glycocholic Acid BP EP USP Pharma Grade stands out as a critical bile acid derivative manufactured to meet strict international pharmacopeia standards. These standards ensure high purity and consistent quality, which both researchers and pharmaceutical producers rely on. In a laboratory or manufacturing plant, glycocholic acid often turns up in studies on lipid digestion, formulations of liver therapies, and investigations into metabolic function. Its origins date back to the observation and isolation of bile components, leading to glycocholic acid becoming a reference for both the analytical and the pharmaceutical world.

Structure and Molecular Details

Structured as an amide formed from cholic acid and glycine, glycocholic acid’s molecular formula reads C26H43NO6, with a molecular weight hovering around 465.6 g/mol. The presence of steroid backbone and functional groups influences its behavior in biological systems, granting it roles in micelle formation for fat emulsification. Structural analysis reveals white, crystalline material, although in various preparations I’ve handled samples that also manifest as fine powders or translucent flakes. Glycocholic acid holds a melting point near 135°C, showcasing its stability during moderate heating. Its solubility veers toward aqueous and ethanol solutions, which aids in practical handling for both lab-scale and industrial uses. This chemical substance aligns under the Harmonized System (HS) Code 293299, which assigns it to organic compounds with pharmaceutical applications.

Physical Properties and Appearance

This raw material typically appears as white or slightly off-white solid, sometimes offered in powder, crystalline, or flake form, depending on the production process and downstream application. Density hovers at around 1.26 g/cm³, not straying far from values typical for steroid derivatives. In my experience, the tactile nature of glycocholic acid points to a solid material with mild hygroscopic tendencies, prompting careful storage. Its powder and flake forms remain free-flowing when kept dry, which makes it easy to weigh out and blend for formulation work. Expect a neutral odor and a taste profile that’s strictly scientific—the kind you want to keep away from curious hands and mouths in any lab.

Specification and Safety Considerations

The specifications attached to glycocholic acid in the BP EP USP pharma grade context demand high purity, usually above 98%, with tight control on related impurities and moisture. Every batch comes with a clear certificate of analysis, reflecting limits for heavy metals, microbial content, and residual solvents. Material identification via IR, HPLC, or NMR confirms the profile. Handling the dry solid requires standard chemical safety gear: gloves, dust mask if airborne, and protective eyewear. Any worker in chemical supply or compounding environments likely learned that airborne dust can irritate the respiratory tract, so engineering controls help reduce exposure. Spills should be cleaned up with minimal dust creation, and disposal routes should move through chemical waste streams familiar to anyone working with hazardous, non-volatile organics. Incidents remain rare if the correct protocols anchor daily practice.

Applications in Pharma and Research

Pharmaceutical labs use glycocholic acid to investigate bile salt behavior in drug delivery and how these compounds enhance the solubility of poorly water-soluble actives. In the few projects I’ve joined where glycocholic acid comes in, formulation scientists pivot on its amphipathic properties to modify absorption kinetics in experimental therapies. Beyond drug formulation, glycocholic acid plays a diagnostic role, acting as a marker in tests evaluating cholesterol metabolism and liver function. The substance also serves as a reference standard during the development and validation of analytical assays. As a raw material, its stability and chemical profile make it a reliable input whether your process scales up to tonnage or operates at milligram quantities for pilot research.

Handling and Storage—Material and Safety Concerns

Glycocholic acid stores easily in tightly closed containers, kept cool and away from direct light, as per any organic chemical that must avoid hydrolysis and slow oxidation. Dry solids resist environmental changes if proper humidity controls hold steady, which can be tricky in regions with seasonal moisture swings. In solid, flake, or powdered forms, transfer under fume hoods offers peace of mind. Liquid solutions, less common at point of sale, may require dilution in buffered aqueous or mixed solvent systems. Emergency protocols for glycocholic acid incidents mirror those for mid-risk chemicals, where main worries include eye contact, inhalation, or skin exposure. Material safety data sheets dive deep into toxicological profiles and first-aid routines, presenting a complete narrative for lab safety officers and end-users alike.

Quality Controls and Regulatory Standards

Pharma grade glycocholic acid cannot forgo rigorous testing, which flows from globally harmonized monographs into national regulatory frameworks. No manufacturer can skip elemental impurity testing or microbial analysis, since oversight bodies demand clear evidence of product consistency. Storage and shipment receive equal scrutiny: sealed containers, packaging resistant to breakage, and documentation, including HS code tagging for customs routing. Suppliers thriving in this market anchor themselves in transparency, often providing batch traceability down to lot numbers and source origin. My own experience with suppliers tells me that market leaders respond quickly to information requests, and digital tracking has improved both safety and compliance in the movement of chemical raw materials worldwide.