Cholesterol BP EP USP Pharma Grade: Description and Key Details

What is Cholesterol BP EP USP Pharma Grade?

Cholesterol BP EP USP Pharma Grade stands out as a raw material deeply rooted in pharmaceutical manufacturing, laboratory work, and research development cycles. This compound carries the chemical name Cholest-5-en-3β-ol and carries a CAS Number 57-88-5. It draws attention because of its essential role in constructing cell membranes and acting as a substance involved in drug formulation. The product has a molecular formula of C27H46O, which spells out 27 carbon atoms, 46 hydrogen atoms, and a solitary oxygen atom. The structure reveals a tetracyclic ring familiar to anyone versed in steroid chemistry, with a hydrophobic backbone and a single polar hydroxyl group. These physical traits make the substance both a building block for biochemical pathways and a practical ingredient in pharmaceutical solutions.

Physical Characteristics and Properties

Cholesterol BP EP USP Pharma Grade appears as a white to slightly off-white, crystalline solid. Handling it brings to mind the sensation of fine flakes or compressed powder, reminiscent of dense snow. Granular consistency isn’t rare depending on the batch, but pearls or tiny solid granules crop up too. It does not exist in a liquid form at room temperature, remaining solid and stable. If a solution is needed, one relies on heated solvents or compatible organic solutions to dissolve this otherwise insoluble compound. Density measures at approximately 1.067 grams per cubic centimeter, so it feels solid and weighty when compared by volume to less concentrated organics. Its melting point ranges between 146°C and 150°C, and only at those temperatures does it become fluid.

Chemical Features and Specifications

The product falls under the HS Code 29061300, which groups it with cyclic alcohols based on international customs guidelines. The chemical structure grants it poor water solubility but good affinity for organic solvents such as chloroform, ether, or alcohol. This particular trait requires users to pay close attention to solvent choice during production steps, formulation, or any analytical work. The BP, EP, and USP monikers reference compliance with British Pharmacopoeia, European Pharmacopoeia, and United States Pharmacopeia standards. These quality marks mean the cholesterol passes stringent purity and contamination checks, crucial in minimizing the risk of adulterants or unsuitable byproducts, especially in medications where even low levels of impurities can spark concern.

Material Forms and Use in Industry

Purchase orders can result in delivery as bulk powder, flakes tightly packed into containers, or sometimes as larger pearls that resemble gritty gravel. The material does not ship as a true liquid or in premade solutions, so handling focuses on weighing, powder transferring, and slow dissolution using solvents. Applications span wide, ranging from intravenous lipid emulsions, excipient production, or starting points for hormone synthesis. The medical and biotech fields value its consistent particle size and ease of handling. In food and nutraceuticals, only USP- or EP-grade batches find a home due to purity demands. The quality checks run deep: specific rotation, loss on drying, sulphated ash, heavy metal content, and polymorphic form all tested against guideline ranges to make sure safety and efficacy track with industry demands.

Safety, Hazard, and Safe Handling

Despite cholesterol's star role in the body, the industrial substance brings OSHA hazard statements. It does not qualify as acutely toxic in the conventional sense, but inhaled dust can irritate the respiratory tract and cause discomfort. Direct skin contact with the solid does not typically lead to reactivity, though gloves prevent contamination and dry skin. Spilled solid can cause slip hazards or disperse powder in the air, so responsible storage inside air-tight drums or double-bagged containers is routine. Chemical suppliers provide safety data sheets warning against inhalation, eye contact, or high-temperature exposure. Although not listed among the most hazardous chemicals, assessment includes the usual scrutiny for allergens, storage incompatibilities, or dust buildup.

Issues and Solutions around Raw Materials Quality

Consistent quality in cholesterol raw material sets the foundation for safe pharmaceuticals and accurate lab research. Poor purity, contamination with plant sterols, or mislabeling have real-world effects—from failed product batches to health concerns. Regulatory bodies demand evidence at every step, including batch records, chromatography data, and impurity spectrums. Lapses in quality mean remediation, lost time, and shaken client trust. To solve this, leading suppliers sample each batch using HPLC, FTIR, and mass spectrometry. Strong collaboration between purchasing departments and QA/QC analysts keeps standards front and center. Sourcing directly from audited and accredited plants forms the backbone of transparency in the supply chain. Using BP, EP, or USP verified lots guarantees that the only thing entering the process is fit for human use, with all the right characteristics written in the numbers.