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Sucrose (For Injection) BP EP USP Pharma Grade: Description and Physical Characteristics

What Is Sucrose (For Injection) BP EP USP Pharma Grade?

Sucrose (For Injection) BP EP USP Pharma Grade comes from highly purified cane or beet sugar, processed to strict standards that meet specifications set by the British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP). Those working in the pharmaceutical industry recognize it as a white, crystalline solid free of color, odor, and visible impurities. Producers refine every batch so it remains consistent, dissolves completely in water, and avoids contamination by other sugars or organic material. You find this material in a range of medical products, most often as a stabilizer, osmotic agent, or cryoprotectant. Its level of purity supports its use where patient safety and regulatory compliance drive every decision. In facilities across the world, pharma-grade sucrose moves from verified raw materials to the end product under monitored, validated conditions.

Properties of Sucrose for Injection

This pharmaceutical-grade sucrose holds the chemical formula C12H22O11 and a molecular weight near 342.30 g/mol. It appears as colorless or white crystals with a sweet taste. Its melting point hovers around 185–186°C, which leads it to soften and caramelize above this range instead of boiling. You can identify it almost instantly by its high water solubility, reaching concentrations of around 2000 g/L at room temperature. Sucrose more or less disappears into solution without cloudiness when dissolved with pure water. Its density, in solid form, lies close to 1.587 g/cm³, making it compact for storage and transport in the solid state. As a finished product, it may take the form of flakes, powder, crystalline solids, or even pearls, depending on the pharmaceutical supplier’s process and customer needs. The substance remains non-toxic in its purified form, which allows it to support injectable formulations required for human use. In terms of reactivity, sucrose itself presents as chemically stable in neutral solution, displaying no hazardous or harmful tendencies under normal storage or handling.

Structure and Analysis

The molecular structure of sucrose reveals a disaccharide composed of one glucose unit and one fructose unit joined by a glycosidic bond. This specific linkage—an α-(1→2) bond—provides sucrose with its chemical and physical properties, such as a lack of reducing capability, solid form at room temperature, and ease of crystallization. Laboratory analysis, driven by pharmacopoeial requirements, involves HPLC, polarimetry, and purity assays that reject the presence of invert sugar or other disaccharides. Microbiological standards apply throughout production and storage, ensuring the material enters a compounding environment as essentially sterile when further processed for injection. Chemists rely on its consistent structure and physical characteristics, like refractive index and optical rotation, to assure each lot complies with pharmacopeial requirements.

Specifications and Compliance

Sucrose (For Injection) BP, EP, USP Pharma Grade demands precise compliance with compendial standards. Physically, the material appears free of visible particles, dust, or foreign matter. Specifications require moisture below 0.1% and the absence of heavy metals, arsenic, and other regulated contaminants. Water solubility tops the list of requirements, with residues after dissolution not permitted. The product’s HS Code for international trade is 17019910, identifying it as pharmaceutical sucrose intended for medical markets. Regulations further dictate labeling relating to batch number, expiration date, manufacturing site, and raw material traceability, so users always know the origin and safety status of the sucrose supplied. Analytical data backs every certificate of analysis, including polarimetric readings for purity and specific rotation, loss on drying, and microbiological data. Any presence of bacterial endotoxins, pyrogens, or hazardous chemicals means the material fails regulatory hurdles and cannot enter the pharmaceutical supply chain.

Molecular and Physical Properties

Sucrose's molecule contains twelve carbon atoms, twenty-two hydrogen atoms, and eleven oxygen atoms. Its arrangement confers an ability to bind water molecules, supporting use in parenteral solutions where osmotic strength is needed. Unlike simple sugars, sucrose holds a stable, non-hygroscopic form when kept in sealed containers below 25°C, defending itself against clumping and spoilage. This matters for long-term storage in wholesale and hospital settings alike. Its near-neutral pH in solution reduces the risk of irritation upon injection and gives formulators flexibility in designing final products for diverse medical needs, such as vaccines, IV infusions, and biologicals. Its granular or powdered texture pours easily, and when processed, manufacturers grind it to the precise particle size distribution required for dissolving without residue.

Applications and Handling Safety

Sucrose (For Injection) BP EP USP forms the backbone of injection solutions, stabilizers in vaccines, intravenous fluids, and cell culture support media. Its nontoxic nature, backed by extensive testing and a long track record, supports its use at clinically relevant doses, where its role centers around providing osmolarity or serving as a carrier. Regulatory authorities consider it safe in pharmaceutical form; accidental exposure or skin contact presents minimal risk provided it stays in its purified, intended use case. During handling, wearing gloves and standard PPE remains best practice to avoid cross-contamination, but the material stands as non-hazardous and non-flammable. Only gross contamination, improper storage, or accidental mixing with other chemicals could lead to any risk in a compounding or manufacturing setting. Material safety data sheets provided with every shipment reinforce this record, highlighting practical advice rather than warning of acute or chronic toxicity.

Raw Material Integrity and Quality Control

Pharmaceutical sucrose begins with the selection of high-quality raw sugar, filtered and recrystallized in facilities outfitted for sterile manufacturing. Each batch undergoes extensive purification, decolorization, and deionization, with frequent monitoring for residual solvents, microorganisms, and metals. The finished product moves from closed reactors to secure, tamper-evident packaging, all under Good Manufacturing Practice (GMP) conditions. This journey from raw material to final product ensures integrity every step of the way. Customers demand full transparency, so manufacturers invest in tracking systems that link every lot to its origin, processing history, and test results. This creates certainty for healthcare providers that every dose prepared from sucrose (for injection) is safe, fit for purpose, and able to support critical patient needs without introducing risk. Quality assurance teams perform batch release only after reviewing full compliance documentation, taking no shortcuts in safeguarding patient safety.