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Steviol glycosides come from the leaves of Stevia rebaudiana, a plant known for its sweet compounds. This substance is processed and refined to meet the standards set by the British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP) for pharmaceutical applications. These grades guarantee a higher level of purity and consistency, suitable for medicinal, supplement, and food products. The common appearance includes odorless, white or off-white solid flakes, crystalline powder, small pearls, or occasionally, compressed as tablet or granular forms.
Each molecule of steviol glycoside features a complex carbohydrate structure bound to the steviol backbone, a diterpenoid aglycone. The molecular formula for stevioside, a major component, reads as C38H60O18. The exact formula shifts depending on the precise glycoside mixture, such as rebaudioside A or dulcoside A. Manufacturers extract and purify these using water or alcohol-based methods, leaving behind crude elements and concentrating the molecules that provide sweetness. The molecular weight for stevioside stands at about 804.88 g/mol, and for rebaudioside A at 967.01 g/mol. Its density falls between 1.4-1.6 g/cm3, resembling that of many crystalline carbohydrates. Melt point typically holds near 238°C, indicating robust stability even during pharmaceutical processing.
Pharma grade steviol glycosides carry rigorous control on impurities like heavy metals, residual solvents, pesticides, and microbial content. By standard, purity surpasses 95%, often determined by high-performance liquid chromatography (HPLC) per pharmacopoeial monographs. Moisture content stays below 6%. Ash content rarely creeps above 0.2%. Common hazardous contents such as arsenic, mercury, or lead register at undetectable or well below 0.1 parts per million. Microbial testing ensures total aerobic microbial count under 1,000 CFU/g and yeast or mold counts below 100 CFU/g. The HS Code for pharmaceutical steviol glycosides tracks as 29389090, reflecting its international identification for trade and customs.
Users see pharma grade steviol glycosides sold most often as a fine, dense white powder or shiny, glass-like crystal flakes that dissolve swiftly in water and aqueous solutions. Bulk shipments sometimes use pressed pellets or pearl-like beads to enhance handling. Liquid solutions comprise steviol glycoside dissolved in purified water (sometimes ethanol), aided by gentle heating and pH control to maintain solubility. Crystals form through controlled cooling and evaporation. Each presentation plays a role: powder blends into tablets or capsules, crystals serve as reference standards and raw material, liquid preparations ease blending during manufacturing.
The safety profile rates high for pharmaceutical steviol glycosides. As a non-caloric sweetener, it does not contribute to glycemic load or dental caries, nor does it prompt an allergic response in routine use. World Health Organization documents note no observed adverse effect at doses up to 4 mg/kg body weight per day. Hazard assessment places it among the least harmful classes of chemical additives. Typical labels identify the product as non-hazardous under standard Globally Harmonized System (GHS) criteria, with transport not restricted, nor does it require special handling except to reduce inhalation of fine powder. Stevia leaves, used as raw materials, usually derive from well-managed agricultural operations in China, Paraguay, and Brazil, monitored for pesticide residues and chemical treatments. Sustainable harvesting, minimal chemical processing, and traceability from field to factory play key roles in modern supply.
Pharma grade steviol glycosides fill a crucial gap as a clean-taste, plant-sourced sweetener for cough syrups, chewable tablets, and dietary supplements meant for diabetic or obese patients. Formulators swap in these glycosides where the stability, safety, and sweetness must outperform traditional sugars or artificial sweeteners. The high melting point and low reactivity guarantee it stands up to heat or acidic conditions during tablet compression or solution bottling. Beyond pharma, these ingredients push into functional foods, beverages, pet care, and oral hygiene due to their non-cariogenic, easily dosed nature. Manufacturers often highlight the clean traceability and low residue footprint as a selling point to regulatory agencies and consumer watchdogs. Industry professionals monitor consistent batch-to-batch performance, as discrepancies might affect sweetening power and thus patient compliance.
Understanding the limits of solubility and flowability in powder mixing affects how pharma-grade steviol glycosides integrate into finished products. Fine powders sometimes clump or disperse inconsistently in mixing tanks. Occupational exposures to fine dust can pose small but real risks, so manufacturers deploy localized ventilation, sealed conveyor belts, and personal protective equipment during handling. Research teams focus on granulation, flow agents, or microencapsulation to boost handling and stability in finished form. Keeping a qualified supplier base and engaged quality assurance teams ensures every shipment aligns with BP, EP, and USP specifications. Unexpected microbial or heavy metal contamination sets off immediate retesting, safety checks, and potential recalls. These processes keep the trust of end-users and upholds the premium nature of pharma use steviol glycosides.
Steviol glycosides, processed to BP EP USP pharma grade, provide a clean, plant-based sweetening solution backed by a strong physical and chemical profile. The consistency, safety, and multi-form flexibility make a clear choice for forward-looking supplement and pharma manufacturers seeking alternatives to old-world sweeteners. The pressure stays high to guarantee material purity, high standards of traceability, and environmental stewardship while not losing sight of practical challenges in formulation or supply chain. Maintaining this balance delivers quality, safety, and acceptance for people needing sweet taste without added health concerns.
Chengguan District, Lanzhou, Gansu, China
