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Vitamin C BP EP USP Pharma Grade refers to ascorbic acid manufactured and tested by standards set in British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP). These certifications guarantee strict quality needed for sensitive uses like pharmaceuticals. The product appears mainly as a white or almost white crystalline solid, with a tart taste and an evident acidic bite when sampled. Its molecular formula stands at C6H8O6, matching a molecular weight of 176.12 g/mol. It comes in several physical forms: fine powder, delicate crystals, sometimes small pearl-like droplets, and infrequently offered dissolved in medicated solutions. Flake form or dense granule form remains rare but not impossible. Information about its precise density points to about 1.65 g/cm³, which helps when weighing out exact doses or dissolving in water for solution preparation. Stability changes significantly with heat, air, and light—making airtight, light-resistant containers a non-negotiable part of safe storage.
Digging deeper into Vitamin C’s physical traits, it dissolves quickly in water, creating a colorless, transparent solution at room temperature. Ethanol takes more time, though the substance rarely leaves residue unless tainted. Solubility hovers around 330 g/L at 20°C, making it ideal for injectables, drips, or supplements where a potent dose in a small volume counts. Structurally, ascorbic acid exists as a six-carbon lactone and contains an enediol group inside a furan ring, active in redox reactions. It works as a ruthless antioxidant, neutralizing free radicals that attack cells. The raw material is often synthesized through advanced chemical fermentation methods starting from glucose, employing microbial action for precursors like sorbitol or sorbose.
Pharma-grade ascorbic acid must exceed strict limits for contaminants. Content percentages usually test above 99%, meeting or outperforming pharmacopeial monographs. Specifications include appearance (white to almost white powder/crystals), solubility (clear in water), identification by IR or UV spectra, pH of solutions (2.2 – 2.5 at 2% w/v), and clarity. Heavy metal content like lead, arsenic, or mercury cannot cross limits as low as 1 ppm. Absence of harmful byproducts such as oxalic acid or residual solvents follows by repeated batch testing. Microbial purity stands high, ruling out total bacteria, molds, and yeasts that could lower shelf life or bring infection risks. The HS Code for Vitamin C in raw, unblended form lands at 29362700, a detail necessary for global trade, customs, and compliance.
While most buyers encounter vitamin C as powder or granular solid, pharmaceutical users sometimes see it as pearls—small, beadlike forms suitable for sustained-release capsules. Food-grade and pharma-grade often separate by appearance: pharmaceutical types undergo extra filtration and post-treatment to achieve a higher clarity in water and longer stability. Liquid vitamin C, used in some hospital drips, starts from pure powder dissolved in sterile water at calculated concentrations, sealed in ampoules or vials to prevent oxidation. Flakes and crystalline material spread evenly in precise blends for medication or enrichment of foods for people at risk of deficiency. The solid state—powder or crystals—shows the lowest risk of degradation, though even then, air, moisture, or high temperatures speed up breakdown to inactive dehydroascorbic acid.
Handling ascorbic acid rarely brings health hazards at routine levels, but unsafe storage or poor handling piles up problems. Dry, dark, cool storage spaces extend shelf life for months or even years. Moisture accelerates spoilage, making airtight, tamper-proof packaging vital for bulk storage or finished goods. At high concentrations, the irritant potential rises—frequent skin contact or accidental inhalation of dust triggers mild irritation or sneezing. GHS labeling classifies it as “not hazardous” in most jurisdictions, but bulk facilities treat dense clouds of powder as possible combustible dust under safety codes. For operators, gloves and light respirator masks prevent mishaps. Disposal rarely brings regulatory headaches, as breakdown returns harmless carbon-based molecules to water—but checking local environmental codes avoids errors.
Ascorbic acid BP EP USP Pharma Grade acts as a foundational chemical in many formulations—oral tablets, multivitamin capsules, injectable vitamin infusions, and topical gels for wound healing. In my experience working with supplement manufacturers, the pressure mounts to keep every input traceable and as pure as chemistry allows. Any impurity in the raw acid ripples through to the final medicine, so everyone from the procurement team to lab techs must check documentation and certificates of analysis batch by batch. Tracing the source—often sugar refinery byproducts channelled through complex fermentation—helps guarantee repeatable quality. The drive for “clean label” products, free from allergens, heavy metals, and synthetic byproducts, depends almost totally on rigorous standards at the raw material stage.
This specialty grade floods into pharmaceuticals, but industries making skin serums, fortifying dairy or plant-based milks, or producing animal feeds lean on the same BP EP USP-accredited supply lines. The market asks for tight control at every checkpoint, which includes tamper-proof seals, full traceability paperwork, and analytical results published alongside each lot. Brands pay a premium for pharma-compliance because regulatory agencies can, and do, pull products for violations. Even in animal feeds, the presence of “off-spec” vitamin C risks animal welfare, shelf life, and—at scale—potential legal headaches. For manufacturers, consistency in powder density, chemical content, and water content makes scaling up production lines possible without costly interruptions.
Supply chain disruptions can turn production scheduling into chaos, especially when just-in-time delivery breaks down. The move toward globalized ingredient sourcing puts local manufacturers on edge, since delays in customs or missing HS Code paperwork hold up raw materials vital for patients and consumers. I remember times when a shipment of ascorbic acid sat in port for weeks over mislabeled documentation. The best answer always comes through building strong relationships with suppliers, running safety stock on the most-used ingredients, and investing early in digital platforms that flag missing compliance paperwork in real time. Another challenge comes from price shocks—often triggered by spikes in demand or shutdowns in major overseas plants. Smoothing out those price swings means broadening the approved vendor list and locking in longer-term contracts at flat pricing where possible.
Stringent rules from agencies like the FDA, EMA, or China’s NMPA shape the way Vitamin C Pharma Grade moves around the world. Missing a single step in testing or failing to report trace impurities results in product recall or blocked imports. From a public health view, verified BP EP USP certification protects patients and consumers from exposure to unsafe levels of heavy metals, agricultural residues, or illicit synthetic byproducts. Beyond paperwork, regulatory inspections increasingly focus on on-site audits—checking everything from cleanliness of equipment to security of supply chains. For people relying on medicines every day, these rules translate to real safety. For producers, the bar for compliance keeps climbing, making transparency and constant investment non-negotiable for any company in this industry.
Chengguan District, Lanzhou, Gansu, China
