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L-Malic Acid BP EP USP Pharma Grade stands out as a pharmaceutical raw material recognized under multiple global pharmacopeias, including British (BP), European (EP), and United States (USP). Holding compliance with these standards means the material has cleared rigorous purity, identification, and analytical tests. Sourced in its L-isomer form, this compound mirrors the malic acid naturally found in fruits, leading to broader acceptance and trust from formulators and regulatory bodies. Its molecular formula is C4H6O5 and its chemical structure—a four-carbon dicarboxylic acid—matches naturally occurring malic acid in apple, pear, and grape skins. Its CAS number is 97-67-6, and its HS Code for import and export is 29181980, which helps trace global shipments and regulatory paperwork.
Examining the molecule, L-Malic Acid arrives with a linear backbone distinguished by two carboxyl groups and a single hydroxyl group, which gives it acid and alcohol properties. This arrangement gives it a molecular weight of 134.09 g/mol and links directly to its physical features. The pure crystalline appearance, which can shift between solid flakes, fine powder, and crystalline pearls, carries a practical side. These forms stack easily in drums or bags, resist caking under dry storage, and deliver predictable solubility in water, ethanol, or compatible solvents. Measured at a density around 1.6 g/cm3, this substance is both heavy enough for laboratory precision and light enough for bulk handling in pharmaceutical or food industries.
L-Malic Acid BP EP USP Pharma Grade distributes in several physical forms—solid flakes, crystalline powders, and, less commonly, pearl or granular particles. Each format results from the same raw chemical but processed to suit manufacturing lines, solubility requirements, or storage needs. Crystal-clear visual purity marks a reliable pharmaceutical product, forming colorless, odorless crystals ranging from tiny shards to large flakes. Through chilling or evaporation, the solution yields a crystalline solid, typically stored at room temperature, but it can dissolve into clear, near-neutral pH solutions at concentrations demanded by compounding pharmacists or chemical mixers.
The density of L-Malic Acid hovers near 1.6 g/cm3, aligning with other carboxylic acids and simplifying conversion calculations in factory batching. Solubility in water and alcohol stands high; a quick stir dissolves standard powder in water at room temperature without visible clumping, which matters during high-volume operations. Storage in bulk bins or drums sometimes requires moisture checks because of hygroscopic tendencies, but good warehouse management and low humidity prevent solidification or spoilage. In solid form, the powder flows smoothly, compares well to salt or sugar in consistency, and resists sticking—a relief for supply chain teams worried about downtime due to bridged silos or clogged pipes.
In decades of industry, handling L-Malic Acid in pure BP EP USP Pharma Grade rarely triggers hazardous events if good chemical hygiene is in place. On the gloves, direct skin contact can feel mildly irritating after long exposure, but quick washing resolves it. Inhalation of fine dust should be avoided, but warehouses with basic ventilation and routine face mask use see minimal risk. Ingestion at pharmaceutical levels follows regulatory dosage; outside that, high concentration may upset digestion and rarely leads to mild gastrointestinal irritation. Material safety data points record L-Malic Acid as non-flammable and chemically stable; reactive behavior only appears under strong acid or base treatment—scenarios uncommon in standard pharmaceutical sites.
Each batch produced under BP EP USP standards lists a tight range of assay, pH, loss on drying, residue on ignition, sulfate content, chloride levels, and identification by IR or HPLC. Compliant batches consistently grade assay levels above 99% purity and show minimal impurities—all critical for medicinal compounding and injectable preparations. Regulatory authorities, including the FDA and EMA, call for tough batch traceability, outlined in Certificate of Analysis documents, and confirm raw material integrity from drum to tablet form. Pharmaceutical teams validate raw material specs at intake and maintain lot traceability.
L-Malic Acid BP EP USP supports a wide spread of pharmaceutical developments, from injectable buffers to excipients adjusting pH in oral dissolvable films, syrups, or tablets. Its strong buffering capacity holds pH steady in both acidic and near-neutral ranges, protecting delicate active ingredients from hydrolysis. In personal experience working on oral formulations, L-Malic Acid can outperform citric acid when formulating pH-sensitive molecules in pediatric preparations, since its taste profile skews less tart, helping improve compliance for young patients. Recent patents show its use in extended-release tablets, buccal films, and even as a chiral resolving agent during active pharmaceutical ingredient synthesis—demonstrating its versatility.
Unlike caustic chemicals, L-Malic Acid’s primary risk comes from dust, which can irritate eyes and airways. Safe storage in sealed containers, dry work environments, goggles, and gloves lower the risk for lab workers. I have seen teams respond quickly to spills by sweeping and mopping rather than resorting to emergency gear—a clear sign of its low hazard footprint in comparison to warehouse threats posed by aggressive bases or strong mineral acids. Manufacturers should keep clear separation from incompatible substances but rarely face catastrophic risks on the plant floor.
Production and storage teams can improve safety records by running periodic moisture checks and dust collection tests in their supply chain. Barcode or RFID systems streamline tracking both raw material and finished lots, building better food and drug traceability. On lab benches, switching from open scoops to enclosed powder dispensers reduces airborne dust and improves batch consistency. Increased staff training and regular reviews of Material Safety Data Sheets promote chemical respect and prevent slip-ups better than rarely updated wall charts. By focusing on day-to-day experience—reasonably priced PPE, practical container handling, and up-to-date documentation—companies help bridge the gap between chemical safety theory and real-world performance.
Chengguan District, Lanzhou, Gansu, China
