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Dl-Malic Acid BP EP USP Pharma Grade brings more to the table than most people realize. Recognized for a sour taste, this synthetic compound doesn’t just stop at flavoring beverages or confectionery. The chemical name goes deeper: 2-hydroxybutanedioic acid, with the formula C4H6O5. Its two forms—D and L—get combined for pharmaceutical use, balancing consistency and performance. In pharma manufacturing, purity marks the line between safe medication and failed batches. With this pharma grade, strict specifications bring reliability to each application, from tablets to syrups.
In its purest state, Dl-Malic Acid comes off as a white crystalline solid. Pausing in a lab and handling the substance, you notice distinct flakes or sometimes chunky powder. Sometimes manufacturers prefer pearls or tightly packed crystals for easier dosing. Powdered versions flow easily into mixing tanks, which means no clogging at hopper feeds. The solid form melts at 130°C, showing its stability in heat-sensitive ingredients. Water draws malic acid in fast, with high solubility—making it the go-to for solutions and liquid blends. The density sits around 1.601 g/cm3, neither especially heavy nor feather-light, but enough to calculate accurate dosages in both small-batch and bulk productions.
Dl-Malic Acid BP EP USP Pharma Grade lands under HS Code 2918.19.0090, which covers a range of carboxylic acids but singles out products destined for regulated pharmaceutical use. Compliance with BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia) standards demonstrates quality and consistency batch after batch. Samples need to clear tests for heavy metals, sulfates, clarity, and loss on drying; those in the industry know that even slight deviations can mean a halt in production. Safety data plays a big part for warehouses: storage in cool, dry rooms with non-metal shelving helps keep the acid stable, and labeling regulations reduce the risk of cross-contamination.
Dl-Malic Acid doesn’t cause problems under most handling conditions. It won’t ignite easily, and the risk of hazardous reactions stays low if kept away from oxidizers. Direct contact with the powder may irritate skin or eyes, so gloves and goggles become part of the daily kit in factories. Inhalation of fine dust can cause coughing or discomfort, making dust extraction key in packaging areas. Spillage cleanup involves dilution with water; the acid dissolves, breaks down fast, and doesn’t leave a lasting mark on surfaces. Still, workers remember that the acid should never pour directly into strong concentrated bases, as sudden reactions can throw off workplace harmony. Waste handling lands under local regulations, often directing neutralization before draining any solution.
Dl-Malic Acid in its various shapes—flakes, powder, crystals, or liquid—fits the growing needs of pharma labs and factories. Tablets rely on the powder’s gentle acidity to adjust pH, while oral syrups benefit from the acid’s clean, sharp taste without unwanted residue. Liquid blends stir into solutions, ensuring no lag in efficacy for injectables or soft gels. The molecular structure, with two carboxylic groups and one hydroxyl, reacts predictably across formulations, providing reproducibility for patented drugs or generic products. Process engineers choose the form that minimizes waste and maximizes throughput, from precision milling of crystals to automated feeding of flakes.
Every batch of Dl-Malic Acid draws a paper trail from raw material sourcing to finished product. Factories scan in documentation at each stage, so regulators can track quality from the first chemical precursor to the bottles lined up in pharmacies. Sourcing transparency helps avoid contamination or fraud—a must since counterfeit inputs elsewhere have sparked recalls and endangered lives. Companies count on third-party audits, in-house spectroscopic analysis, and annual reviews to back up their claims. Anyone in supply chain management knows the value of a full certificate of analysis; those numbers aren’t just paperwork but a guarantee that the round white pill delivering relief matches the standard written down in every pharmacopeia.
Despite a solid safety record, Dl-Malic Acid earns a classification as an irritant. Toxicity tests show no evidence of serious harm at intended dosages, with oral LD50 values far above daily pharmaceutical use levels. If inhaled in bulk or exposed over many hours, some discomfort exists, but so does training and PPE. The acid does not bioaccumulate, ensuring environmental discharge—where allowed—breaks down naturally. Still, responsible plants monitor discharge, as even safe acids can disrupt small ecosystems if left unchecked. Spills don’t spark environmental emergencies but prompt swift response to avoid regulatory headaches.
For all these technical details, Dl-Malic Acid’s real impact appears in finished medication, not in raw chemical bags. Its controlled release properties help kids swallow antibiotics without grimacing; its buffering power stabilizes life-saving vaccines against spoilage. As regulations tighten, strict adherence to BP EP USP standards doesn’t just mean better business for factories but safer drugs for everyone. Drilling down into specifications and traceability, the quality of this acid transforms from paperwork into peace of mind for patients, pharmacists, doctors, and the entire healthcare system.
Chengguan District, Lanzhou, Gansu, China
