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Dilute Phosphoric Acid BP EP USP Pharma Grade

What Is Dilute Phosphoric Acid BP EP USP Pharma Grade?

Dilute phosphoric acid, produced under British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP) standards, is a solution prepared by adding water to concentrated phosphoric acid. This form appears as a clear, colorless liquid with no discernible odor. Professionals in the pharmaceutical field recognize this quality for its ability to meet exacting standards where high purity and consistency play crucial roles. The liquid’s texture and clarity must remain free of visible impurities or suspended matter. Quality in this context means the absence of color tinge or contamination, something end users in drug manufacturing depend upon to achieve reproducible results batch after batch.

Physical and Chemical Properties

The molecular formula for phosphoric acid stands as H3PO4. In diluted form, commonly used strengths hover around 10% w/v, though concentrations shift to fit certain pharmaceutical specifications. The density of dilute phosphoric acid at room temperature (20°C) falls close to 1.05 g/cm3 at a typical 10% solution, though this value rises with more concentrated solutions. The material does not exist as a solid under normal storage conditions; instead, it flows freely, resembling water. In laboratories, concentrated phosphoric acid can appear as a viscous, almost syrupy liquid, while the dilute solution feels much lighter and less sticky. Flakes, solid, powder, pearls, and crystals are not forms delivered under this grade, as the specification requires a homogeneous liquid. Makers of solutions rely on standardized methodologies, titrating and diluting with distilled water until measured gravimetric checks read the correct specific gravity.

It possesses a typical sour taste, although direct contact with skin or eyes can cause irritation or burns, underlining the need for gloves and eye protection during handling. It remains miscible in water and dissolves easily with no precipitation, forming a true solution with a strong acidity profile. The pH lies strongly in the acidic range, generally between 1.5 and 2.5 depending on dilution. Mixing dilute phosphoric acid with alkalis or strong oxidizers may trigger hazardous reactions, as large heat releases or effervescent gas generation can result. If the acid dries, crystal formation sometimes appears as colorless, deliquescent shards, though standard storage discourages this.

Specifications and Regulatory Details

Meeting BP, EP, and USP benchmarks, the acid is tested for heavy metal limits, clarity, color, and exact concentration, assuring customer trust in every shipment. The HS Code for diluted phosphoric acid usually lists as 2809.20, assigned for this family of inorganic acids and fitting the global customs and logistics framework. Certificate of Analysis documents detail key figures, including exact percentage concentration to two decimal places, minimum assay, maximum allowable heavy metals like arsenic or lead (parts per million), chloride content, and sulfate levels. Regulatory audits sometimes include spot checks for microbial contamination, since even small deviations threaten downstream safety.

Production and Source Material

Most manufacturers draw from phosphate-rich minerals and wet-process synthesis, reacting phosphate rock with sulfuric acid to generate crude phosphoric acid. High-grade acid used for pharmaceuticals needs purification, typically through solvent extraction or ion exchange. Dilution happens with carefully measured, filtered deionized water in tanks lined to prevent leaching or corrosion. The final raw material remains strictly controlled so the finished dilute phosphoric acid shows no variation over time. Glass and high-density polyethylene containers protect the acid from impurities and accidental reaction with metals or other materials.

Safe Handling, Hazard, and Storage

Even at low concentrations, phosphoric acid can cause burns or dermatitis after extended skin contact. Anyone with open cuts should avoid direct exposure; fumes, while minimal under most lab conditions, may irritate mucous membranes in poorly ventilated spaces. Acid-resistant gloves, splash-proof goggles, and long-sleeve smocks provide ample protection. Splashes rinsed quickly with copious water usually prevent severe harm. Storage requirements call for containers with tight seals, out of reach of children and away from basic chemicals, metals, or food storage locations. Spills need immediate cleanup using neutralizing agents like sodium bicarbonate, followed by plenty of water to flush residues down suitable drains, as local environmental safety standards direct.

Transportation remains regulated, classifying dilute phosphoric acid as a hazardous liquid under most international guidelines due to corrosive properties. Labeling features hazard pictograms, risk phrases, and first aid information, reflecting the importance of rapid response if an accident happens in the supply chain. Always check containers for leaks, corrosion, or broken seals, since slow drips can lead to long-term environmental contamination. The acid remains stable in storage provided exposure to heat and direct sunlight is minimized, as high temperature drives evaporation, increasing concentration and thus risk.

Applications and Importance in Pharmaceutical Manufacturing

My past work in pharmaceutical quality assurance exposed just how essential compliance with BP, EP, and USP requirements remains. If someone skips a check, small impurities can pass unnoticed, affecting the stability, absorption, or safety of drug products. Phosphoric acid’s primary role involves creating buffer systems, adjusting pH to the range medicines require to dissolve correctly or stay active. It is a component in dental formulations and a leavening agent in medical-grade excipients. On several audits, clients asked about the assurance against metallic contamination—something only rigorous, well-documented sourcing could guarantee.

In the broader context of global medicine supply chains, farm chemical grades or food additives lack the guarantees critical for injectable or ingestible therapies. Working through paperwork, verifying batch numbers, and matching every property to the official specification prevents costly recalls and keeps patient health the clear priority. Multiple instances have shown that improper handling or use of substandard material triggered batch failures—something no company wants to experience, financially or ethically.

Potential Solutions to Issues Raised

A few common issues stand out in my experience. First, confusion about which grade to use in which process can lead to risks. Training staff at the receiving dock, as well as regular refreshers for production staff, help prevent the accidental introduction of industrial grade acid into pharmaceutical processing. Detailed record-keeping linked with barcode tracking reduces human error, showing exactly which shipment enters which process line. Regular communication with suppliers, including transparency into their purification steps and laboratory results, plays a big part in building confidence.

In small and mid-size labs, limited storage can amplify risks associated with accidental mix-ups or cross-contamination. Physical separation of acids for pharmaceutical versus technical purposes solves many such issues. Labels in local language and clear, color-coded chemical containers also reduce confusion for multinational or shift-based workforces. Both the software and the culture must value double-checks—outside audits from accreditation bodies provide an extra layer of security. Published recall lists from agencies like the FDA help laboratories avoid questionable supply channels. Investing in quality up front prevents larger harms years down the line.