85% Glycerol (For Injection) BP EP USP Pharma Grade: Product and Properties

What is 85% Glycerol (For Injection)?

85% Glycerol (For Injection) BP EP USP Pharma Grade works as a cornerstone in the pharmaceutical landscape, shaping both small-scale compounding and industrial manufacturing. Sourced as a colorless, odorless, and viscous liquid, glycerol has organized itself as one of the most adaptable raw materials for injectable formulations. Crafted to meet the rigorous demands of BP, EP, and USP standards, this compound steps in as a trusted vehicle or excipient where purity and safety sit at the top of the checklist. The material features a proportion of glycerol diluted with about 15% water by weight, establishing it as a semi-concentrated, readily miscible medium. Glycerol’s track record in intravenous, oral, and topical formulations roots itself in history, with dozens of peer-reviewed publications emphasizing its tissue compatibility and low-toxicity profile. Compliance with strict pharmacopeial standards means reliable identification, quantitation, and traceability right down to the batch.

Structure, Molecular Information, and Formula

From a chemical angle, glycerol’s backbone consists of three carbon atoms, each bearing a hydroxyl group, giving rise to a trihydroxy alcohol with the chemical formula C₃H₈O₃. This triply hydroxylated structure translates into strong hydrophilic character, allowing seamless solubility in water. When the concentration reaches 85%, the solution maintains a balanced osmolarity essential for injection applications, avoiding cellular distress. By keeping a close eye on the three hydroxyl groups, researchers have built a knowledge base explaining why this molecule shields against denaturation in protein drugs or acts as a cryoprotectant. Each molecule stacks together through hydrogen bonding, resulting in marked viscosity and a high boiling point beyond 290°C.

Specifications and Standards

Regulatory authorities tie expectations for injectable-grade glycerol directly to compliance with BP, EP, and USP monographs, which detail allowable impurity levels, identification tests, UV absorbance cut-offs, and microbial purity. Production lines run with cGMP-trained workers in validated facilities, guarding against cross-contamination and environmental toxins. The material passes stringent assays for water content, chloride, sulfate, heavy metals, and reducing sugars, often verified using titration and IR spectroscopy. Quality documentation also lists a Certificate of Analysis with every lot dispatched, providing transparent numbers for purity, density, and compliance points. GMP and pharmacopoeial compliance answer both regulatory scrutiny and patient safety, confirming no unknown alien compounds ride along.

Physical Appearance and Forms

This grade of glycerol adopts a thick, syrupy liquid state at room temperature, pouring steadily without sediment or visible crystals. Its highly viscous nature slows its flow, but it mixes faster than honey once incorporated with other water-based media. The product holds a density of about 1.25 g/cm³ at 20°C, a critical attribute engineers monitor for precise dosing in automated systems. Unlike laboratory-grade or industrial glycerol, which may hold color impurities or by-products, pharma-grade 85% always presents as high-clarity, nearly transparent fluid. Occasionally, in colder environments or over extended storage, the solution might form supercooled regions, yet it doesn’t crystallize in flake, powder, or pearl-like morphology. Plainly, injectable grades skip fancy packaging or decorative forms, focusing on liquid for compatibility in syringes and mixing vessels.

HS Code and Trading Regulations

On the global trade scene, 85% Glycerol for injection is mapped under the Harmonized System Code 29054500, distinct from technical-grade or crude glycerol commonly sourced from biodiesel by-products. Customs officers, regulators, buyers, and warehouse managers reference the HS Code to segregate medicinal raw materials from cosmetic or food-use substances, ensuring all cross-border paperwork stands in line with import quotas, excise, and licensing rules. Open declarations of HS Codes also speed up regulatory submissions, label accuracy, and recall processes if issues arise.

Material Safety, Handling, and Hazards

Glycerol ranks as one of the safest chemicals found in industrial or hospital settings. Standard toxicology reports cite no recordable carcinogenicity, mutagenicity, or reproductive harm. Still, every formulation scientist knows that improper handling, such as large accidental ingestion or injection beyond clinical limits, can tip the scales toward osmotic diuresis or hemolysis. Safety Data Sheets highlight that the 85% solution presents minimal irritation upon skin or eye contact and essentially no detectible volatility under normal temperatures. Transport containers, whether drums or carboys, require sealed closures to avoid water absorption and contamination. For medical staff and technicians, hand gloves and eye protection deliver enough defense against rare spillage; there’s no long list of harmful vapor or fine solid handling requirements. Emergency response to a spill means mopping up the viscous fluid with damp, absorbent pads and rinsing with water—no reactive cleanup steps, hazmat suits, or negative-pressure isolation needed. Every user, from pharmacists to logistics handlers, expects origin traceability, batch analytics, and expiration documentation to guarantee only safe material enters supply and patient use chains.

Role as Raw Material in Pharma Manufacturing

You find 85% injectable glycerol taking up space on the shelves of formulation labs and fill-finish plants, ready for synthesis, stabilization, or direct compounding. Well-trained pharmacists and production engineers view it as not just an additive, but an essential excipient for parenteral nutrition, as an osmotic diuretic for acute kidney treatments, and as a bulk vehicle for organ preservation solutions. Beyond hospital injection rooms, researchers experiment with how its molecular geometry protects enzymes, maintains isotonicity, and softens harsh drug compounds. Regarding solution preparation, the ingrained viscosity shapes both manual handling and machine mixing, so automated systems calibrate rigorously for every batch change, avoiding under-diluting or overdosing. Excess or improper use requires rapid correction; unlike many chemicals, 85% glycerol doesn’t just fade away—it affects product density and solute compatibility.

Industry Experience and Watchpoints

For anyone working in pharmaceutical production or sterile compounding, 85% Glycerol’s reliability builds a sense of security. Knowing it will not suddenly introduce unwanted color changes, sedimentation, or pH drift lets batch operators sleep easier. Every step from container selection, transfer into mixing tanks, and in-line sterile filtration draws on the lived experience of technical staff: minimize exposure to air, keep drums closed, track lot numbers, and never substitute with food-grade or technical grades in patient-facing applications. International recalls and contamination scandals have historically traced back to errors with glycerol sourcing and mislabeling, pushing strict supplier audits and end-to-end traceability. The bottom line is that every hospital, clinical trial, or drug manufacturer leans on trusted, well-characterized pharmaceutical-grade glycerol to avoid treating quality as an afterthought.