Sunset Yellow BP EP USP Pharma Grade: Comprehensive Product Description

What is Sunset Yellow BP EP USP Pharma Grade?

Sunset Yellow BP EP USP Pharma Grade belongs to the category of synthetic azo dyes, recognized by its bold orange-yellow hue. Chemically known as disodium 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonate, Sunset Yellow follows strict pharmaceutical standards set by BP, EP, and USP. This alignment guarantees the dye fits high-end purity needs for pharmaceuticals, holding steadfast against contaminants that do not meet safe consumption limits. The product's reliability means drugmakers and ingredient suppliers set high expectations for each batch—they keep an eye on purity, composition, and regulated impurity limits.

Products and Raw Materials

Using a carefully managed combination of base raw materials, Sunset Yellow springs from petroleum-derived aromatic chemicals. These include naphthol and sulfanilic acid, charged with the signature azo bond that fuses to give the colorant its identity. Fully synthesized, neutralized, and filtered, its stable existence emerges as a pure orange to yellow powder, granule, or occasionally a crystalline flake. No shortcuts lead to food-grade quality—the raw input matters. Each production run tracks all material origins for traceability and regulatory checks, limiting migration of undesired substances as demanded by health agencies across the globe.

Chemical Properties and Structure

Molecular formula for Sunset Yellow stands as C16H10N2Na2O7S2, laying out the framework that underlies its coloring properties. Its structure houses azo double bonds anchored between aromatic rings, weighted by the presence of sulfonate groups. This design not only ensures solubility in water but also delivers resistance against most polar solvents. A key molecular property of Sunset Yellow is its stability; it holds up through pH variations normal to pharmaceutical compounding, remaining unchanged under many processing temperatures. Density clocks in around 1.27 g/cm³ (solid form), matching reference pharmacopeial data. It disperses in water with ease, leaving behind an intense coloration suitable for carefully measured dosing in medicinal applications. Atomic arrangement influences everything from shade strength to toxicology profile, so pharmaceutical batch records keep tabs on molecular signature and impurity percentages.

Physical Forms: Powder, Granules, Pearls, and Solutions

Sunset Yellow BP EP USP Pharma Grade usually enters the market as an orange-yellow powder. Larger volume users sometimes prefer granules or even pearls, all designed to boost handling in industrial environments. Each form shows different dusting properties and bulk density, yet all dissolve rapidly in both cold and warm water. Liquid or solution options often serve laboratories or compounding pharmacies where precise dosing and fast reconstitution mean less risk of error. On the bench, crystals of Sunset Yellow are brittle, but powders spread fine and even. The product’s bulk density in powder form averages between 0.55 and 0.85 g/ml, shaped by milling and agglomeration steps. Each batch sits sealed in moisture-proof packaging, as humectants and direct light degrade color stability faster than most expect. Reliable coloration only comes if the material stays dry, free-flowing, and uncontaminated.

Specifications, HS Code, Packaging

For regulatory compliance, Sunset Yellow BP EP USP Pharma Grade submits a precise panel of specifications. Heavy metals remain below 10 ppm, arsenic stays under 3 ppm, and water insoluble matter barely exceeds 0.2%. The product must clear lead, mercury, and bacterial endotoxins tests before it ships to pharmaceutical partners. The HS Code for reference is 3204.12, falling under synthetic organic coloring matter. Packaging plays its own part—usually 25 kg fiber drums, lined with double polyethylene bags—blocking sunlight, oxygen, and moisture from the moment of manufacture to last dose administration.

Safety, Hazards, and Handling

Evaluations of Sunset Yellow’s safety run on decades of toxicological review published by EFSA, FDA, and related pharmacovigilance authorities. At medically accepted doses, the product sits inside established safety margins. Intake exceeding limit thresholds, though, brings the potential for allergies in sensitive individuals or rare (yet notable) intolerance responses. Workers in manufacturing settings wear gloves, goggles, lab coats, and dust masks to curb particulate inhalation. With strong acid or base exposure, chemical breakdown releases smaller azo fragments that can harbor risk. Many labs store the dye in dry, room temperature conditions, and keep inventories low to minimize excess exposure. Signs warn of irritating dust clouds, and company MSDS sheets advise spill cleanups with industrial vacuums, never dry brooms.

Discussion: Why These Details Matter and Moving Forward

Every specification, from molecular formula to final packaging, shapes real outcomes in drug safety and quality. This level of control stems from lessons pharmacy professionals and manufacturers learn working with colorants under tight guidelines. Hearing from pharmacists, there have been cases where using lower-grade dye meant unexplained color shifts, and these little issues sometimes hid bigger compliance problems. Suitably pure Sunset Yellow, used at regulated concentrations, gives a reliable visual cue for dosing without threatening safety when routines are followed. Visibility into sourcing and documentation around every shipment calms concerns among QA managers and regulators. A responsible route forward starts with verifying each specification and keeping full records. Where concern rises over intolerance or allergic responses, alternative colorants should be made available, and public health communications about intake limits and possible adverse effects need sharper attention.