Policresulen Impurity 5 Ammonium Salt, known in chemical circles as M-Cresol-4-Sulfonic Acid Ammonium Salt, draws attention for both its properties and place within several manufacturing arenas. This compound serves as an intermediate or impurity referencing high-purity Policresulen, a compound more broadly known for roles in pharmaceutical and fine chemical production. The substance consists of a sulfonated m-cresol backbone with the ammonium ion neutralizing the strong acid group that characterizes its reactivity and handling profile. Laboratories and manufacturers track and control this impurity to uphold stringent drug quality standards since pharmacopoeias identify and restrict levels of each related compound.
This solid emerges most often in the form of off-white or pale-yellow flakes, crystals, or powder. Sometimes production batches reveal small, hard pearls or even granular aggregates, depending on crystallization and drying conditions. The compound’s molecular formula reads as C7H9NO3S, giving a molar mass of roughly 187.22 g/mol. With a density hovering near 1.3 g/cm3, the material neither floats nor settles drastically when dropped into standard laboratory liquids. The ammonium ion releases subtle ammonia odor under basic conditions, but its sulfonate group strongly defines its water solubility profile. Highly soluble in water, but less so in organic solvents, this ammonium derivative forms clear solutions even at high concentrations. Its solid-state crystal lattice, built around the ionic interactions between ammonium and sulfonate, results in well-packed, sometimes needle-like crystals.
Anybody involved with quality control in medicine or specialty chemicals bumps into substances like this, often wishing for tighter process controls upstream. M-Cresol-4-Sulfonic Acid Ammonium Salt functions not as a main actor, but as a benchmark for purification steps. Its presence marks out the degree of cleanliness in the end product. You won’t see it listed as an active ingredient in medicines or final formulations, but those who craft these products must measure and minimize its footprint. On the raw materials end, both m-cresol and ammonium sulfate serve as feedstocks. This reinforces the compound’s retrieval anywhere product streams encounter those two components under sulfonation conditions.
By international shipping standards, Policresulen Impurity 5 Ammonium Salt moves under the HS Code for sulfonic acids and their derivatives, typically falling into category 2904 or closely related subclasses. Like many aromatic sulfonates, direct contact with eyes, skin, or ingestion leaves open risk of irritation or mild toxicity, mostly stemming from both the phenolic part and the ammonium content. My time around these compounds—always with gloves, eye protection, and a well-ventilated bench—drives home that chemical hygiene is non-negotiable. SDS sheets clearly label the compound potentially harmful if mishandled, urging care not only during routine analysis but also as spills can slip into waste or enter water streams. While not explosively hazardous under normal lab or plant conditions, heat, acids, and strong oxidizers accelerate decomposition, breaking down the structure and releasing ammonia or sulfonic fumes. Emergency showers, eye-wash stations, and readily available neutralizing agents build the practical safety system here.
Reducing presence of Policresulen Impurity 5 Ammonium Salt in finished product means starting with well-refined raw materials, maintaining controlled sulfonation conditions, and investing in downstream purification. Every additional run through crystallization, chromatography, or filtration pushes purity higher but brings cost and yield trade-offs. Modern analytical tools—high performance liquid chromatography, mass spectrometry—pinpoint impurity levels with remarkable precision, letting teams catch problems before they snowball into recalls or regulatory action. At the regulatory level, adherence to guidelines from authorities like EMA, US FDA, or China’s NMPA makes the difference between global market access and rejection. The story of m-cresol-4-sulfonic acid ammonium salt sits within this broader struggle: balancing risk, discipline, and value in chemical manufacturing.
