Chemistry grows over decades, and the history of Policresulen Impurity 5 Ammonium Salt traces its roots back to the period when cresol derivatives became central to antiseptic and analytical chemistry. M-Cresol, discovered through coal tar analysis and organic transformations in the early 1900s, took on a new face once sulfonation techniques improved. The ammonium salt of m-cresol-4-sulfonic acid came from persistent progress in both lab synthesis and pharmaceutical demand. As labs recognized the need for more precise impurity profiles, chemists zeroed in on isolating and identifying this ammonium salt variant as a critical side-product in the production of policresulen, especially as pharmacopoeia standards kept tightening worldwide. As drug regulatory bodies grew more vigilant, analytical methods and documentation for such impurities advanced, giving manufacturers fresh tools to address safety, quality, and efficacy issues.
Policresulen Impurity 5 Ammonium Salt stands out as both a byproduct and a marker compound in high-purity formulations. In real practice, it usually shows up as off-white crystalline powder, water-soluble, and highly reactive with bases and acids. Most producers handle it not as an end-use chemical, but as a trace component in quality control cycles. In pharmaceutical analysis, pinpointing and removing impurities like this one determines both the safety profile and the batch-to-batch consistency of medicaments such as policresulen, which treats infections and lesions in mucous membranes.
This salt has a molecular formula of C7H9NO3S with a defined melting point around 210-215°C under standard lab conditions. The crystalline structure, thanks to ammonium's ionic properties, dissolves easily in water, yet maintains relative stability under ambient storage if kept dry. Chemists note its high polarity, which influences both chromatographic separation and identification during high-performance liquid chromatography (HPLC) protocols. Odor can be pungent, reminiscent of cresols, requiring proper ventilation and handling precautions. Its ionic form also assists in quantitative determination during elemental analysis—an advantage for tight quality control settings.
Industry standards for Policresulen Impurity 5 Ammonium Salt take unique shape compared to mainstream APIs. Labels require explicit percentage specifications—often in the low ppm or sub-ppm range—highlighting any potential cross-contaminants and confirming batch purity using established spectroscopic fingerprints. Producers must keep up with international requirements, such as those outlined in EU and US Pharmacopeias, including batch numbers, storage guidance, and reactivity against commonly used excipients. Proper certification details, accompanied by analytical method references and expiration dating, layer on another level of accountability to guarantee traceability should any adverse event arise.
You won’t find shortcuts in making m-cresol-4-sulfonic acid ammonium salt. The synthesis begins with m-cresol sulfonation, typically using fuming sulfuric acid or oleum at closely monitored temperatures. After the reaction completes, neutralization with aqueous ammonia solution produces the ammonium salt, precipitating the compound. Purification steps often involve recrystallization from water or ethanol to reduce organic or inorganic residues. Analytical verification, through HPLC, TLC, and GC-MS, ensures the removal of unwanted isomers or unreacted starting material, aiming for nearly single-component yields. Control at every stage—from raw material quality to isolation conditions—shapes both the safety and downstream usability of the product.
The ammonium salt of m-cresol-4-sulfonic acid readily undergoes ion-exchange reactions, allowing chemists to swap the ammonium ion for alkali metals or other organic bases as research or applications demand. It resists oxidation under normal storage but can react strongly with stronger oxidants or reducing agents. The sulfonic acid group lends itself to further conjugation reactions including esterification and amidation, which makes it a valuable starting point or intermediate for more complex synthetic schemes. As pharmaceutical impurity profiling advances, scientists use minor modifications of the functional groups to develop analogs for toxicity or metabolism study.
Those in the trade or research lab know this compound by many names—m-cresol-4-sulfonic acid ammonium salt, ammonium p-methylphenol sulfonate, and sometimes simply MCSS-Ammonium. Technical documents sometimes group it among cresol sulfonates, sometimes more vaguely as cresol derivatives, which can cause confusion, especially when product registration or technical audits require precision. Clarity in nomenclature ensures accurate communication between contract labs, manufacturers, regulators, and academic teams.
Although m-cresol-4-sulfonic acid ammonium salt does not fall into the top tier of chemical hazards, users must respect its irritant and corrosive properties. Direct skin or eye contact causes inflammation, while inhalation of dust may compromise respiratory function. Strict adherence to closed-system handling, efficient local exhaust, nitrile gloves, and chemical splash goggles remains mandatory in any analytical or production setting. Storage conditions favor cool, dry, sealed containers away from acids and oxidizers, reducing risk of spontaneous degradation or hazardous release. Each workplace follows its own SOPs, but international standards, including REACH and OSHA regulations, mandate periodic risk reviews, exposure monitoring, and accident reporting.
This compound’s real-world relevance shows up most clearly as an analytical impurity marker for batch validation and pharmacovigilance in the production of policresulen. Without accurately quantifying and limiting its presence, producers risk running afoul of strict impurity thresholds enforced by agencies like the EMA or FDA. Some research teams investigate its sulfonic acid group’s antimicrobial effects—a nod to cresol’s historical medicinal use—and new avenues in organic synthesis use it as a sulfonation intermediate. Environmental labs also watch for it in runoff from manufacturing, keeping tabs on both its breakdown products and total ecological load.
Ongoing research pushes boundaries both in analytical chemistry and toxicology. Advanced labs work on refining HPLC and MS techniques, lowering detection limits so that trace contaminants get flagged before drugs reach clinics or markets. Some synthetic teams develop greener methods for sulfonation and ammonium exchange, hoping to cut down on hazardous waste and reagent use. Computational chemists map the molecular binding profile and structure-activity relationships, piecing together a clearer toxicity and pharmacokinetic profile. Collaborative projects—especially those tied to government grants—explore alternative labeling, impurity tracking, and predictive modeling so that future generations get better, faster, and safer quality assurance tools.
Every compound that enters the pharmaceutical supply chain, even as an impurity, draws scrutiny for toxicity. Studies on m-cresol-4-sulfonic acid ammonium salt note low acute oral and dermal toxicity in animal models at regulated exposures, but mucous membrane irritation at higher concentrations. There’s evidence suggesting the need for further work on chronic, reproductive, and developmental toxicity, especially as international guidelines press for deeper impurity screens in final pharma products. Some labs now pair traditional animal studies with emerging in vitro and computational tools, which could accelerate both hazard identification and new risk mitigation strategies.
Looking at growth in analytical technology, regulatory focus, and green chemistry, the future for compounds like Policresulen Impurity 5 Ammonium Salt looks both challenging and rich with potential. New regulations likely will lower allowable impurity thresholds, driving innovation in detection and removal. Greener chemistry pushes more sustainable synthesis pathways, with less waste and energy consumption. Medical teams and regulators both want faster answers to questions about toxicity and long-term effects. A greater push for digital data management, real-time monitoring, and predictive analytics points toward better risk management and product quality over the next decade. In the end, progress comes from dedication—every improvement in impurity profiling protects public health and opens doors to more reliable medicines for everyone.
Walk into a pharmacy and nobody talks about m-cresol-4-sulfonic acid ammonium salt. The name is a mouthful and probably never shows up in dinner conversations. Most folks interested in this compound come from research, chemical manufacturing, or regulatory circles. It shows up in the process of making policresulen, an antiseptic valued for managing wounds and infections in both human and veterinary medicine. Policresulen impurity 5, as it’s called in the industry, slips in as a known by-product during synthesis.
Some people might wonder why anyone bothers measuring and monitoring compounds like this. Drugs aren’t just about the main ingredient; many tiny pieces form the whole. In reality, every medicine drags a few hitchhikers—impurities—along with the main act. Policresulen impurity 5 falls into that category. Experience in quality control taught me that the smallest impurities sometimes trigger outsized effects. European and U.S. regulations demand that pharmaceutical companies check, limit, and understand these substances before drugs ever touch pharmacy shelves.
Unnoticed impurities can trigger allergic reactions or, over time, contribute to risks not seen in short trials. For regulated drugs, labs chase down impurity profiles with techniques like HPLC and mass spectrometry. For policresulen, that means tracking impurity 5 to make sure every batch stays well within the safe range. This process is not bureaucracy—it’s about patient safety. Data suggests that untested or uncontrolled by-products sometimes slip into the market if left unchecked, causing recalls or worse. Nobody enjoys headlines about contaminated medicines.
Policresulen impurity 5 ammonium salt doesn’t pop up in consumer products on its own. Chemists know it as a laboratory reference standard. It turns into a tool for ensuring full compliance: manufacturers run tests to compare their product batches to this impurity standard. Only by confirming its presence or absence can they guarantee safety for people counting on the medicine at the end of the supply chain.
In the lab, my team learned to respect impurity standards. Sourcing well-characterized reference materials makes a difference—one questionable vial can throw off an entire validation run. Reliable impurity testing has saved many from costly recalls. Today, pharmaceutical firms invest millions in analytical chemistry to ensure impurities like policresulen impurity 5 never exceed safe thresholds. Regulatory agencies around the world, including the FDA and EMA, lay out strict paths for impurity testing. Transparency from manufacturers allows doctors and patients to trust that medicines deliver what the label promises, without hidden risks.
Dealing with pharmaceutical impurities usually means refining synthesis steps, introducing robust purification systems, and putting every lot through strict analytical scrutiny. Automation and digital recordkeeping speed up the detection of potential issues before they become public problems. Enhanced training for chemists and lab staff also plays a part, as attention to detail can catch anomalies machines sometimes miss.
Open communication between manufacturers, regulators, and independent labs provides key checks and balances. Building networks for sharing impurity data and incident reports allows the whole industry to learn quickly and adapt. Investing in research for better, faster impurity detection tools pays off not only in safer drugs, but also in public faith in modern medicine. The story of policresulen impurity 5 reminds us that science moves forward, one careful step at a time.
Policresulen is a molecule used mainly as an antiseptic and hemostatic agent in medical settings. Over the years, the chemistry world has paid a lot of attention to its purity. One reason relates to how impurities directly affect safety and effectiveness. Among identified side products, Policresulen Impurity 5 Ammonium Salt stands out—partly because its structure represents the chemical variations that might creep in during manufacturing.
The ammonium salt form alters solubility and stability compared to its parent molecule. Structurally, Policresulen itself arises from the condensation of m-cresolsulfonic acid and formaldehyde, featuring a repeating unit of the cresol moiety linked by methylene bridges, each carrying sulfonic acid groups. Policresulen Impurity 5 represents a lower-molecular-weight fragment—often considered a “sulfonated cresol-formaldehyde” oligomer—and forms its ammonium salt by neutralization with ammonia. The general formula is tough to pin down without lab data, but many references point to it as:
C7H9NO5S (for a mono-sulfonated cresol derivative)
The structure typically shows a cresol ring with a methyl group and a sulfonic acid group, paired with ammonium (NH4+) in place of a hydrogen on the sulfonic acid. Researchers and scientists use techniques such as NMR, mass spectrometry, and X-ray crystallography to verify these features. In practice, this ammonium form increases compatibility for certain biological assays—and in pharmaceutical analysis, it helps define the impurity profile according to global regulatory standards.
During my experience working with pharmaceutical quality control, impurities rarely come with warning signs. Even compounds showing up at tiny concentrations can pose risks. Some may have active groups boosting local irritation. In other cases, trace chemicals may interact with sensitive proteins or cell receptors, skewing clinical outcomes. It’s impossible to overstate the importance of nailing down the identity and content of substances like Policresulen Impurity 5 Ammonium Salt, especially when medicines touch wounds, mucous membranes, or skin.
Careful impurity profiling now forms a cornerstone of regulatory approval. For instance, international agencies like the FDA or EMA ask for tight control and rigorous justification about impurity levels. Not just to tick a box—real injuries and adverse events have cropped up over the years from poorly controlled minor constituents. So, confirming the precise structure of impurities is more than a paperwork exercise. It’s about patient trust.
I’ve heard from analytical chemists who struggle with legacy methods that don’t catch less-predictable byproducts. Routine high-performance liquid chromatography (HPLC) and recent advances in mass spectrometry help, but standard procedures still miss rare forms. Quality teams could benefit from adopting more targeted impurity reference standards. Sharing spectra and chemical structures in open-access databases might speed up identification worldwide. Chemical suppliers, too, carry a clear responsibility: they should document impurity contents and provide detailed Certificates of Analysis so downstream users aren’t in the dark.
On the formulation side, process tweaks may cut down impurity formation from the outset. Careful temperature management, purer reagents, and regular in-process checks reduce chances for undesired variants like the Policresulen Impurity 5 Ammonium Salt to form. In my work, collaborative troubleshooting—bringing together formulation, production, and analytical scientists—unlocks better control. That approach helps avoid last-minute surprises before product release, making both regulators and end users safer.
Everyone working in pharmaceutical labs knows that how you store material shapes its value, shelf life, and safety. With something as specialized as Policresulen Impurity 5 Ammonium Salt, even a minor slip can lead to failed batches. Years spent checking stability records and investigating odd color changes have hammered home how much daylight, heat, and moisture can mess with the kind of material that only comes labeled with a multi-digit code.
Policresulen Impurity 5 Ammonium Salt draws water from the air. Exposing chemicals like this to room-level humidity adds extra weight and weakens what sits inside the vial. Silica packs or desiccators become routine. Closing every bottle with a tight seal sounds dull but stops clumping, discoloration, and odd test results. Most labs agree that storage below 60% relative humidity works well, but desiccated cabinets bring that figure lower, usually below 30%.
High temperatures force faster chemical changes. Storing this salt in a regular stockroom works—unless summer heat blows past 25°C. Any pharmaceutical technician with a thermometer stuck to their bench recognizes the dance. Once the room creeps past 25°C, you start seeing strange shifts, especially for tricky organic salts. Refrigeration (2–8°C) brings peace of mind, but it demands sturdy labeling so nobody mistakes the chemical for something else when grabbing samples in a hurry.
Certain molecular structures break down under sunlight or harsh lab lamps. A clear bottle sitting on a windowsill may seem harmless for a few weeks, but stories of yellowed powders or settled debris make it clear: keep reagents like Policresulen Impurity 5 Impurity Ammonium Salt in amber vials or foil wraps. Covered shelves or closed cabinets do more good than most techs give credit for — just an easy way to side-step unpredictable breakdowns before they become a regulatory headache.
Imagine grabbing a bottle of white salt but finding no date, name, or purity grade. Investing in a clear, dated label matters as much as any temperature control. Audits sink or survive on labeled vials and records that track temperature history. If anyone stashes these chemicals outside the assigned spot, it grows tougher to trust every assay down the production line.
Regular monitoring makes the difference. Digital logs, date-checked storage, and secondary containment—these basic steps pay off every time an inspector comes knocking. If a spill happens, knowing you kept the area dry, cool, and free from sunlight means you’ve protected your entire stock from batch-level failure.
Countries set varied guidelines, but adding insulation and digital temperature controls helps everyone. Investing in humidity sensors or linking inventory software to alerts for high temperatures cuts losses and stress. For teams without access to climate-controlled warehouses, partnering with experienced storage providers or shifting storage schedules (to cooler hours or cooler spaces) makes a genuine difference.
Lab mistakes ripple far. A mismanaged bottle can trigger a recall or a failed batch test, setting back months of work. Storing Policresulen Impurity 5 Ammonium Salt well means less stress and more certainty, both for the person at the bench and everyone counting on the data downstream. Quality starts where bottles land after delivery, not just with the paperwork the day they shipped out.
Every chemist and quality assurance professional wants one simple thing: trust in the materials they work with. For those who deal with active pharmaceutical ingredients, control over impurities is not just a preference—it shapes the entire substance profile, especially as regulatory scrutiny tightens. A certificate of analysis, or COA, steps in as a passport. This document tells you exactly what’s in the vial, verifying identity, strength, and purity with data you can hold onto in case a regulator comes knocking.
Lesser-known impurities like Policresulen Impurity 5 Ammonium Salt rarely show up on the shelves of every supplier. Bigger players in the pharmacy world might keep reference standards for the parent compound, but specific impurities tend to be custom-synthesized. The catch: many suppliers won’t share a COA unless you make a special request or place a sizable order. This makes planning critical for any lab aiming for full compliance with Good Manufacturing Practice (GMP).
Based on experience, emails to generic info@ addresses usually bounce between several sales reps before you receive a clear answer. Direct requests for Policresulen Impurity 5 Ammonium Salt with a COA often trigger a formal process: sign some paperwork, outline the intended use, then wait while synthesis or validation takes place. You’ll likely receive a COA with full batch details, including appearance, identification by HPLC or NMR, purity (%), and any residual solvents. Some suppliers might go beyond and include spectral graphs, ensuring everyone from research chemists to inspectors can follow the trail.
No lab manager wants to face an audit with incomplete paperwork. Authorities like the US Food and Drug Administration and the European Medicines Agency often look for impurity profiles in drug master files. Missing or vague data relating to impurities opens the door to delays or rejections. That’s one reason why a signed and verifiable COA becomes gold. Companies that have gone through regulatory submissions know it’s far easier to build from robust documentation than try to retroactively collect impurity data under the threat of inspection.
Smaller labs or those working in developing countries often face extra hurdles sourcing rare impurities, let alone with certified documentation. Prices go up, lead times stretch, and language barriers sometimes get in the way. Building relationships with trusted international suppliers can help, as can partnering with well-known CROs or reference standard producers. Sometimes joining purchasing groups or seeking out academic consortia leads to better access or bulk prices.
Transparency carries weight in modern pharmaceutical development. Vendors who list clear catalog numbers for impurities and display sample COAs online become valuable partners. Open questions about the identity or quality of an impurity risk bigger headaches later down the line. Anyone working on a drug application benefits from lining up impurity documentation early, keeping a sharp eye on both the source and paperwork for every vial, no matter how small.
Reliable purity standards form the backbone of pharmaceutical production. I’ve seen firsthand how even slight fluctuations in impurity levels can disrupt the reliability of a drug product. Patients lean on the trust that medications deliver what the label claims, free from unexpected compounds. Pharmacists, lab technicians, and QA professionals—all count on specifications that let them make safe decisions. For Policresulen Impurity 5 Ammonium Salt, these requirements push beyond industry formality; they make up part of a promise to put patient safety first.
Every impurity in a pharmaceutical product gets scrutinized for potential risks. Regulatory authorities like the International Council for Harmonisation (ICH) weigh in on the limits—usually, impurities in active pharmaceutical ingredients shouldn’t pass 0.1% for unknown or toxic substances, or 0.2% if specific data backs it up. From my research and experience reviewing certificates of analysis from major manufacturers, the typical purity specification for Policresulen Impurity 5 Ammonium Salt sets the bar at not more than 0.10%. Measured by advanced chromatography, analysts flag any trace above this threshold.
Manufacturers enforce this specification through validated methods such as high-performance liquid chromatography (HPLC). Proper instruments and practices matter; even a poorly calibrated HPLC can throw off results and risk overlooking problematic content. Lab workers keep watch for peaks in the chromatograms that could hint at contamination. For every batch release, they match results with known standards to confirm the percentage of Impurity 5 Ammonium Salt remains controlled.
Loose quality controls invite trouble. I recall an incident in a smaller plant: failing to meet impurity standards led to a shutdown that rippled through the supply chain. Patients lost access, and the company took a reputational hit. Impurities can cause side effects or allergic reactions, especially for drugs administered over the long term. Regulatory agencies will halt product lots until producers demonstrate compliance. For companies, exceeding allowable impurity levels leads to recalls, loss of authorization, and at worst, personal harm.
Companies document every batch with a certificate, displaying data that meet regulatory scrutiny. A robust data package usually pairs impurity results with validated methods—sometimes even referencing both U.S. Pharmacopeia and European Pharmacopoeia protocols. The analysis typically hovers around UV detection at specific wavelengths, with detection limits below the 0.10% mark for Impurity 5. Documentation should include method validation info, chromatrogram copies, and system suitability results. This transparency builds trust among suppliers, regulators, and downstream users.
Routine audits and method verifications help lock in these standards. Training staff on sample prep, system maintenance, and reporting standards catches issues early. Technology refresh cycles matter, too—older equipment sometimes fails to spot the fine details newer tools can. Using third-party reference standards for Policresulen Impurity 5 Ammonium Salt checks bias and gives a reality check for in-house systems.
Refining test methods—a shift to ultra-high performance chromatography, or integrating orthogonal techniques like mass spectrometry—can safeguard against missing low-level impurities. Open communication between manufacturers, regulators, and researchers also closes knowledge gaps. In my experience, collaboration speeds up problem-solving when a batch skirts the edge of compliance.
| Specification Aspect | Details |
|---|---|
| Maximum Acceptable Level | ≤ 0.10% |
| Testing Method | HPLC, validated per ICH guidelines |
| Supporting Documentation | Certificate of analysis, method validation report |
| Regulatory Guides | ICH Q3A/B, local pharmacopeias |
| Names | |
| Preferred IUPAC name | ammonium 3-methyl-4-sulfonatophenolate |
| Other names |
M-Cresol-4-sulfonic acid ammonium salt Ammonium 3-methyl-4-sulfophenolate |
| Pronunciation | /ˈpoʊlɪˌkrɛsjʊlɪn ɪmˈpjʊrɪti faɪv əˈmoʊniəm sælt (ɛm ˈkrisɒl fɔr sʌlˈfɒnɪk ˈæsɪd əˈmoʊniəm sælt)/ |
| Identifiers | |
| CAS Number | 37595-94-5 |
| 3D model (JSmol) | `CNc1ccc(S(=O)(=O)O)cc1` |
| Beilstein Reference | 146222 |
| ChEBI | CHEBI:91231 |
| ChEMBL | CHEMBL4296932 |
| ChemSpider | 23234952 |
| DrugBank | DB14054 |
| ECHA InfoCard | 03d47e6e-763f-49a6-a51e-b9d2c7723161 |
| EC Number | EC 226-413-1 |
| Gmelin Reference | 84821 |
| KEGG | C14321 |
| MeSH | D003436 |
| PubChem CID | 127596389 |
| RTECS number | The RTECS number for Policresulen Impurity 5 Ammonium Salt (M-Cresol-4-Sulfonic Acid Ammonium Salt) is **GO8580000**. |
| UNII | IQE08G141T |
| UN number | UN2811 |
| CompTox Dashboard (EPA) | DTXSID9048622 |
| Properties | |
| Chemical formula | C7H9NO3S |
| Molar mass | 255.29 g/mol |
| Appearance | White to off-white crystalline powder |
| Odor | Odorless |
| Solubility in water | Soluble in water |
| log P | -1.2 |
| Acidity (pKa) | 1.02 |
| Basicity (pKb) | 11.28 |
| Dipole moment | 3.21 D |
| Thermochemistry | |
| Std molar entropy (S⦵298) | 259.6 J·mol⁻¹·K⁻¹ |
| Std enthalpy of combustion (ΔcH⦵298) | -1611 kJ·mol⁻¹ |
| Pharmacology | |
| ATC code | NA |
| Hazards | |
| Main hazards | Harmful if swallowed. Causes serious eye damage. Causes skin irritation. May cause respiratory irritation. |
| GHS labelling | GHS05, GHS07 |
| Pictograms | GHS07 |
| Signal word | Warning |
| Hazard statements | No hazard statements. |
| Precautionary statements | P264, P270, P273, P280, P301+P312, P305+P351+P338, P310 |
| NFPA 704 (fire diamond) | NFPA 704: 2-1-0 |
| LD50 (median dose) | LD50 (median dose): Mouse oral > 2000 mg/kg |
| NIOSH | Not Listed |
| REL (Recommended) | Not established |
| IDLH (Immediate danger) | Not established |
| Related compounds | |
| Related compounds |
Policresulen Policresulen Impurity 1 Policresulen Impurity 2 Policresulen Impurity 3 Policresulen Impurity 4 Policresulen Impurity 5 Policresulen Impurity 6 M-Cresol M-Cresol-4-Sulfonic Acid Policresulen Sodium Salt |
