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An authoritative white paper guide for pharmaceutical procurement managers, formulation chemists, and global B2B sourcing executives.
Benzethonium Chloride (CAS Number: 121-54-0), chemically designated as N,N-dimethyl-N-[2-[2-[4-(1,1,3,3-tetramethylbutyl)phenoxy]ethoxy]ethyl]benzene-methanaminium chloride, is a synthetic cationic quaternary ammonium compound (QAC). Exhibiting high surfactant efficacy alongside broad-spectrum microbicidal activity, it functions primarily by disrupting lipid bilayer membranes of target microorganisms.
Upon topical administration, the positively charged hydrophilic ammonium head group adsorbs onto negatively charged bacterial cell walls. This electrostatic interaction triggers structural destabilization, cytoplasmic leakage, and rapid cell lysis. It demonstrates exceptional efficacy against Gram-positive bacteria (including Staphylococcus aureus), Gram-negative pathogens, yeasts, and select enveloped viruses.
Unlike lower-chain quaternary compounds, Benzethonium Chloride offers enhanced structural stability, superior odor profile, and low volatility. Its physical profile makes it an ideal active pharmaceutical ingredient (API) and preservative in OTC topical antiseptics, liquid bandages, anti-itch ointments, and medical skin preparation wipes.
| Parameter Specification | Standard Acceptance Limit | Testing Methodology / Reference |
|---|---|---|
| Chemical Formula | C27H42CINO2 | Molecular Calculation (MW: 448.08 g/mol) |
| CAS Registry Number | 121-54-0 | Chemical Abstracts Service |
| Assay Content (Dry Basis) | 99.0% – 101.0% | Potentiometric Titration (USP/EP) |
| Appearance | White or off-white fine crystalline powder | Visual Inspection |
| Melting Point Range | 158°C – 164°C | Capillary Melting Method |
| Solubility Profile | Freely soluble in water, ethanol, and chloroform | Solubility Testing at 25°C |
| Loss on Drying | ≤ 5.0% | Thermal Gravimetric Analysis (105°C) |
| Residue on Ignition | ≤ 0.1% | Sulfated Ash Assay |
| Heavy Metals / Impurities | ≤ 10 ppm (Individual organic impurities ≤ 0.5%) | ICP-MS / High-Performance Liquid Chromatography (HPLC) |
Analysis of global shifting regulatory frameworks, replacement dynamics, and supply security for broad-spectrum topical biocides.
Following stringent global bans by the US FDA and European Chemicals Agency (ECHA) on Triclosan and Triclocarban in consumer antiseptic washes, pharmaceutical and cosmetic manufacturers rapidly adopted Benzethonium Chloride as a safe, highly compliant, non-halogenated replacement active.
Rising consumer and institutional preference for alcohol-free topical sanitizers—which avoid skin dryness, flammability hazards, and religious/workplace restrictions—has accelerated multi-ton procurement demands for high-purity Benzethonium Chloride topical solutions.
Hospitals and surgical centers require validated topical antiseptics for pre-operative patient skin preparation and wound care. Benzethonium Chloride's bio-compatibility and compatibility with non-ionic surfactants position it as a foundational chemical component.
Information Gain Insight for Sourcing Officers: When buying Benzethonium Chloride Topical raw material, verify batch-to-batch consistency of residual impurities like Free Amines and Alkyl Halides. Sub-standard industrial grades cause discoloration and loss of viscosity in premium gel formulations.
Integrating 16+ years of chemical synthesis expertise with world-class production capacity in Shandong Province.
Headquartered in the national-level Chemical Industry Park of Jinan City, Shandong Province, JIMPOCHEM CO., LTD operates a state-of-the-art chemical manufacturing complex spanning over 500 acres. By owning vertically integrated production lines for key precursors like tertiary amines and ethoxylated phenols, we mitigate upstream raw material volatility.
Our intelligent automated control systems digitalize reaction kinetics, crystallization phases, and drying workflows. This ensures consistent bulk output while allowing flexible batch sizes ranging from pilot-scale orders to multi-ton container shipments.
Operating under strict ISO 9001 quality management and ISO 14001 environmental frameworks, every single batch of Benzethonium Chloride topical grade undergoes rigorous multi-stage analytical testing. From raw material receipt to finished goods quarantine, we execute HPLC purity assays, heavy metal residue checks, and micro-bioburden screens.
Our complete batch traceability protocol empowers downstream pharma clients to instantly trace raw material origins, reaction logs, QA test certificates, and logistics parameters via unique lot numbers.
Benzethonium Chloride Topical formulations engineered for diverse international market needs.
Used widely in first-aid antiseptic sprays, wound cleansers, liquid bandages, and burn care gels. Formulated at 0.1% to 0.2% w/w under FDA OTC monograph standards to prevent skin infections in minor cuts, scrapes, and burns.
Serves as a robust broad-spectrum antimicrobial preservative in premium anti-acne cleansers, leave-on creams, deodorants, and wet wipes, protecting formulations against bacterial and fungal decay.
Essential active ingredient in hospital-grade skin disinfectant washes, pre-surgical prep swabs, anti-itch veterinary sprays, and animal wound sanitizers due to fast kill-rate and minimal tissue reactivity.
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Navigating complex international chemical and pharmaceutical import regulations seamlessly.
To assist global buyers with regulatory registration and health authority filings, JIMPOCHEM provides a complete technical documentation suite with every order:
We offer tailored packaging options ensuring product integrity during ocean and air freight transit across diverse climate zones:
Addressing key procurement queries, technical parameters, and formulation guidelines for Benzethonium Chloride Topical.
Under the US FDA OTC Tentative Final Monograph for Health Care Antiseptic Products, Benzethonium Chloride is permitted as a topical active ingredient up to a maximum concentration of 0.13% w/w for leave-on hand sanitizers and up to 0.2% w/w in specialized topical first-aid liquids and anti-itch creams. Always consult your regional cosmetic or pharmaceutical regulatory authority for localized limits.
While both are quaternary ammonium compounds, Benzethonium Chloride possesses a distinct synthetic chemical structure featuring a specific phenoxyethoxyethyl hydrophobic chain. This gives Benzethonium Chloride greater melting point stability, lower odor, and superior compatibility with select aromatic cosmetic fragrance systems compared to the multi-chain alkyl mixture found in Benzalkonium Chloride.
Being a cationic surfactant, Benzethonium Chloride is incompatible with anionic surfactants (such as Sodium Lauryl Sulfate), anionic thickeners (like Carbomer or Xanthan Gum), and strong oxidizing agents. Mixing with anionic compounds results in neutralization, precipitation, and complete loss of microbicidal activity. Non-ionic or cationic emulsifiers and cellulose-derived thickeners (e.g., HPMC) are recommended.
Benzethonium Chloride powder should be stored in original tightly sealed fiber drums in a cool, dry, well-ventilated warehouse away from direct sunlight, heat sources, and strong oxidizers. Stored properly below 25°C, it exhibits an extended shelf-life of 36 to 48 months without degradation of active purity.
Our standard MOQ for high-purity Benzethonium Chloride Topical USP grade starts at 25 kg (1 full drum). Standard manufacturing and dispatch lead time is 7 to 12 working days following order confirmation. Custom packaging or specific particle-size micronization requests are accommodated upon inquiry.
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