A quaternary ammonium cationic surfactant with broad-spectrum antimicrobial activity against bacteria, fungi and enveloped viruses. The most widely used preservative in multi-dose ophthalmic and nasal formulations, supplied as powder or as a ready-to-use 50% solution.
季铵盐类阳离子表面活性剂，对细菌、真菌及包膜病毒具广谱抗菌活性。多剂量滴眼剂与鼻用制剂中最常用的抑菌剂，可提供粉末或即用型 50% 溶液。
| Chemical name化学名称 | Benzalkonium Chloride (BKC)苯扎氯铵（BKC） |
| Alias别名 | Alkylbenzyldimethylammonium chloride (ADBAC)烷基二甲基苄基氯化铵（ADBAC） |
| CAS No. | 8001-54-5 |
| Function功能 | Quaternary ammonium cationic surfactant; broad-spectrum antimicrobial activity against bacteria, fungi and enveloped viruses. Available in both excipient and API grades. 季铵盐类阳离子表面活性剂，对细菌、真菌与包膜病毒具广谱抗菌活性。可提供辅料级与原料药级。 |
| Appearance性状 | White to yellowish-white powder or gelatinous fragments; also supplied as a 50% solution白色至类黄白色粉末或胶状碎块；亦可提供 50% 溶液 |
| Solubility溶解性 | Freely soluble in water, ethanol and acetone易溶于水、乙醇与丙酮 |
| Standards质量标准 | Compliant with current EP / USP / JP / ChP符合现行 EP / USP / JP / ChP |
Preservative in multi-dose ophthalmic solutions, including preserved and preservative-free-on-demand packaging systems.
用于多剂量滴眼液的抑菌防腐，包括常规多剂量包装体系。
Preservative in nasal sprays and ear drops, including systemic nasal formulations where a well-characterised preservative is required.
用于鼻喷剂与滴耳剂的抑菌防腐，适用于需要成熟抑菌剂体系的鼻用制剂。
Preservative in small-volume injectables at approximately 0.01%. API grade for antiseptic and disinfectant products.
作为小容量注射剂抑菌剂，用量约 0.01%。原料药级可用于消毒防腐类产品。
Excipient and API grades available. Choose the form that fits your process; the specification does not change.
辅料级与原料药级均可供应。按工艺选择形态，质量标准一致。
| Supply form供应形态 | Key characteristics关键特性 | Compliance符合标准 |
|---|---|---|
| BKC Powder | White to yellowish-white powder or gelatinous fragments. Hygroscopic — store in tight containers, protected from light. 白色至类黄白色粉末或胶状碎块。具吸湿性，需密闭避光保存。 | EP / USP / JP / ChP |
| BKC 50% solution溶液 | Clear, colourless to slightly yellow aqueous solution. Ready-to-use concentrate for easier handling and accurate dosing. 澄清、无色至微黄色水溶液。即用型浓缩液，便于操作与准确计量。 | EP / USP / JP / ChP |
| BKC custom solution定制溶液 | Prepared to the customer's solution specification. 按客户指定的溶液规格配制。 | Complies with customer requirement符合客户要求 |
CoA and batch-to-batch consistency data are provided with every shipment. Powder and 50% solution are supplied under one quality standard.
每批随货提供 CoA 与批间一致性数据。粉末与 50% 溶液执行同一质量标准。
The manufacturer is registered with NMPA.
生产企业已在 NMPA 完成注册。
DMF can be supported according to your target market and route of administration.
可根据目标市场与给药途径提供相应 DMF 支持。
Site audit welcomed; written supplier questionnaire available first.
欢迎现场审计；可先提供书面供应商问卷。
Complete regulatory documentation set, including safety, impurity and compendial statements.
完整法规文件包，含安全性、杂质与药典符合性声明。
Tell us the dosage form, the preservative level and the market. We will confirm the grade, the supply form and the documents you need for the filing.
把剂型、抑菌剂用量与目标市场告诉我们，我们会确认型号、供应形态与注册所需文件。
