Home » Active Pharmaceuticals Ingredients » Bromhexine Hydrochloride
| Product Name | Bromhexine Hydrochloride BP/EP/USP |
| Chemical Name | N-(2-Amino-3,5-dibromobenzyl)-N-methylcyclohexanamine hydrochloride |
| CAS Number | 611-75-6 |
| Chemical Formula | C14H20Br2N2 HCL |
| Molecular Mass | 412.59 g/mol |
| Therapeutic Category | Antimucolytic |
Specification of Bromhexine Hydrochloride :
| Test | Specification |
| Characteristics | White crystalline powder |
| Solubility | Alcohol : 100 to 1000 parts Methylene Dichloride : 100 to 1000 parts Water : 1000 to 10000 parts |
| Identification | IR test : Complies with standard Thin Layer Chromatography : Complies with standard Chemical Test : Complies with test Primary Aromatic Amine Test : Complies with amine test Chloride test : Complies with chloride test |
| Appearance of solution | Complies with test |
| uv test | 208 to 211 nm |
| Related substance (HPLC) | Identified impurity : Impurity A : NMT 0.1 % Impurity B : NMT 0.1 % Impurity C : NMT 0.1 % Impurity D : NMT 0.1 % Impurity E : NMT 0.1 % Unknown impurity : Impurity 1 : NMT 0.1 % Impurity 1 : NMT 0.1 % Total impurities : Not More Than 0.3 % |
| Residual solvents | Alcohol : NMT 5000 ppm Toluene : NMT 890 ppm |
| Foreign particles | Not detected |
| Loss on drying | Not More Than : 1.0 % |
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