AMBROXOL HYDROCHLORIDE MUCOSOLVAN AMBROXOLHYDROCLORIDE
AMBROXOL HYDROCHLORIDE
MUCOSOLVAN; TRANS-4-((2-AMINO-3,5-DIBROMOBENZYL)AMINO)CYCLOHEXANOL, HCL; TRANS-4-[[(2-AMINO-3,5-DIBROMOPHENYL)METHYL]AMINO]CYCLOHEXANOL MONOHYDROCHLORIDE; 2-AMINO-3,5-DIBROMO-N-[TRANS-4-HYDROXYCYCLOHEXYL]BENZYLAMINE HYDROCHLORIDE; AMBROXOL HCL; AMBROXOLHYDROCHLORIDE(EP2001/CP2000); AMBROXOLHYDROCLORIDE; trans-4-[[(2-amino-3,5-dibromo-phenyl)methyl]amino]-cyclohexanol hydrochloride; 4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride (1:1); N-(2-amino-3,5-dibromobenzyl)-4-hydroxycyclohexanaminium; trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride
Items |
Standard |
---|---|
Appearance |
White or yellowish crystalline powder |
Solubility |
Sparingly soluble in water, soluble in methanol, practically insoluble in methylene chloride |
Identification: First identification B,D Second identification A,C,D |
A. Ultraviolet and visible absorption spectrophotmetry: Absorption at 245-31 Onm B. Infrared absorption spectrophotometry: Should comply with ambroxol hcl CRS C. Thin-layer chromatography D.Chlorides test |
Clarity |
The solution must be clear |
Chromaticity |
Not more intensely colored than the reference solution Y6 |
PH |
4.5-6.0 |
Related substances(HPLC) |
Unspecified impuritied ≤0.10% Total impurity ≤0.3% |
Heavy metals |
≤20ppm |
Loss on drying |
≤0.5% |
Sulphated ash |
≤0.5% |
Residual solvents |
Methanol≤3000ppm Acetone≤5000ppm |
Microbiological |
Total aerobie counts <1000cfu/g Total fungi<100cfu/g E-coli: should be absent |
Assay(on dried basis) |
99.0%-101.0% |
Package and storage |
Double PE bag placed in plastic to carton drum. In dry protected from light place under, temperature. |
AMBROXOL HYDROCHLORIDE
MUCOSOLVAN; TRANS-4-((2-AMINO-3,5-DIBROMOBENZYL)AMINO)CYCLOHEXANOL, HCL; TRANS-4-[[(2-AMINO-3,5-DIBROMOPHENYL)METHYL]AMINO]CYCLOHEXANOL MONOHYDROCHLORIDE; 2-AMINO-3,5-DIBROMO-N-[TRANS-4-HYDROXYCYCLOHEXYL]BENZYLAMINE HYDROCHLORIDE; AMBROXOL HCL; AMBROXOLHYDROCHLORIDE(EP2001/CP2000); AMBROXOLHYDROCLORIDE; trans-4-[[(2-amino-3,5-dibromo-phenyl)methyl]amino]-cyclohexanol hydrochloride; 4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride (1:1); N-(2-amino-3,5-dibromobenzyl)-4-hydroxycyclohexanaminium; trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride
Items |
Standard |
---|---|
Appearance |
White or yellowish crystalline powder |
Solubility |
Sparingly soluble in water, soluble in methanol, practically insoluble in methylene chloride |
Identification: First identification B,D Second identification A,C,D |
A. Ultraviolet and visible absorption spectrophotmetry: Absorption at 245-31 Onm B. Infrared absorption spectrophotometry: Should comply with ambroxol hcl CRS C. Thin-layer chromatography D.Chlorides test |
Clarity |
The solution must be clear |
Chromaticity |
Not more intensely colored than the reference solution Y6 |
PH |
4.5-6.0 |
Related substances(HPLC) |
Unspecified impuritied ≤0.10% Total impurity ≤0.3% |
Heavy metals |
≤20ppm |
Loss on drying |
≤0.5% |
Sulphated ash |
≤0.5% |
Residual solvents |
Methanol≤3000ppm Acetone≤5000ppm |
Microbiological |
Total aerobie counts <1000cfu/g Total fungi<100cfu/g E-coli: should be absent |
Assay(on dried basis) |
99.0%-101.0% |
Package and storage |
Double PE bag placed in plastic to carton drum. In dry protected from light place under, temperature. |
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