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Best China Ondansetron hydrochloride丨CAS 103639-04-9
Ondansetron hydrochloride (CAS 103639-04-9) is the hydrochloride salt of ondansetron, a selective serotonin (5-HT₃) receptor antagonist widely used in pharmaceutical development. It is an important active pharmaceutical ingredient and research compound valued for its high purity and well-established therapeutic profile.
Specifications
| Grade | USP42 |
| Appearance | White or off-white crystalline powder |
| Solubility | Sparingly soluble in water and alcohol; soluble in methanol; slightly soluble in isopropyl alcohol, dichloromethane; very slightly soluble in acetone, chloroform, and ethyl acetate |
| Identification - UV | Maximum absorption at 209, 248, 267, and 310 nm |
| Identification - IR Spectrum | Concordant with the working reference |
| Discrimination Chloride | Forward Reaction |
| Water | 9.0%–10.5% |
| Residue on Ignition | ≤0.1% |
| Heavy Metals | ≤10 ppm |
| Compound D | ≤0.1% |
| Chromatographic Purity - TLC Maximum Single Impurity | ≤0.40% |
| Chromatographic Purity - Other Single Impurity | ≤0.20% |
| HPLC Impurity C | ≤0.20% |
| Imidazole | ≤0.20% |
| 2-Methylimidazole | ≤0.20% |
| Impurity A | ≤0.20% |
| Other Single Impurity | ≤0.10% |
| Total Impurity | ≤0.50% |
| Residual Solvent - Ethanol | ≤5000 ppm |
| Endotoxin | ≤5.8 EU/mg |
| Microbial Limits - Total Microbial Count | ≤100 CFU/g |
| Microbial Limits - Total Fungal Count | ≤50 CFU/g |
| Pathogens | E. Coli, Salmonella, Pseudomonas, Staphylococcus aureus shall be absent |
| Assay (Calculated on the Dried Basis) | 98%–102% |
Chemical Identifiers
| InChI | InChI=1S/C18H19N3O.ClH.2H2O/c1-12-19-9-10-21(12)11-13-7-8-16-17(18(13)22)14-5-3-4-6-15(14)20(16)2;;;/h3-6,9-10,13H,7-8,11H2,1-2H3;1H;2*1H2 |
| InChI Key | VRSLTNZJOUZKLX-UHFFFAOYSA-N |
| Smiles | CC1=NC=CN1CC2CCC3=C(C2=O)C4=CC=CC=C4N3C.O.O.Cl |
| EC No. | 600-465-5 |
| MDL No. | MFCD00374371 |
| PubChem CID | 59774 |
Applications
Pharmaceutical Industry
Drug Development & Formulation
Analytical & Quality Control
Serves as a reference standard for method development, impurity analysis, and quality control in pharmaceutical manufacturing.
Research & Laboratory Applications
