Ondansetron HCl CAS No 103639-04-9

• Function: Antineoplastic
• Grade Standard: Medicine Grade
• Type: API
• State: Powder
• Volatile: Not Volatile
• Standard: USP, Cp, Bp
• Model NO.: SAMREAL-0213
• Transport Package: Bag
• Specification: 1kg/bag
• Trademark: samreal
• Origin: China

Product Description

Ondansetron hcl CAS No. 103639-04-9

Items	Specifications	Results
Appearance	White or off-white crystalline powder	Qualified
Solubility	Sparingly soluble in water and in alcohol, Soluble in methanol, slightly soluble in isopropyl Alcohol conforms and dichloromethane, very slightly soluble in Acetone, in chloroform and in ethyl acetate.	Qualified
Identification
1.UV	Max 209,248,267,310nm	Qualified
2.IR spectrum	Concordant with the working reference.	Qualified
3.Discrimination chloride	Forward Reaction .	Qualified
Water	9.0-10.5%	9.7%
Residue on Ignition	≤0.1%	0.02%
Heavy metal	≤10ppm	<10ppm
Compound D	≤0.1%	0.04%
Chromatographic purity
TLC max single impurity	≤0.40%	0.11%
Other single impurity	≤0.20%	0.09%
HPLC Impurity C	≤0.20%	0.09%
Imidazole	≤0.20%	0.02%
2-methylimidazole	≤0.20%	0.02%
-Impurity A	≤0.20%	0.05%
-Other single impurity	≤0.10%	0.07%
-Total Impurity	≤0.50%	0.29%
Residual solvent
Ethanol	≤5000ppm	240ppm
Assay	98.0%~102.0% Calculates on the dried basis.	99.81%
CONCLUSION: CONFORM WITH SPECIFICATION AS PER USP40.

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Standard:USP40,CP,BP.