Ondansetron hydrochloride dihydrate, EP grade CAS 103639-04-9

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CAS: 103639-04-9

MF: C₁₈H₁₉N₃O · HCl · 2H₂O

MW: 365.85

Physical Description	White or almost white powder
Solubility	Sparingly soluble in water and in ethanol, soluble in methanol
Identification (IR)	To conform to standard
Identification	To pass test B
Impurity B	≤ 0.4% (TLC)
Related Substances (HPLC)
Impurity C	≤ 0.20%
Impurity D	≤ 0.15%
Impurities A and G	≤ 0.20%
Impurities E and F	≤ 0.20%
Any Unspecified Impurity	≤ 0.10%
Total Impurities	≤ 0.40%
Water (KF)	9.0 - 10.5 %
Sulfated Ash	≤ 0.1%
Assay (HPLC)	97.5 - 102.0 % (C18H19N3O·HCl, anhydrous basis)
Pharmacopoeia Specification(s)	EP
Specification Version	1.0

Pictograms
Signal word	Danger
Hazard statements	H301: Toxic if swallowed
Precautionary statements	P280: Wear protective gloves/protective clothing/eye protection/face protection. P301+P310: IF SWALLOWED: Immediately call a POISON CENTER/doctor/...
Supplementary EUH statements
UN Number	UN2811 - 6.1 - PG III
WGK	WGK 3
SDS Version	3.0