CAS:24868-20-0 Dantrolene Sodium USP/BP

Dantrolene Sodium

CAS:24868-20-0

Purity:99%

ITEMS	SPECIFICATION		RESULTS
Assay	90.0-96.0% of C14H10N4O5 on the anhydrous basis		93.0%
Appearance	Fine orange to orange-brown powder		Conforms
Solubility	Sparingly soluble in dimethylformamide and in glycerine,sparingly soluble to practically insoluble in acetone.		Conforms
Identification A	The IR absorption spectrum exhibits maxima only at the same wavelengths as that of the Reference Standard<USP197K>		Conforms
Identification B	The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation.as obtained in the Assay.		Conforms
Identification C	Meets the requirements of the flame test for Sodium<USP191>		Conforms
Identification D	Meets the requirements for Part 1, Part 2, Part 3, Part 4.		Conforms
Related Substance	Related Compound A	0.15%(max)	N/D
	Related Compound B	0.50%(max)	0.18%
	Related Compound C	0.30%(max)	0.03%
Residual solvents  （ in-house ）	Ethanol	2000ppm(max)	235ppm
	Methanol	2000ppm(max)	N/D
	Acetone	2000ppm(max)	50ppm
	DMF	620ppm(max)	N/D
Water	14.5% to 17%		15.8%
Heavy metals(In-house)	0.002% (max)		<0.002%
Particle size	PSD 90% less than 50 um		Conforms
Storage	Preserve in tight,light-resistant containers.Store at room temperature
Conclusion: Complies with Standard.

 

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