Dantrolene الصوديوم CAS: 24868-20-0

ITEMS

SPECIFICATION

RESULTS

Assay

90.0-96.0% of C14H10N4O5 on the anhydrous basis

92.7%

Appearance

Fine orange to orange-brown powder

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

Related Subatance

Related Compound A

0.15%(max)

N/D

Related Compound B

0.50%(max)

0.16%

Related Compound C

0.30%(max)

0.02%

Residual solvents （ in-house ）

Ethanol

2000ppm(max)

241ppm

Methanol

2000ppm(max)

N/D

Acetone

2000ppm(max)

56ppm

DMF

620ppm(max)

N/D

Water

14.5% to 17%

16.0%

Heavy metals(In-house)

0.002% (max)

<0.002%

Storage

Preserve in tight,light-resistant containers.Store at room temperature

Conclusion: Complies with Standard.