Clonidine hydrochloride CAS:4205-91-8 CAS NO.4205-91-8

Test Items

Specifications

Results

1. Characteristics:

A white or almost white crystalline powder,

soluble in water and in ethanol.

Pass

2. Identification:

A: Infrared Absorption<197k>
B: Ultraviolet Absorption <197U>
Analytical wavelength:272 nm
Medium: 0.01 N hydrochloric acid
Sample solution: 330 μg /mL.
Acceptance criteria:Absorptivities, calculated on the dried basis, do not differ by more than 3.0%.
C: It responds to the tests for Chloride

Pass
1.8%
Pass

3. pH:

3.5-5.5

4.7

4. Colour and clarity of solution

Clear

Pass

5. Loss on drying:

Not more than 0.5％

0.14％

6. Residue on ignition:

Not more than 0.1％

0.04％

7. Impurities:

Related compound A NMT 0.1%
2,6-Dichloroaniline NMT 0.1%
Any other unspecified impurity NMT 0.1%
Total impurities NMT 0.2%

Undetected
Undetected
0.02%
0.06%

8. Assay:

98.5％～101.0％

99.93％

9. Residual organic solvents

Ethanol NMT 5000ppm

Pass

10. Storage

Preserve in tight containers.Store at controlled room temperature.

Conclusion

Complies with the USP42