Test |
|
Specification |
Characters |
: |
A white crystalline powder. |
Solubility |
: |
Very soluble in water, freely soluble in alcohol, in methanol and in methylene chloride |
Identification |
: |
Test A,C and E OR Tests A,B,D and E. |
Identification A |
: |
It should comply with the test for specific optical rotation. |
Identification B ( Melting Range) |
: |
110.00C to 115.00C. |
Identification C |
: |
The Infra red absorption spectrum should concordant with the spectrum obtained from Dexchlorpheniramine Maleate working Standard. |
Identification D |
: |
The chromatogram obtained with the test solution should show two clearly separated spots. The upper spot should be similar in position and size to the spot in the chromatogram obtained with reference solution. |
Identification E |
: |
The solution should give the reaction of chlorides |
Appearance of solution |
: |
The solution should be clear and not more Intensely coloured than reference solution BY6. |
pH |
: |
4.50 to 5.50. |
Specific optical rotation |
: |
+22.000 to +23.000 on dried basis
|
Related substance (By GC ) : |
: |
Any individual impurity: Not more than 0.40%.
Total impurity: Not more than 1.00%.
|
Enantiomeric Purity ( By HPLC ) |
: |
(R) Enantiomer: Not more than 2.00%.
Any Other Individual Enantiomer: Not more than 0.50%.
|
Heavy metals |
|
Not more than 20ppm. |
Loss On Drying (At 65.00C) |
|
Not more than 0.50%w/w |
Sulfated Ash |
|
Not more than 0.100 %w/w |
Assay |
|
98.00% to 100.50% w.r.t. dried substance. |
End of specification |