Dihydralazine Sulphate Hydrated BP/EP [CAS # 7327-87-9]  

Specification No. : MDX/FP/10
Supersedes : NIL
Issued Date : APR'2006
Next Review Date : MAR'2008

CAS No : [7327-87-9]
Chemical Formula : C8H10N6,H2SO4.5H2O
Molecular Weight  : 333.3
Therapeutic Category : Vasodilator.
Packing : 25.0 kg in HDPE Drum.
Storage : Store in Tightly closed

Protocols to be carried out:

SR. No. Test Limit [As per BP/EP]
1 Appearance A white or slightly yellow, crystalline powder.
2 Solubility Slightly soluble in water, practically insoluble in ethanol. It dissolves in dilute mineral acids.
3 Identification A [IR Identification] & B
4 Appearance of solution By Reference solution BY6.
5 Related Substances [By HPLC] Impurity A : Not more than 2.0 %.
Individual Impurity : Not more than 0.1 %.
Total Impurity : Not more than 0.5 %.
6 Hydrazine [By HPLC] Not more than 10 ppm.
7 Iron Not more than :20 ppm.
8 Loss On Drying Between : 13.0 % & 15.0 %.
9 Sulphated Ash Not more than : 0.1 %.
10 Assay Between : 98.0 % & 102.0 %. Of C8H10N6,H2SO4.5H2O


For further inquiery for this products contact :

M/S. MEDINEX LABORATORIES PVT. LTD.
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Mumbai- 400 102.
INDIA.
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