Specification Certificate

Name of the product : Haloperidol BP

Sr.no Test Specification
1 Description White or almost white powder.
Practically insoluble in water, slightly soluble in
ethanol (96%) in methanol and in Methylene
2 Solubility chloride.
Identification
a) Melting Point a) 150 ° c to 153° c.
b) Examine by IR Spectrophotometry
comparing with the spectrum obtained
with haloperidol CRS Examine the
3 b) IR substances prepared as discs.
c) TLC c) TLC as per BP.
d) A violet color is produced and become
d) Color test brownish and red after 20 min.
e) The solution gives reaction (a) of
e) Chloride test chlorides.
The solution is clear and not more intensely
4 Appearance of solution colored than reference solution Y7.
Impurity D NMT 0.5%.
Impurity B NMT 0.3%.
Impurity G NMT 0.15%.
5 Related substances by HPLC
Impurity H NMT 0.15%.
Unspecified impurities NMT 0.10%.
Total Impurity NMT 1.0%.
6 Loss on Drying NMT 0.5%.
7 Sulphated Ash NMT0.1%.
8 Assay (ODB) NLT 99.00 & NMT 101.00%.
Residual Solvents
a) Chloroform a) NMT 60 ppm.
9 b) Methanol b) NMT 3000 ppm.
c) Toluene c) NMT 890 ppm.
d) Ethylene dichloride d) NMT 5 ppm.
10 Bacterial endotoxin tests NMT 71.4 Eu/mg.

Result: The product complies as per BP standards.