|
Tests |
In House Specifications |
|
Description |
White powder |
|
Solubility |
Freely soluble in water, slightly soluble in alcohol, practically insoluble in ether. |
IDENTIFICATION IR
Melting range
Angle of optical rotation
|
Infrared absorption spectrophotometry to compare with the spectrum obtained with Reference Standard
178.0° to 182.0°C
-0.10 to + 0.10°
|
Clarity of solution
a) 1%w/v Solution in water
b) 15w/v solution in Methanol
|
Clear
Clear |
|
pH of 1%w/v aqueous solution |
6.0-8.0 |
|
Heavy metals |
NMT 0.5% w/w |
|
Loss on drying |
NMT 0.5% w/w |
|
Residue on ignition ( Sulphated ash) |
NMT 0.20%w/w |
|
Assay (Titrimetry).On dry basis. |
Between 98.5% and 101.5% w/w |
|
Lysine content (titrimetry) |
40.0-43.0% w/w |
|
Ibuprofen content( by HPLC) |
57.0-60.0% w/w |
Related Substance by HPLC)
a) 2-(4-Isobutyryl phenyl) Propionic acid
b) Unidentified impurity
c) Total impurity
|
NMT 0.10%
NMT 0.10%
NMT 0.50%
|
