|
Pure
Dry
· BHT is Butylated Hydroxy Toluene & BHA is Butylated
Hydroxy Anisole
· Total stabilizer concentration - 4.5mg/mIU
|
| No |
Test |
Specification
|
| 1 |
Appearance |
Yellow colored crystals |
| 2 |
Solubility |
Practically insoluble
in water, soluble in alcohol, methanol, chloroform, ether. |
| 3 |
Identification
a. UV (EP)
b. Colour Development
(USP 24)
c. TLC (USP 24)
|
A solution in isopropanol exhibits an absorption maximum between
325 nm and 327 nm.
A solution in chloroform produces a transient bright blue colour
with antimony trichloride solution.
Rf value of Blue green spot obtained with sample matches with
Rf value for similar spot obtained with reference. |
| 4 |
Absorbance ratio
(USP 24) |
Ratio of corrected
absorbance (at 325 nm) to observed absorbance is not less than
0.85. |
|
5
|
Acid value (EP) |
Not more than 2.0,
determined on 2 g as per procedure given in EP. |
| 6 |
Peroxides (EP) |
Color obtained using
sol. A is not more intense than that obtained with sol. B (as
per the procedure given for peroxide determination in EP). |
| 7 |
Chromatographic Purity
by HPLC
(In house)
|
Any individual isomeric
impurity - NMT 0.5%
Cis isomer - NMT 4.0%
Total impurities - NMT 5.0% |
| 8 |
Assay
(USP 24<571>)
|
Not less than 3.116
x 106 IU /g
(Not less than 95% of the label claim) |
