| TEST |
UNIT |
SPECIFICATIONS |
TEST METHOD |
| Description |
|
White or almost white, crystalline powder or
colourless crystals. |
TM/IBU-BP/001 |
| Solubility |
|
Practically insoluble in water, freely
soluble in Acetone, in methanol and in methylene chloride. It
dissolves in dilute solutions of alkali hydroxides and carbonates. |
TM/IBU-BP/002 |
Identification
1st Identification A,C
2nd Identification A,B,D |
0C |
| Melting Point 75.0-78.0 |
| By UV Exhibits 2 absorption maxima, at 264 nm and 272 nm.
The ratio of the absorbance measured at the maximum at 264 nm to
that measured at the shoulder at 258 nm is 1.20 to 1.30. The
ratio of the absorbance measured at the maximum at 272 nm to
that measured at the shoulder at 258 nm is 1.00 to 1.10. |
| By IR The infra-red absorbance spectrum obtained from the
sample should be concordant with spectrum obtained from the
standard. |
| By TLC The principal spot in the chromatogram obtained with
the test solution is similar in position, color and size to the
principal spot in the chromatogram obtained with the reference
solution. |
|
TM/IBU-BP/003 |
| Appearance of solution |
|
10% w/v solution in methanol R should be clear and
colorless. |
TM/IBU-BP/004 |
| Optical rotation |
|
- 0.050 to 0.050 |
TM/IBU-BP/005 |
Related Substances
| Impurity –A |
| Impurity –J |
| Impurity –N |
| Total Impurity |
| Unspecified Impurity |
|
| % Max. |
| % Max. |
| % Max. |
| % Max. |
| % Max. |
|
|
TM/IBU-BP/006 |
| Impurity -F |
% Max. |
0.1 |
TM/IBU-BP/007 |
| Heavy Metals |
Max, ppm |
10 |
TM/IBU-BP/008 |
| Loss on drying |
% Max. |
0.5 |
TM/IBU-BP/009 |
| Sulphated ash(w/w) |
% Max. |
0.1 |
TM/IBU-BP/010 |
| Assay (with reference to the
dried substance) |
% Min to Max. |
98.5 to 101.0 |
TM/IBU-BP/011 |
Residual Solvents (GC)
| Trichloroethylene |
| Acetone |
| Isopropyl Alcohol |
| Hexane |
| Benzene |
|
|
| 80 Max. |
| 100 Max. |
| 100 Max. |
| 100 Max. |
| 2 Max |
|
TM/IBU-A/001 |
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