|
Specifications
| TEST |
UNIT |
SPECIFICATIONS |
TEST METHOD |
| Description |
|
White crystalline powder or colorless
crystals. |
TM/IBU-USP/001 |
| Identification |
|
By IR The infra-red absorbance spectrum obtained
from the sample should be concordant with spectrum obtained from the
standard.
By UV Respective absorptivities at 264 nm and 273 nm, calculate on
the anhydrous basis. Do not differ by more than 3.0%.
The chromatogram of the assay preparation obtained by as directed
in the assay exhibits a major peak for ibuprofen, the retention time
of which, relative to that of the internal standard, corresponds to
that exhibited in the chromatogram of the standard preparation,
obtained as directed in the assay. |
TM/IBU-USP/002 |
| Heavy Metals |
% Max. |
0.002 |
TM/IBU-USP/003 |
| Water
Content(w/w) |
% Max. |
1.0 |
TM/IBU-USP/004 |
| Residue on
Ignition(w/w) |
% Max. |
0.5 |
TM/IBU-USP/005 |
Chromatographic
Purity
| Individual Impurity (Area %)
|
| The sum of all the
Individual Impurity (Area %) |
|
|
|
TM/IBU-USP/006 |
| Limit of
ibuprofen related compound C |
% Max. |
0.1 |
TM/IBU-USP/007 |
| Assay (On
Anhydrous basis) |
% Min to Max. |
97.0 to 103.0 |
TM/IBU-USP/008 |
|
Residual Solvents (GC)
| Trichloroethylene |
| Acetone |
| Isopropyl Alcohol |
| Hexane |
| Benzene |
|
|
| 80 Max. |
| 100 Max. |
| 100 Max. |
| 100 Max. |
| 2 Max |
|
TM/IBU-A/001 |
* Benzene is not used in Manufacturing
Process
**Storage Condition: Keep in Tight Containers
***Standard packing size : The material is packed in a standard
pack size of 40Kg and 50Kg. However, packing size can vary depending
upon the customer’s requirements.
|
 |
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