|
Specifications
| TEST |
UNIT |
SPECIFICATIONS |
TEST METHOD |
| Description |
|
A white or almost white, crystalline powder or
colourless crystals; odour, slight. |
TM/IBU-IP/001 |
Identification
1st Identification A,
2nd Identification B,C |
|
| By IR The infra-red absorbance spectrum
obtained from the sample should be concordant with spectrum
obtained with that Ibuprofen RS or with reference spectrum of
Ibuprofen. |
| By UV Exhibits 2 absorption maxima, at about 264 nm and
about 272 nm. The ratio of the absorbance measured at the
maximum at about 264 nm to that measured at the shoulder at
about 258 nm is 1.20 to 1.30. The ratio of the absorbance
measured at the maximum at about 272 nm to that measured at the
shoulder at about 258 nm is 1.00 to 1.10. |
| 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-IP/002 |
| Appearance of solution. |
|
10% w/v solution in ethanol (95%) should be clear
and colorless. |
TM/IBU-IP/003 |
| Optical rotation |
|
0.050 to - 0.0500 |
TM/IBU-IP/004 |
| Sulphated ash(w/w) |
% Max. |
0.10 |
TM/IBU-IP/005 |
| Heavy Metals |
Max, ppm |
10 |
TM/IBU-IP/006 |
| Loss on drying |
% Max. |
0.50 |
TM/IBU-IP/007 |
| Related Substances(By HPLC) Individual
Impurity
|
| The sum of all Individual Impurity |
|
|
|
TM/IBU-IP/008 |
| Assay(with reference to the
dried substance) |
% Min to Max. |
98.50 to 101.0 |
TM/IBU-IP/009 |
*Storage Condition: Keep in Tight
Containers
**Standard packing size : Iburofen is packed in a standard pack
size of 40Kg and 50Kg. Packing weight can vary as per customer’s
requirements.
|
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