|
Product Name |
Mefenamic Acid BP/EP |
|
|
IUPAC Name |
N-(2,3-xylyl) anthranilic acid |
|
|
Molecular Formula |
C15H15NO2 |
|
|
Molecular Weight |
241.3 |
|
|
CAS No. |
61-68-7 |
|
|
Use |
Anti Inflammatory Analgesic |
| Sr. No. | TEST | SPECIFICATIONS |
| 1. | Description | A white or almost white, microcrystalline powder. |
| 2. | Solubility | Practically insoluble in water, slightly soluble in ethanol(96%) and in methylene chloride. It dissolve in dilute solutions of alkali hydroxides. |
| 3. | Identification | |
| The infra-red absorption spectrophotometry | Compare the IR spectrum with that obtained with mefenamic acid RS or with the reference spectrum of mefenamic acid. | |
| 4. | Related Substances by HPLC | Individual Known Impurity Impurity C : Not More Than 0.1% Impurity D : Not More Than 0.1%Impurity A : Not More Than 100 ppm Any Individual Unspecified Impurity : NMT 0.1% Total Impurity : Not More Than 0.2% |
| 5. | Copper | Less than 10 ppm |
| 6. | Loss on drying | Not more than 0.5 % |
| 7. | Sulphated Ash | Not more than 0.1 % |
| 8. | Assay on dried basis, w/w | Not less than 99.0 % and Not more than 101.0 % |
