|
Product Name |
Mefenamic Acid IP |
|
|
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 to greyish-white, microcrystalline powder |
| 2. | Solubility | Sparingly soluble in ether, slight soluble in ethanol (95 percent) and in chloroform, practically insoluble in water |
| 3. | Identification | (A) By IR : Infrared spectrum should compare with that obtained with mefenamic acid RS (B) The test solution does not exhibits florescence at 365nm (C) Intense blue colour is produced immediately which fades rapidly to brownish-green |
| 4. | Light absorption | Maximum at 279nm 0.69 to 0.74 Maximum at 350nm 0.56 to 0.60 |
| 5. | Copper | NMT 20 ppm |
| 6. | 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% |
| 7. | Sulphated Ash | NMT 0.1%w/w |
| 8. | Loss on drying | NMT 1.0%w/w |
| 9. | Assay (On dried basis) | NLT 99.0% and NMT 100.5%w/w |
