Description
Description
| TESTS | SPECIFICATIONS | RESULTS |
| Appearance | White or almost white, crystalline powder | Almost white crystalline powder |
| Solubility | Freely soluble in water and in methanol; slightly soluble in alcohol, in dehydrated alcohol, and in tetrahydrofuran; practically insoluble in acetone, in dichloromethane, in toluene, in ethyl acetate,in dioxane,in hexane,in butyl alcohol,and acetonitrile | Conforms |
| Identification | UV:Maximum absorption at 243nm,318nm.Minimum absorption at 268nm | Conforms |
| TLC:color and position of principal spot obtained with test solution consistent with that of the reference solution | Conforms | |
| IR | Conforms | |
| pH | 5.7~6.7 | 6.1 |
| Melting range | 165~170°C | 166~168°C |
| Clarity and color of solution | The solution should be clear and colorless ,if not ,not more intensely turbid than No.1 reference solution and not more intensely colored than reference solution of Y1 | Conforms |
| Related substances | 1-ketone-ketorolac acid≤0.1% | 0.0027% |
| 1-hydroxyl-ketorolac acid≤0.1% | N.D | |
| Other single impurity≤0.5% | 0.12% | |
| Total impurities≤1.0% | 0.17% | |
| Dichloromethane | Peak area of dichloromethane in test solution is not more than that of reference solution | N.D |
| Loss on drying | ≤0.5% | 0.08% |
| Residue on ignition | ≤0.1% | 0.09% |
| Heavy metals | ≤0.002% | Conforms |
| Assay (on the dried basis) | 98.5~101.5% | 99.2% |
| Conclusion | The product meets the requirements of USP | |
Packaging details:
| Packaging details: | 25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
| Storage: | Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
| Shelf Life: | 5 years if sealed and store away from direct sun light. |
Additional Information
The most widely recognized markets for this item incorporate the accompanying nations. If you don’t mind ask with us if your nation or district isn’t recorded:
ASIA: Afghanistan, Israel, Jordan, Pakistan, Russia, Saudi Arabia, Singapore, Syria, Philippines, Turkey, Turkmenistan, Uzbekistan, Yemen, Vietnam, Indonesia, Malaysia, Iran, Tajikistan, and so forth.
AFRICA: South Africa, Uganda, Nigeria, Ghana, Kenya, Mauritius, Botswana, Egypt, Ethiopia, Libya, Sudan, Congo, Gambia, Ivory Coast , and so forth.
NORTH & SOUTH AMERICA: USA, Canada, Panama, Trinidad and Tobago, Costa Rica, Puerto Rico, Dominican Republic, Argentina, Guatemala, Guyana, Peru, Bolivia, Venezuela , Brazil, Bahamas, Ecuador, and so forth .
EUROPE: Austria , Azerbaijan, Belarus, Belgium, Cyprus, Czech Republic, Denmark, France, Georgia, Germany, Hungary, Ireland, Iceland, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, Ukraine, United Kingdom (UK) , Latvia, and so forth.
OCEANIA: Australia, New Zealand, Fiji, and so forth.
