Product Name:Diclofenac sodium ( BP2005 )Cas No.:15307-79-6Molecular Formula:C14H10Cl2NNa02Molecular Weight:318.13Appearance: White or yellowish crystalline powder
Appearance of solution: 40nm ≤0.05
Assay: 99.0%~101.0%
Related substances:
Single impurity: 0.2%max
Total impurities :0.5%max
Heavy metals: 10ppm Max
Loss on drying: 0.5%max
Package: 25kg/fibre drum
Diclofenac Sodium is the salt form of diclofenac, an active metabolite of the NSAID aceclofenac (sc-217557). Hydrolysis of aceclofenac, an inhibitor of interleukin-1B-induced prostaglandin E2 production with no inhibitory activity against Cox (cyclooxygenase), generates diclofenac, an inhibitor of both Cox-1 and Cox-2. Oxidation of diclofenac produces the metabolite 4'-hydroxy diclofenac (sc-202423) which demonstrates specific inhibition of Cox-2. Inhibition of Cox by diclofenac and 4'-hydroxy diclofenac suppresses prostaglandin E2 synthesis, producing antiinflammatory and analgesic effects. Diclofenac is also shown to stabilize the native tetrameric conformation of transthyretin (TTR) fibrils, preventing the formation of insoluble
amyloidogenic TTR deposits. Diclofenac Sodium is a substrate of CYP2C9.
Product Packaging
1) 1kg/bag (1kg net weight, 1.1kg gross weight, packed in an aluminum foil bag),or as required.
2) 25kg/drum (25kg net weight, 28kg gross weight; Packed in a cardboard-drum with two plastic-bags inside; Drum Size: 510mm high, 360mm diameter)
Storage
Stored in a cool and dry well-closed container. Keep away from moisture and strong light/heat.
Delivery
Usually within 3-7 working days after payment
ITEMS | SPECIFICATION EP6/USP32 | RESULTS |
CHARACTERS(PH.EUR.) | A WHITE OR ALMOST WHITE,CRYSTALLINE POWDER | COMPLIES |
SOLUBILITY(PH.EUR.) | PRACTICALLY INSOLUBLE IN WATER,SPARINGLY SOLUBLE IN ACETONE AND IN ALCOHOL,SLIGHTLY IN METHYLENE CHLORIDE | COMPLIES |
IDENTIFICATION | ||
A.IR-SPECTRUM(PH.EUR) | MEETS THE REQUIREMENT | COMPLIES |
B.TLC(PH.EUR) | MEETS THE REQUIREMENT | COMPLIES |
A.IR-SPECTRUM(USP) | MEETS THE REQUIREMENT | COMPLIES |
B.UV ABSORPTION(USP) | MEETS THE REQUIREMENT | COMPLIES |
SPECIFIC OPTICAL ROTATION | ||
(PH.EUR) | BETWEEN+150°AND +156° | +152.1° |
(USP) | BETWEEN+150°AND +156° | +153.3° |
LOSS ON DRYING | ||
(PH.EUR) | NOT MORE THAN 1.0% | 0.04% |
(USP) | NOT MORE THAN 1.0% | 0.05% |
RESIDUE ON IGNITION(USP) | NEGLIGIBLE,FROM 100MG | COMPLIES |
RELATED SUBSTANCES(PH.EUR) | ||
ANY INDIVIDUAL IMPURITY | NOT MORE THAN 0.5% | 0.30% |
SUM OF IMPURITIES | NOT MORE THAN 1.5% | 1.24% |
CHROMATOGRAPHIC PURITY(USP) | ||
ANY INDIVIDUAL IMPURITY | NOT MORE THAN 0.5% | 0.28% |
SUM OF IMPURITIES | NOT MORE THAN 2.0% | 1.25% |
ASSAY | ||
UV ABSORPTION(PH.EUR.) | BETWEEN 97.0% AND 103.0% | 100.70% |
HPLC(USP) | BETWEEN 97.0% AND 102.0% | 98.70% |
RESIDUAL SOLVENT(IN-HOUSE) | ||
METHANOL | NOT MORE THAN 500PPM | NOT DETECT OUT |
ETHANOL | NOT MORE THAN 2000PPM | 455PPM |
METHYLENE CHLORIDE | NOT MORE THAN 600PPM | NOT DETECT OUT |
CONCLUSION:THE PRODUCT CONFORMS TO PH.EUR.6/USP34 | ||
Other product:
| benzocaine | 94-09-7 |
| Procaine | 59-46-1 |
| Procaine Hydrochloride | 51-05-8 |
| tetracaine | 94-24-6 |
| tetracaine hydrochloride | 136-47-0 |
Packing :
