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Etodolac (Micronized)

Etodolac (Micronized)

1,8-Diethyl-1,2,3,4,9-tetrahydropyrano[3,4-b]indole-1-acetic acid USP/EP

C16H11Cl K2N204
Mol. Wt.: 287.35
CAS 41340-25-4
White to off-white crystalline powder

Medical Use/Therapeutic Category
- Soluble in methanol, ethanol 96 %, aqueous polyethylene glycol
- Insoluble in water
A. Infrared spectrum:  Conforms to that of the USP-RS and EPCRS  
B. Melting point (EP):  144 – 150˚ C (rate 2˚ C/min.)

Chromatographic Purity (related substances)
Any unidentified impurity:  Not more than 0.1 %
Total impurities:  Not more than 1.0 %

Assay (by Titration and HPLC)
98.0 – 102.0 % (on dried basis)

Other Tests
Chlorides:  Not more than 300 ppm
Heavy metals:  Not more than 10 ppm
Melting range (USP):  146˚-151˚C (rate 2˚ C/min.)
Optical rotation (EP):  -0.10 to +0.10˚
Particle size: 90 % less than 10 microns
Residue on ignition (sulfated ash):  Not more than 0.1%
Water content:  Not more than 0.5%

Specifications and Analytical Methods – available upon request

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