SPECIFICATION OF METAXALONE [I. H. S]
SR. NO. TEST OBSERVATION SPECIFICATION
1. Description White to almost white crystalline powder. White to almost white crystalline powder.
2. Solubility Complies Freely soluble in dichloromethane, soluble in methanol and chloroform, sparingly soluble in ethly acetate, practically insoluble in water.
3. Identificationa) IRb) Melting point Complies I. R. Absorption spectrum in KBr dispersion is concordant with similarly recorded spectrum of reference standard.1180 1250C
4 Clarity Complies A 1 % w/v solution in methanol is clear and free from any extraneous matter.
5. Loss on drying at 800 C under vacuum for 3 hours 0.47 Not more than 0.5 %
6. Colour Index Complies Absorbance of 1 cm layer of 1 % w/v solution in methanol at 420 nm is less than 0.05 Au.
7 Sulphated ash 0.18 Not more than 0.2 %
8 Heavy metals 16ppm Not more than 20ppm
9 Chlorides 193ppm Not more than 200ppm
10 Sulphates 289ppm Not more than 300ppm
11 Related substances( by HPLC ) a) Methyl urethaneb) MTX IIc) Any other impurity inviduallyd) Total impurity a)0.18%b)0.19%c)0.16%d)0.92% a) Not more than 0.2 %b) Not more than 0.2%c) Not more than 0.2%d) Not more than 1.0%
12 Assay ( by HPLC ) ( on dried basis ) 98.93% 98.0 102.0 %