COMMERCIAL PRODUCT NAME 

:

TRAMADOL HYDROCHLORIDE

PRODUCT NO.

:

SAL009 

C.A.S. NUMBER

:

[22204-88-2]

STRUCTURE

:

MOLECULAR FORMULA

:

C 16 H 25 NO 2 .HCl 

MOLECULAR WEIGHT

:

299.85

CHEMICAL NAME

:

(±)-Trans-2-[(Dimethylamino) methyl]-1-(m- methoxyphenyl) cyclohexanol hydrochloride. 

SPECIFICATIONS 

:

Appearance 

:

White to almost white crystalline powder, taste bitter.

Solubility

:

Freely soluble in water and in methanol. Slightly soluble in chloroform & acetone. Soluble in HCl & acetic acid.

Identification

:

a. I.R. absorption

:

Comparable with working std.

b. Reaction for chloride

:

It should give chloride ppt.

Melting Range °C

:

178 – 18 2

Colour & clarity of solution

:

It should be clear & colourless. (10% W/V in water) U.V. light absorbance at 400 nm should be less than 0.12.

Acidity (1% W/V soln.in water)

:

pH : 5.0 – 6. 2

Heavy metals 

:

N.M.T. 0.002 %

Loss on drying % W/W

:

N.M.T. 0.5

Residue on ignition % W/W

:

N.M.T. 0.1

Total chromatographic 

:

Total impurities: N.M.T. 1.0 % 

Impurities (by H.P.L.C.)

:

Individual impurity: N.M.T. 0.5 %

Assay % W/W (On dry basis)

:

98.5 – 101. 5

APPLICATION

:

 An analgesic drug.

STORAGE

:

In air tight containers, protected from excessive heat.

STANDARD PACKAGING

:

In fibre containers 10 Kgs/ 25 Kgs/50 Kgs.