TEST

SPECIFICATION

Appearance

White crystal powder

Indentification

First identification A, D

Second identification B, C, D.

A. Examine by infrared absorpption spectrophotometry(2. 2. 24), comparing with the spectrum obtained with phenoxymethylpenicillin potassium CRS

B. Examine by thin-layer chromatography(2. 2. 27), using silanised silica gel HR as the coating substance to be examined in 5ml of waterR.

C. Place about 2mg in a test-tube about 150mm long and 15mm in diameter. Mositen with 0. 05 ml of water R and add 2ml of sulphuric acid-formaldehyde reagent R. Mix te contents of the tube by swirling, the solution is reddish- brown. Place the test-tube in a water-bath for 1 min; a dark reddish-brown color develops.

D. It gives reaction (a) of potassium (2. 3. 1)

Solubility

Freely soluble in water, practically insoluble in chloroform, aether, clefin.

PH

Dissolve 50mg in carbon dioxide-free water Rand dilute to 10 ml with the same solvent. The ph of the solution is 5. 5 to 7. 5.

N, N-Dimethy lanlline

Not more than

Specific optical rotation

Dissolve 0. 25. G in carbn dioxide- free water R and dilute to 25. 0ml with the same solvent. The specific optical rotation is +215℃ to + 230℃, calculated with reference to the anhydrous substance.

Assat (on dry basis)

95. 5%~100. 5%