99% Sterile lyophilized powder / Acyclovir Sodium

description

white to pale yellow,crystalline powder odourless or almost odourless

solubility

soluble in chloroform;sparingly soluble in ethanol(95%)and in ether,practically insoluble in water.

identification

(a)i.r

(a)the ir spectrum of the sample is concordant with the reference spectrum of acyclovir in ws.

(b)u.v.

(b)the light absorption in the ragne of 230 to 360nm exhibits at about 320nm,about 0.45

(c)colour test

(c)a violet pink colour develops

(d)melting point

(d)between 158°c and 162°c

heavy metals

not more than 20ppm

related substance

tlc

maximum 0.5.percent

hplc

guanine:maximum 0.7percent

single impurity:maximum 0.5percent

total impurities:maximum 1.0.percent

sulphated ash

not more than 0.1%

loss on drying

not more than 5.0%

assay

not less than 98.0% and more than 101.0% of acyclovir calculated with reference to the dried substance.

residual solvents acetone

not more than 500ppm

organic volatile impurities

meets the requirements

part b(informative parameters)

bulk density

unlapped

0.20 to 0.40gm/ml

tapped

0.30 to 0.70gm/ml

sieve analysis

not less than 100% passes through 600 mesh

foreign particles

should be free from visible foreign particles