A diluent recommended by the Harmonised European Ph
armacopoeia for the microbiological
examination of non-sterile pharmaceutical products.
The medium is also used to prepare and dilute
test suspensions of the microbiological strains des
cribed in the Harmonised European
Pharmacopoeia. Conforms to USP/EP/JP performance sp
ecification. The low level of peptone lessens
the physiological shock experienced by microorganis
m when suspended in a diluent. The dual
phosphate components create a buffered environment
and sodium chloride maintains the osmotic
Potassium dihydrogen phosphate
Disodium hydrogen phosphate dihydrate
Peptone (meat or casein)
Powder: fine, free-flowing, homogeneous, white/buff
Finished medium: Colourless, clear to slight haze
7.0 ± 0.2
Refer to appropriate SDS
Method for reconstitution
Disperse 16.1 grams of powder in 1 litre of deionis
ed water. Allow to soak for 10 minutes then swirl
to mix. Distribute into suitable vessels and steril
ise at 121°C for 15 minutes.
Test suspensions are made by inoculating the diluen
t with cultivated microorganisms. These
suspensions must be used within 2 hours if held at
room temperature or 24 hours if stored at 2-8°C.
No marked increase or decrease in original colony f
orming unit count should be observed. Refer to
the appropriate test protocol for further guidance.
Dehydrated culture media: 10-25
C away from direct sunlight.
Up to 7 days at 2-8°C in the dark
Minimum Q.C. organisms
Refer to specific guidelines as defined in the Harm
onised European Pharmacopoeia.
European Pharmacopoeia 9