Recommended for the enrichment of Clostridia from pharmaceutical products in accordance with the microbial limit testing by harmonized methodology of USP/EP/BP/JP/IP.
Ingredients:
Peptone: 10 g/L
HM Peptone B# (Equivalent to Beef Extract): 10 g/L
Yeast Extract: 3 g/L
Glucose monohydrate: 5 g/L
Sodium chloride: 5 g/L
Soluble starch: 1 g/L
Cysteine hydrochloride: 0.5 g/L
Sodium acetate: 3 g/L
Agar: 0.5 g/L
Directions:
Suspend 37.54 grams (the equivalent weight of dehydrated medium per litre) in 1000 ml purified/distilled water. Heat to boiling to dissolve the medium completely. Dispense into tubes or flasks as desired. Sterilize by autoclaving at 15 lbs pressure (121°C) for 15 minutes or as per validated cycle.
Quality Control:
Appearance: Cream to yellow homogeneous free flowing powder
Colour and Clarity of prepared medium: Light yellow coloured clear solution in tubes.
pH: 6.6 - 7.0
Growth Promotion Test: Growth promotion was carried out in accordance with the harmonized method of USP/EP/BP/JP/IP, and growth was observed under anaerobic conditions after an incubation at 30-35°C for <=48 hours
Growth promoting properties: Clearly visible growth of microorganism comparable to that previously obtained with previously tested and approved lot
of medium occurs at the specified temperature for not more than the shortest period of time specified inoculating not more than 100 cfu under anaerobic conditions (at 30-35°C for <=48 hours).
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