HiMedia Laboratories GmbH, Marie-Curie-Str. 3, 64683, Einhausen, Germany.
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Lactose Monohydrate Sulphite Medium (Medium R)
Recommended for detection and enumeration of Clostridium perfringens in pharamaceutical products.
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Intended Use
Lactose Monohydrate Sulphite Medium is recommended for detection and enumeration of Clostridium perfringens in pharmaceutical products in accordance with European Pharmacopoeia 2008.
Composition**
| Ingredients | Gms / Litre |
|---|---|
| Pancreatic digest of casein | 5.000 |
| Yeast extract | 2.500 |
| Sodium chloride | 2.500 |
| Lactose monohydrate | 10.000 |
| Cysteine hydrochloride | 0.300 |
| Final pH (at 25°C) | 7.1±0.1 |
**Formula adjusted, standardized to suit performance parameters
Directions
Suspend 19.8 grams of dehydrated medium in 1000 ml purified/ distilled water. Heat if necessary to dissolve the medium completely. Dispense in tubes containing inverted Durham's tubes. Sterilize by autoclaving at 15 lbs pressure (121°C) for 15 minutes.Cool to 45-50°C and add filtersterilized solution of 1.2% sodium metabisulphite R (0.5ml) and 1.0% ferric ammonium citrate (0.5ml) to each tube.
Principle And Interpretation
Lactose monohydrate sulphite Broth Base is prepared as per the European Pharmacopoeia (1) formula and is cited as Medium R. This medium is useful in semi-quantitative test for presence of Clostridium perfringens in pharmaceutical products where the level of this species is a criterion of quality.
The medium contains pancreatic digest of casein and yeast extract which provides essential nitrogenous compounds for Clostridia Lactose serves as carbon or fermentable carbohydrate source. Cystine hydrochloride rich in sulphur content provides reduced conditions. Sodium metabisulphite and ferric ammonium citrate act as indicators of sulphite reduction, indicated by blackening of the medium.
Quality Control
Appearance
Cream to yellow homogeneous free flowing powder
Colour and Clarity of prepared medium
Light amber coloured clear solution without any precipitate
pH
7.00-7.20
Growth Promotion Test
As per European Pharmacopoeia.
Cultural Response
ME1287: Cultural characteristics after an incubation at 46±0.5°C for 24-48 hours.
| Organism | Inoculum (CFU) | Growth | H2S | Gas |
|---|---|---|---|---|
| Clostridium perfringens ATCC 12924 | 50-100 | luxuriant | Positive reaction, blackening of medium | Positive reaction |
| Clostridium perfringens ATCC 13124 | 50-100 | luxuriant | Positive reaction, | Positive reaction |
Storage and Shelf Life
Store below 30°C in tightly closed container and the prepared medium at 2-8°C. Use before expiry date on the label.
| Product Name | Lactose Monohydrate Sulphite Medium (Medium R) |
|---|---|
| SKU | ME1287 |
| Customized Product Available | No |
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