HiMedia Laboratories GmbH, Marie-Curie-Str. 3, 64683, Einhausen, Germany.
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Ready Media in Bottles or Tubes or Slants#4fa25a
Intended use
For the preparation of test suspension.
Composition**
| Ingredients | g/L |
|---|---|
| HMC Peptone# | 1.000 |
| Potassium dihydrogen phosphate | 3.600 |
| Disodium hydrogen phosphate dihydrate | 7.200 |
| Sodium chloride | 4.300 |
| Polysorbate 80 | 56.000 |
| Soya lecithin | 5.000 |
| Final pH (at 25°C) | 7.00 ±0.5 |
#Equivalent to Peptone (meat or casein)
**Formula adjusted, standardized to suit performance parameters
Directions -
Label the ready to use LQ360C bottle. Inoculate the sample and Incubate at specified temperature and time.
Principle And Interpretation
The composition of Buffered Sodium Chloride Peptone Solution is in accordance with the harmonized methodology of USP/EP/BP/JP/IP(1-5). This medium is recommended for preparation of stable test strain suspension employed for validating the microbiological testing procedures of non-sterile products. The standardized stable suspensions are used so that the suitability of this test to detect microorganism in presence of product can be established. Non-fatty products insoluble in water and water-soluble products are diluted/dissolved using this solution. HMC Peptone serves as nutrient source and maintains the cell viability. Phosphates in the medium act as good buffering agents. Sodium chloride maintains the osmotic balance.. Polysorbates reduce surface tension and also inactivate phenolic compound, if present in the test sample. Lecithin and polysorbate 80 (Tween 80) are neutralizers reported to inactivate residual disinfectants from where the sample is collected (6). Lecithin neutralizes quaternary ammonium compounds and polysorbate 80 neutralizes phenolic disinfectants, hexachlorophene, formalin and with lecithin ethanol (7).
Type of specimen
Pharmaceutical samples
Specimen Collection and Handling
For pharmaceutical samples follow appropriate techniques for handling specimens as per established guidelines (1-5). After use, contaminated materials must be sterilized by autoclaving before discarding.
Warning and Precautions
Read the label before opening the container. Wear protective gloves/protective clothing/eye protection/face protection. Follow good microbiological lab practices while handling specimens and culture. Standard precautions as per established guidelines should be followed while handling specimens. Safety guidelines may be referred in individual safety data sheets.
Limitations
- This medium contains less nutrients and is not recommended for the growth of microorganisms.
Performance and Evaluation
Performance of the medium is expected when used as per the direction on the label within the expiry period when stored at recommended temperature.
Quality Control
Appearance: Sterile clear Buffered Sodium Chloride Peptone Solution w/ 0.5% Soya lecithin and 5.6% Polysorbate 80 in a glass bottle.
Colour: Light yellow coloured opalescent solution
Quantity of medium: 100ml of medium in bottle
pH: 6.50-7.50
Growth Promotion Test: Growth Promotion is carried out in accordance with the harmonized method of ICH(USP/EP/BP/JP/IP).
Sterility Check: Passes release criteria
Cultural characteristics observed after recovery on Soybean Casein Digest Agar after an incubation at 30-35°C for 18-24 hours for bacteria and Sabouraud Dextrose Agar at 30-35°C for 24-48 hours.
| Organism | Inoculum (CFU) | Recovery within 2 hours of incubation | Recovery within 4 hours of incubation | Recovery within 24 hours of incubation |
|---|---|---|---|---|
| Preparation of test strain | ||||
| Escherichia coli ATCC 8739 (00012*) | 50-100 | no decrease in colony count | no decrease in colony count | no decrease in colony count (stored at 2-8°C) |
| Escherichia coli ATCC 25922 (00013*) | 50-100 | no decrease in colony count | no decrease in colony count | no decrease in colony count (stored at 2-8°C) |
| Staphylococcus aureus subsp. aureus ATCC 6538 (00032*) | 50-100 | no decrease in colony count | no decrease in colony count | no decrease in colony count (stored at 2-8°C) |
| Staphylococcus aureus subsp. aureus ATCC 25923 (00034*) | 50-100 | no decrease in colony count | no decrease in colony count | no decrease in colony count (stored at 2-8°C) |
| ^Pseudomonas paraeruginosa ATCC 9027 (00026*) | 50-100 | no decrease in colony count | no decrease in colony count | no decrease in colony count (stored at 2-8°C) |
| Pseudomonas aeruginosa ATCC 27853 (00025*) | 50-100 | no decrease in colony count | no decrease in colony count | no decrease in colony count (stored at 2-8°C) |
| Salmonella Typhimurium ATCC 14028 (00031*) | 50-100 | no decrease in colony count | no decrease in colony count | no decrease in colony count (stored at 2-8°C) |
| Salmonella Abony NCTC 6017 (00029*) | 50-100 | no decrease in colony count | no decrease in colony count | no decrease in colony count (stored at 2-8°C) |
| **Bacillus spizizennii ATCC 6633 (00003*) | 50-100 | no decrease in colony count | no decrease in colony count | no decrease in colony count (stored at 2-8°C) |
Key : (*) Corresponding WDCM numbers,
^ Formerly known as Pseudomonas aeruginosa
** Formerly known as Bacillus subtilis subsp. spizizenii
| Product Name | Buffered Sodium Chloride Peptone Solution w/ 0.5% Soya lecithin & 5.6% Polysorbate 80 |
|---|---|
| SKU | LQ360C |
| Customized Product Available | No |
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