HiMedia Laboratories GmbH, Marie-Curie-Str. 3, 64683, Einhausen, Germany.
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Buffered Sodium Chloride Peptone Solution pH 7.00 w/1% Polysorbate 80
The composition of this medium 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
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Intended use
Recommended for the preparation of test suspension.
Composition**
| Ingredients | g / L |
|---|---|
| Potassium dihydrogen phosphate | 3.600 |
| Disodium hydrogen phosphate dihydrate | 7.200 |
| Sodium chloride | 4.300 |
| HMC Peptone # | 1.000 |
| Polysorbate 80 (Tween 80) | 10.000 |
| Final pH (at 25°C) | 7.00±0.5 |
**Formula adjusted, standardized to suit performance parameters
# Peptone (meat or casein)
Directions
Label the ready to use LQ266X bottle. Inoculate 50-100 cfu sample and Incubate at specified temperature and time.
Principle And Interpretation
The composition of this medium 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 and cell integrity. Polysorbates reduce surface tension and also inactivate phenolic compound, if present in the test sample.
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 Buffered Sodium Chloride Peptone Solution with 1% Polysorbate 80 in glass bottle.
Colour
Colourless to pale yellow clear solution
Quantity of medium
10 ml of medium in bottle
pH
6.50-7.50
Sterility Check
Passes release criteria
Growth Promotion Test
Growth Promotion is carried out in accordance with the harmonized method of ICH(USP/EP/BP/JP).
Cultural response
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 |
|---|---|---|---|---|
| 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 spizizenii 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) |
| $ Kokuria rhizophila ATCC 9341 |
50-100 | no decrease in colony count |
no decrease in colony count |
no decrease in colony count (stored at 2-8°C) |
| Candida albicans ATCC 10231 (00054*) |
50-100 | no decrease in colony count |
no decrease in colony count |
no decrease in colony count (stored at 2-8°C) |
| Candida albicans ATCC 2091 (00055*) |
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 Bacillus subtilis subsp. spizizenii
^ Formerly known as Pseudomonas aeruginosa
$ Formerly known as Micrococcus luteus
Storage and Shelf Life
Store between 15-30°C. Use before expiry date on the label. Product performance is best if used within stated expiry period.
Disposal
User must ensure safe disposal by autoclaving and/or incineration of used or unusable preparations of this product. Follow established laboratory procedures in disposing of infectious materials must be decontaminated and disposed of in accordance with current laboratory techniques (6,7).
| Product Name | Buffered Sodium Chloride Peptone Solution pH 7.00 w/1% Polysorbate 80 |
|---|---|
| SKU | LQ266X |
| Customized Product Available | No |
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