Plot No. C40, Road No. 21Y, MIDC, Wagle Industrial Estate,
Thane(W)-400604, MH, India.
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Intended use
Recommended for the preparation of test suspension in accordance with harmonized methods of USP, EP, BP, JP & IP.
Composition**
| Ingredients | g/L |
|---|---|
| Potassium dihydrogen phosphate | 3.600 |
| Disodium hydrogen phosphate dihydrate | 7.200 |
| Sodium chloride | 4.300 |
| HMC peptone # | 1.000 |
| Final pH (at 25°C) | 7.00 |
**Formula adjusted, standardized to suit performance parameters
# Equivalent to Peptone (meat or casein)
Directions
Label the ready to use LQ123DS bottle. Inoculate the 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.
Preparation of test strain is recommended in Buffered Sodium chloride- Peptone solution pH 7.0 at 30-35°C wherein there is no multiplication of organisms or there is no decrease in count for upto 4 hours. The medium also supports the repair of injured cells that have sensitivity to low pH.
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 in bottle.
Colour
Colourless solution.
Quantity of medium
500ml of medium in bottle
pH
7.00-7.00
Sterility Check
Passes release criteria
Growth Promotion Test
In accordance with the harmonized method of 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 20-25°C for <= 5 days for fungi
| Organism | Inoculum (CFU) | Recovery within 2 hours of incubation (stored at 2-8°C) | Recovery within 4 hours of incubation (stored at 2-8°C) | Recovery within 24 hours of incubation (stored at 2-8°C) |
|---|---|---|---|---|
| Escherichia coli ATCC 8739 (00012*) | 50-100 | no decrease in colony count | no decrease in colony count | no decrease in colony count |
| Escherichia coli ATCC 25922 (00013*) | 50-100 | no decrease in colony count | no decrease in colony count | no decrease in colony count |
| Staphylococcus aureus subsp. aureus ATCC 6538 (00032*) | 50-100 | no decrease in colony count | no decrease in colony count | no decrease in colony count |
| Staphylococcus aureus subsp. aureus ATCC 25923 (00034*) | 50-100 | no decrease in colony count | no decrease in colony count | no decrease in colony count |
| ^Pseudomonas paraeruginosa ATCC 9027 (00026*) | 50-100 | no decrease in colony count | no decrease in colony count | no decrease in colony count |
| Pseudomonas aeruginosa ATCC 27853 (00025*) | 50-100 | no decrease in colony count | no decrease in colony count | no decrease in colony count |
| Salmonella Typhimurium ATCC 14028 (00031*) | 50-100 | no decrease in colony count | no decrease in colony count | no decrease in colony count |
| Salmonella Abony NCTC 6017 (00029*) | 50-100 | no decrease in colony count | no decrease in colony count | no decrease in colony count |
| **Bacillus spizizennii ATCC 6633 (00003*) | 50-100 | no decrease in colony count | no decrease in colony count | no decrease in colony count |
| $ Kocuria rhizophila ATCC 9341 | 50-100 | no decrease in colony count | no decrease in colony count | no decrease in colony count |
| Candida albicans ATCC 10231 (00054*) | 50-100 | no decrease in colony count | no decrease in colony count | no decrease in colony count |
| Candida albicans ATCC 2091 (00055*) | 50-100 | no decrease in colony count | no decrease in colony count | no decrease in colony count |
Key: (*) Corresponding WDCM numbers,
^ Formerly known as Pseudomonas aeruginosa
** Formerly known as Bacillus subtilis subsp. spizizenii
$ 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 and material that comes into contact with sample must be decontaminated and disposed of in accordance with current laboratory techniques (6,7).
| Product Name | Buffered Sodium Chloride Peptone Solution pH 7.00 |
|---|---|
| SKU | LQ123DS |
| Customized Product Available | No |
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