Plot No. C40, Road No. 21Y, MIDC, Wagle Industrial Estate,
Thane(W)-400604, MH, India.
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Intended Use
Used as diluent.
Composition
| Ingredients | g/L |
|---|---|
| Sodium chloride | 9.000 |
| Polysorbate 80 (Tween 80) | 0.500 |
**Formula adjusted, standardized to suit performance parameters
Directions
Label the ready to use LQ200X bottle. Inoculate the bottle with the pre-determined volume of the sample or 50-100 CFU of a known culture (as positive control) and incubate at 35-37°C for 24-48 hours.
Principle And Interpretation
Saline solution maintains the osmotic balance in microbial cells and helps to maintain the cell integrity and viability. Normal saline is used for preparing microbial suspensions for detection of antimicrobial agents, or to growth media used for disk susceptibility testing. It is also used in the preparing of stock solutions and serial dilutions of antimicrobial agents. Polysorbate 80 used as neutralizers.
Type of specimen
Pharmaceutical samples
Specimen Collection and Handling
For pharmaceutical samples follow appropriate techniques for handling specimens as per established guidelines (1,2).
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
- Saline solution does not support the growth of microorganism hence, further biochemical and serological tests must be carried out for further identification.
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 Saline 0.9% with 0.05% Tween 80 Solution in glass bottles.
Colour: Colourless solution.
Quantity of medium: 10ml of medium in bottle
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 hour 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 |
|---|---|---|---|
| Escherichia coli ATCC 8739 (00012*) | 50-100 | 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 |
| Staphylococcus aureus subsp. aureus ATCC 6538 (00032*) | 50-100 | 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 |
| Pseudomonas aeruginosa ATCC 27853 (00025*) | 50-100 | no decrease in colony count | nodecrease in colony count |
| Salmonella Typhimurium ATCC 14028 (00031*) | 50-100 | 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 |
| ** Bacillus spizizenii ATCC 6633 (00003*) | 50-100 | no decrease in colony count | no decrease in colony count |
| $ Kokuria rhizophila ATCC 9341 | 50-100 | 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 |
| Candida albicans ATCC 2091 | 50-100 | no decrease in colony count | no decrease in colony count |
Key: (*)- Corresponding WDCM Numbers
$ Formerly known as Micrococcus luteus
^ Formerly known as Pseudomonas aeruginosa
**Formerly known as Bacillus subtilis subsp. spizizenii
Storage and Shelf Life
On receipt 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 (1,2).
| Product Name | Sterile Saline,0.9% w/0.05% Tween 80 |
|---|---|
| SKU | LQ200X |
| Customized Product Available | No |
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