Buffered Sodium Chloride Peptone Solution pH 7.00 w/1% Soya Lecithin

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SKU:
LQ196C


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
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 LQ196C 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. Lecithin neutralizes quaternary ammonium compounds and polysorbate 80 neutralizes phenolic disinfectants, hexachlorophene, formalin and with lecithin ethanol (6).

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

  1. 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/1% Soya lecithin in a glass bottle.

Colour
Off white to 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

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 (7,8).

More Information
Product Name Buffered Sodium Chloride Peptone Solution pH 7.00 w/1% Soya Lecithin
SKU LQ196C
Customized Product Available No
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