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Diluting Fluid K

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SKU:
LQ122C

Intended Use

Used as diluent in testing of pharmaceuticals in accordance with USP.

Composition

Ingredients g/L
Peptone 5.000
HM peptone B # 3.000
Polysorbate 80 (Tween 80) 10.000
Final pH (at 25°C) 6.9±0.2

**Formula adjusted, standardized to suit performance parameters

# Equivalent to Beef extract

Directions

Label the ready to use LQ122C bottle w/ screw cap with septum.. Inoculate 50-100 cfu sample and Incubate at specified temperature and time.

Principle And Interpretation

Diluting Fluid K is recommended as rinsing fluid for membrane filter method used in validation tests for bacteriostasis and fungistasis activity of pharmaceutical articles before carrying out sterility test procedures as per USP (1). After filtering the specified quantity of the test specimen, the membrane is rinsed with measured portions of rinsing or diluting fluid. This rinse is inoculated with known number of test bacteria and fungi as specified in pharmacopoeia. The resultant growth is compared with positive control to determine presence of fungistasis or bacteriostasis activity in test specimen.

Type of specimen

Pharmaceutical sample

Specimen Collection and Handling

For pharmaceutical sample samples follow appropriate techniques for handling specimens as per established guidelines (1). 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

  • Freshly prepared medium plates must be used or it may result in erroneous results.
  • Use of this method is appropriate only when test samples are clear.

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 Diluting Fluid K in bottle.

Colour

Light yellow coloured medium

Quantity of medium

100 ml of medium in bottle

Sterility Check

Passes release criteria

pH

6.70-7.10

Cultural Response

Cultural characteristics observed after an incubation at 30-35°C for 24-48 hours

Organism Inoculum
(CFU)		 Growth
Escherichia coli
ATCC 8739 (00012*)		 50-100 good
Escherichia coli
ATCC 25922 (00013*)		 50-100 good
Staphylococcus aureus subsp.
aureus ATCC 25923 (00034*)		 50-100 good
Staphylococcus aureus subsp.
aureus ATCC 6538 (00032*)		 50-100 good
**Bacillus spizizenii
ATCC 6633 (00003*)		 50-100 good
^Pseudomonas paraeruginosa
ATCC 9027 (00026*)		 50-100 good
Candida albicans
ATCC 10231 (00054*)		 50-100 good
#Aspergillus brasiliensis
ATCC 16404 (00053*)		 50-100 good
Clostridium sporogenes
ATCC 19404		 50-100 good

Key: (*) Corresponding WDCM numbers,
^ Formerly known as Pseudomonas aeruginosa
** Formerly known as Bacillus subtilis subsp. spizizenii
# Formerly known as Aspergillus niger

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 (2,3).

More Information
Product Name Diluting Fluid K
SKU LQ122C
Customized Product Available No
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