Plot No. C40, Road No. 21Y, MIDC, Wagle Industrial Estate, Thane(W)-400604, MH, India
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Sabouraud Dextrose Broth
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SKU:
LQ120X
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Intended use
Recommended for the enrichment of Candida albicans from pharmaceutical products in accordance with the microbial limit testing by harmonized methodology of USP/EP/BP/JP & IP.
Composition
| Ingredients | g/L |
|---|---|
| Dextrose (Glucose) | 20.000 |
| Mixture of Peptone and Tryptone (1:1)# | 10.000 |
| pH after sterilization (at 25°C) | 5.6±0.2 |
**Formula adjusted, standardized to suit performance parameters
# Mixture of Peptic digest of animal tissue and Pancreatic digest of casein (1:1)
Directions
Label the ready to use LQ120X bottle. Inoculate the sample and Incubate at specified temperature and time.
Principle And Interpretation
Fungi were among the first microorganisms recognized because some of the fruiting structures, such as the mushrooms, are large enough to be seen without a microscope. Fungi can be grouped simply on the basis of morphology as either yeasts or moulds (1). Fungal diseases that occur on the skin, hair and mucous membrane are called superficial mycoses, and the organism that cause them, the dermatophytes (2). Where fungi are to be isolated, it is good practice to use a medium that favors their growth but is not optimal for the growth of bacteria.
Sabouraud Dextrose Broth is a modification of Dextrose Agar described by Sabouraud (3). It is useful for the cultivation of fungi. This medium is in accordance with the harmonized method of USP/EP/BP/JP/IP (4-8) and is recommended for microbiological examination of non-sterile products.
Peptone and Tryptone provides nitrogenous, carbonaceous compounds, long chain amino acids and other essential for the growth of fungi. Dextrose (Glucose) acts as the energy source.
Type of specimen
Pharmaceutical samples
Specimen Collection and Handling
For pharmaceutical samples, follow appropriate techniques for handling specimens as per established guidelines (4-8).
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
- Individual organisms differ in their growth requirement and may show variable growth patterns on the medium.
- Further biochemical and serological tests should be carried out for complete identification.
- Each lot of the medium has been tested for the organisms specified on the COA. It is recommended to users to validate the medium for any specific microorganism other than mentioned in the COA based on the user's unique requirement.
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 Sabouraud Dextrose Broth in bottle
Colour
Light amber coloured clear solution
Quantity of Medium
10 ml of medium in glass bottle
pH
5.40-5.80
Sterility Check
Passes release criteria
Growth Promotion Test
Growth Promotion was observed in accordance with the harmonized method of USP/EP/BP/JP after an incubation at 30-35°C for 3-5 days.
Growth promoting properties
Clearly visible growth of microorganism comparable to that previously obtained with previously tested and approved lot of medium occurs at the specified temperature for not more than the shortest period of time specified inoculating 100 cfu (at 30-35°C for 3-5 days).
Cultural Response
Cultural characteristics observed after incubation at 20-25 °C for 3-5 days.
| Organism | Inoculum (CFU) | Growth | Incubation temperature | Incubation period |
|---|---|---|---|---|
| Candida albicans ATCC 10231 (00054*) | 50-100 | luxuriant | 30-35 °C | <=3 d |
| Growth Promotion + Total Yeast and Mould count | ||||
| Candida albicans ATCC 10231 (00054*) | 50-100 | luxuriant | 20-25 °C | <=5 d |
| # Aspergillus brasiliensis ATCC 16404 (00053*) | 50-100 | luxuriant | 20-25 °C | <=5 d |
Key: (*) Corresponding WDCM numbers (#) Formerly known as Aspergillus niger
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 (9,10).
Reference
- Murray P. R., Baron J. H., Pfaller M. A., Jorgensen J. H. and Yolken R. H., (Ed.), 2003, Manual of Clinical Microbiology
- Pelczar M. J., Jr., Reid R. D., Chan E. C. S., 1977, Microbiology, 4th Edi, Tata McGraw-Hill Publishing Company Ltd, New Delhi.
- Sabouraud, 1892, Ann. Dermatol. Syphilol, 3:1061.
- The United States Pharmacopoeia, 2022, The United States Pharmacopeial Convention,Rockville, MD.
- European Pharmacopoeia, 2020, European Dept. for the quality of Medicine
- British Pharmacopoeia, 2022, The Stationery office British Pharmacopoeia.
- Japanese Pharmacopoeia, 2016.
- Indian Pharmacopoeia, 2022, Govt. of India, the controller of Publication, Delhi, India.
- Isenberg, H.D. Clinical Microbiology Procedures Handbook 2nd Edition.
- Jorgensen, J.H., Pfaller, M.A., Carroll, K.C., Funke, G., Landry, M.L., Richter, S.S and Warnock., D.W. (2015) Manual of Clinical Microbiology, 11th Edition. Vol.
| Product Name | Sabouraud Dextrose Broth |
|---|---|
| SKU | LQ120X |
| Customized Product Available | No |
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