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Technical Data
Soyabean Casein Digest Medium (Tryptone Soya Broth) M011
Intended Use:
Recommended as a general purpose medium used for cultivation of a wide variety of microorganisms and recommended for
sterility testing of moulds and lower bacteria.
Composition**
Ingredients g/L
Tryptone 17.000
Soya peptone 3.000
Sodium chloride 5.000
Dextrose (Glucose) 2.500
Dipotassium hydrogen phosphate 2.500
Final pH ( at 25°C) 7.3±0.2
**Formula adjusted, standardized to suit performance parameters
Directions
Suspend 30.0 grams in 1000 ml purified/ distilled water. Heat if necessary to dissolve the medium completely. Mix well and
dispense in tubes or flasks as desired. Sterilize by autoclaving at 15 lbs pressure (121°C) for 15 minutes.
Note: If any fibres are observed in the solution, it is recommended to filter the solution through a 0.22 micron filter to eliminate
the possibility of presence of fibres.
Principle And Interpretation
Soyabean Casein Digest Medium is recommended by various pharmacopeias as a sterility testing and as a microbial limit
testing medium (1,2,3). This medium is a highly nutritious medium used for cultivation of a wide variety of organisms (4).
The combination of Tryptone and soya peptone makes the medium nutritious by providing nitrogenous, carbonaceous
substances, amino acids and long chain peptides for the growth of microorganisms. Dextrose/glucose serve as the
carbohydrate source and dibasic potassium phosphate buffer the medium. Sodium chloride maintains the osmotic balance of
the medium.
Type of specimen
Pharmaceutical samples, Clinical samples - urine, pus, wound samples.
Specimen Collection and Handling
For clinical samples, follow appropriate techniques for handling specimens as per established guidelines (5,6).
For pharmaceutical samples, follow appropriate techniques for sample collection, processing as per pharmaceutical
guidelines (2). After use, contaminated materials must be sterilized by autoclaving before discarding.
Warning and Precautions
In Vitro diagnostic Use. For professional use only. 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 clinical specimens. Safety guidelines may be referred in individual safety data sheets.
Limitations
1. Biochemical characterization is necessary to be performed on colonies from pure cultures for further identification.
2. This medium is general purpose medium and may not support the growth of fastidious organisms.
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
Cream to yellow homogeneous free flowing powder
Please refer disclaimer Overleaf.
HiMedia Laboratories Technical Data
Colour and Clarity of prepared medium
Light yellow coloured clear solution without any precipitate.
Reaction
pH of 3.0% w/v aqueous solution at 25°C (after sterilization). pH : 7.3±0.2
pH
7.10-7.50
Stability test
Light yellow coloured clear solution without any precipitation or sedimentation at room temperature for 7 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 not more
than 100 cfu (at 30-35°C for 18-24 hours for bacteria and 5days for fungal) Growth promotion is carried out as per USP/
EP/BP/JP/IP.
Organism Inoculum Growth Incubation Incubation
(CFU) temperature period
Salmonella Typhimurium 50 -100 luxuriant 30 -35 °C 18 -24 hrs
ATCC 14028 (00031*)
Salmonella Abony 50 -100 luxuriant 30 -35 °C 18 -24 hrs
NCTC 6017 (00029*)
^Pseudomonas 50 -100 luxuriant 30 -35 °C 18 -24 hrs
paraeruginosa ATCC 9027
(00026*)
Staphylococcus aureus subsp.
aureus ATCC 50 -100 luxuriant 30 -35 °C 18 -24 hrs
6538 (00032*)
Escherichia coli ATCC 50 -100 luxuriant 30 -35 °C 18 -24 hrs
25922 (00013*)
Escherichia coli
50 -100 luxuriant 30 -35 °C 18 -24 hrs
ATCC 8739 (00012*)
** Bacillus spizizenii 50 -100 luxuriant 30 -35 °C 18 -24 hrs
ATCC 6633 (00003*)
$ Kokuria rhizophila 50 -100 luxuriant 30 -35 °C 18 -24 hrs
ATCC 9341
Pseudomonas aeruginosa 50 -100 luxuriant 30 -35 °C 18 -24 hrs
ATCC 27853 (00025*)
Candida albicans ATCC 50 -100 luxuriant 20 -25 °C <=5 d
10231 (00054*)
Staphylococcus aureus 50 -100 luxuriant 30 -35 °C 18 -24 hrs
subsp. aureus ATCC
25923 (00034*)
Sterility Testing- Growth
promotion+Validation
Staphylococcus aureus 50 -100 luxuriant 20 -25 °C <=3 d
subsp. aureus ATCC 6538
(00032*)
# Aspergillus brasiliensis 50 -100 luxuriant 20 -25 °C <=5 d
ATCC 16404 (00053*)
Candida albicans ATCC 50 -100 luxuriant 30 -35 °C <=5 d
2091 (00055*)
Staphylococcus aureus 50 -100 luxuriant 20 -25 °C <=3 d
subsp. aureus ATCC
25923 (00034*)
Escherichia coli ATCC 50 -100 luxuriant 20 -25 °C <=3 d
25922 (00013*)
Please refer disclaimer Overleaf.
HiMedia Laboratories Technical Data
^Pseudomonas paraeruginosa 50 -100 luxuriant 20 -25 °C <=3 d
ATCC 9027 (00026*)
** Bacillus spizizenii 50 -100 luxuriant 20 -25 °C <=3 d
ATCC 6633 (00003*)
Salmonella Typhimurium 50 -100 luxuriant 20 -25 °C <=3 d
ATCC 14028 (00031*)
Salmonella Abony NCTC 50 -100 luxuriant 20 -25 °C <=3 d
6017 (00029*)
Escherichia coli ATCC 50 -100 luxuriant 20 -25 °C <=3 d
8739 (00012*)
Pseudomonas aeruginosa
ATCC 27853 (00025*) 50 -100 luxuriant 20 -25 °C <=3 d
$ Kokuria rhizophila 50 -100 luxuriant 20 -25 °C <=3 d
ATCC 9341
Key : (*) Corresponding WDCM numbers
^ Formerly known as Pseudomonas aeruginosa **Formerly known as Bacillus subtilis subsp. spizizenii
# Formerly known as Aspergillus niger $ Formerly known as Micrococcus luteus
Storage and Shelf Life
Store between 10-30°C in a tightly closed container and the prepared medium at 15-30°C. Use before expiry date on the
label. On opening, product should be properly stored dry, after tightly capping the bottle in order to prevent lump
formation due to the hygroscopic nature of the product. Improper storage of the product may lead to lump formation. Store
in dry ventilated area protected from extremes of temperature and sources of ignition Seal the container tightly after use.
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
clinical sample must be decontaminated and disposed of in accordance with current laboratory techniques (5,6).
Reference
1.Indian Pharmacopoeia, 2022, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare Government of
India.
2.MacFaddin J. F., 1985, Media for Isolation-Cultivation-Identification-Maintenance of Medical Bacteria, Vol. 1, Williams
& Wilkins, Baltimore, M.d.
3.The United States Pharmacopoeia-National Formulatory (USP-NF), 2022.
4.Forbes B. A., Sahm D. F. and Weissfeld A. S., 1998, Bailey & Scotts Diagnostic Microbiology, 10th Ed., Mosby, Inc. St.
Louis, Mo.
5.Isenberg, H.D. Clinical Microbiology Procedures Handbook 2nd Edition.
6.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. 1.
Revision : 05/2024
HiMedia Laboratories Pvt. Limited, IVD In vitro diagnostic 30°C Storage temperature
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MIDC, Wagle Industrial Area,
Thane (W) -400604, MS, India
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Disclaimer :
User must ensure suitability of the product(s) in their application prior to use. Products conform solely to the information contained in this and
other related HiMedia™ publications. The information contained in this publication is based on our research and development work and is to the best
of our knowledge true and accurate. HiMedia™ Laboratories Pvt Ltd reserves the right to make changes to specifications and information related
to the products at any time. Products are not intended for human or animal or therapeutic use but for laboratory,diagnostic, research or further
manufacturing use only, unless otherwise specified. Statements contained herein should not be considered as a warranty of any kind, expressed or
implied, and no liability is accepted for infringement of any patents.
HiMedia Laboratories Pvt. Ltd. Corporate Office : Plot No.C-40, Road No.21Y, MIDC, Wagle Industrial Area, Thane (W) - 400604, India.
Customer care No.: 022-6147 1919 Email: techhelp@himedialabs.com Website: www.himedialabs.com
