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 Gms / Litre
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
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 Growth Incubation
period
Inoculum
(CFU)
Incubation
temperature
Salmonella Typhimurium
ATCC 14028 (00031*)
50 -100 luxuriant 30 -35 °C 18 -24 hrs
Salmonella Abony
NCTC 6017 (00029*)
50 -100 luxuriant 30 -35 °C 18 -24 hrs
Pseudomonas aeruginosa
ATCC 9027 (00026*)
50 -100 luxuriant 30 -35 °C 18 -24 hrs
Streptococcus pneumoniae
ATCC 6305
50 -100 luxuriant 30 -35 °C 18 -24 hrs
Staphylococcus aureus
subsp. aureus ATCC
6538 (00032*)
50 -100 luxuriant 30 -35 °C 18 -24 hrs
Escherichia coli ATCC
25922 (00013*)
50 -100 luxuriant 30 -35 °C 18 -24 hrs
Escherichia coli NCTC 9002 50 -100 luxuriant 30 -35 °C 18 -24 hrs
Escherichia coli
ATCC 8739 (00012*)
50 -100 luxuriant 30 -35 °C 18 -24 hrs
Bacillus subtilis
subsp. spizizenii
ATCC 6633 (00003*)
50 -100 luxuriant 30 -35 °C 18 -24 hrs
Micrococcus luteus ATCC
9341
50 -100 luxuriant 30 -35 °C 18 -24 hrs
Pseudomonas aeruginosa
ATCC 27853 (00025*)
50 -100 luxuriant 30 -35 °C 18 -24 hrs
Candida albicans ATCC
10231 (00054*)
50 -100 luxuriant 20 -25 °C =5 d
Staphylococcus aureus
subsp. aureus ATCC
50 -100 luxuriant 30 -35 °C 18 -24 hrs
50 -100 luxuriant 20 -25 °C =3 d
Candida albicans ATCC
2091 (00055*)
50 -100 luxuriant 30 -35 °C =5 d
Staphylococcus aureus
subsp. aureus ATCC
50 -100 luxuriant 20 -25 °C =3 d
25923 (00034*)
Escherichia coli ATCC
25922 (00013*)
50 -100 luxuriant 20 -25 °C =3 d
25923 (00034*)
Sterility Testing- Growth
promotion+Validation
Staphylococcus aureus
subsp. aureus ATCC 6538
(00032*)
# Aspergillus brasiliensis
ATCC 16404 (00053*)
50 -100 luxuriant 20 -25 °C =5 d
HiMedia Laboratories Technical Data
Bacillus subtilis subsp.
spizizenii
ATCC 6633 (00003*)
50 -100 luxuriant 20 -25 °C =3 d
Salmonella Typhimurium
ATCC 14028 (00031*)
50 -100 luxuriant 20 -25 °C =3 d
Salmonella Abony NCTC
6017 (00029*)
50 -100 luxuriant 20 -25 °C =3 d
Streptococcus pneumoniae
ATCC 6305
50 -100 luxuriant 20 -25 °C =3 d
Escherichia coli
ATCC 8739 (00012*)
50 -100 luxuriant 20 -25 °C =3 d
Escherichia coli NCTC 9002 50 -100 luxuriant 20 -25 °C =3 d
Pseudomonas aeruginosa
ATCC 27853 (00025*)
50 -100 luxuriant 20 -25 °C =3 d
Micrococcus luteus ATCC
9341
50 -100 luxuriant 20 -25 °C =3 d
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 : 04/2022
Key : (#) Formerly known as Aspergillus niger, (*) Corresponding WDCM numbers
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.
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
clinical sample must be decontaminated and disposed of in accordance with current laboratory techniques (3,4).
Reference
Please refer disclaimer Overleaf.
Pseudomonas aeruginosa
ATCC 9027 (00026*)
50 -100 luxuriant 20 -25 °C =3 d
