Soyabean Casein Digest Medium

SKU:
LQ027
Availability: In stock
Only %1 left
As low as $64.00


Intended Use

Sterility test media prepared in accordance with harmonized methods of USP, EP, BP, JP & IP.

Composition**

Ingredients g/L
Tryptone$ 17.000
Soya peptone^ 3.000
Sodium chloride 5.000
Glucose monohydrate 2.500
Dipotassium hydrogen phosphate 2.500
Final pH after sterilization (at 25°C) 7.3±0.2

**Formula adjusted, standardized to suit performance parameters

$ Equivalent to Pancreatic digest of casein

^ Equivalent Papaic digest of soyabean meal

Directions

Label the ready to use LQ027 bottle. Inoculate the sample and Incubate at specified temperature and time.

Principle And Interpretation

Soyabean Casein Digest Medium is recommended as a sterility testing medium in accordance with the harmonized method of USP/EP/BP/JP/IP (1-5). It is used for the sensitivity testing of antimicrobial agents by the tube dilution method (6). It is also employed in diagnostic research in microbiology. This medium is used as a diluent and suspending medium for preparation of samples or test strains. It is also employed in sample preparation for testing of products, wherein incubation is carried out, only to serve sufficient resuscitation of the cell, while avoiding multiplication of the organism. Tryptone and soya peptone makes this medium nutritious by providing nitrogeneous and carbonaceous compounds, long chain peptides, vitamins and other essential nutrients for the growth of microorganisms. Natural sugars in soybean promote growth of fastidious organism. Glucose monohydrate is the fermentable source of carbon and dibasic potassium phosphate serves as the buffer in the medium. Sodium chloride maintains the osmotic balance of the medium. This medium is recommended for sterility checking and for studying total aerobic microbial count in verification of microbiological testing procedures employed for sterility checking.

Type of specimen

Pharmaceutical samples

Specimen Collection and Handling

For pharmaceutical samples, follow appropriate techniques for sample collection, processing as per 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. Biochemical characterization is necessary to be performed on colonies from pure cultures for further identification.
  2. Individual organisms differ in their growth requirement and may show variable growth patterns on the medium.
  3. 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 Soyabean Casein Digest medium in a glass bottle.

Colour
Light yellow coloured clear solution

Quantity of Medium
100 ml of medium in glass bottle.

pH
7.10-7.50

Growth Promotion Test
In accordance with the harmonized method of USP/EP/BP/JP.

Sterility Check
Passes release criteria.

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 18-24 hours for bacteria). Growth promotion is carried out as per USP/EP/BP/JP.

Sterility Testing + Validation
The medium is tested with suitable strains of microorganisms inoculating ≤ 100 cfu and incubating at 20-25°C for not more than 3 days in case of bacteria and not more than 5 days in case of fungi.

Organism Inoculum (CFU) Growths Incubation period Incubation temperature
Growth promoting
Salmonella Abony NCTC 6017 (00029*) ≤ 100 luxuriant 18-24 hrs 30-35 °C
Salmonella Typhimurium ATCC 14028 (00031*) ≤ 100 luxuriant 18-24 hrs 30-35 °C
^ Pseudomonas paraeruginosa ATCC 9027 (00026*) ≤ 100 luxuriant 18-24 hrs 30-35 °C
Escherichia coli ATCC 8739 (00012*) ≤ 100 luxuriant 18-24 hrs 30-35 °C
$$ Bacillus spizizeni ATCC 6633 (00003*) ≤ 100 luxuriant 18-24 hrs 30-35 °C
## Kokuria rhizophila ATCC 9341 ≤ 100 luxuriant 18-24 hrs 30-35 °C
Staphylococcus aureus subsp. aureus ATCC 6538 (00032*) ≤ 100 luxuriant 18-24 hrs 30-35 °C
Sterility Testing- Growth promotion+Validation
^ Pseudomonas paraeruginosa ATCC 9027 (00026*) ≤ 100 luxuriant <=3 d 20-25 °C
$$Bacillus spizizenii ATCC 6633 (00003*) ≤ 100 luxuriant <=3 d 20-25 °C
Staphylococcus aureus subsp. aureus ATCC 6538 (00032*) ≤ 100 luxuriant <=3 d 20-25 °C
##Kokuria rhizophila ATCC 9341 ≤ 100 luxuriant <=3 d 20-25 °C
Candida albicans ATCC 10231 (00054*) ≤ 100 luxuriant <=5 d 20-25 °C
#Aspergillus brasiliensis ATCC 16404 (00053*) ≤ 100 luxuriant <=5 d 20-25 °C

Key:

  • (*) Corresponding WDCM numbers,
  • # - Formerly known as Aspergillus niger,
  • ^ Formerly known as Pseudomonas aeruginosa
  • $ - Luxuriant growth refers to turbid growth
  • ## - Formerly known as Micrococcus luteus
  • $$ - Formerly known as Bacillus subtilis subsp. spizizenii

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 (7,8).

More Information
Product Name Soyabean Casein Digest Medium
SKU LQ027
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What is Soyabean Casein Digest Medium, and how is it used in sterility testing?

Soyabean Casein Digest Medium (SCDM), also known as Tryptone Soya Broth (TSB), is a nutrient-rich, non-selective medium that supports the growth of a wide range of **aerobic bacteria and fungi**. In sterility testing, the product sample is added to SCDM and incubated under specified conditions. If viable microorganisms are present, they multiply and may produce visible growth or turbidity. Therefore, SCDM helps detect microbial contamination in products intended to be sterile.

How should Soyabean Casein Digest Medium be stored to maintain its efficacy?

For dehydrated media, store at 10–30°C in a cool, dry place with the container tightly closed to prevent moisture absorption. Protect the media from direct sunlight and extreme temperatures. Prepared media should generally be stored at 15–30°C and used promptly in accordance with validated laboratory procedures. Before use, inspect the media for turbidity after rehydration and complete dissolution, as well as for particles, discoloration, or signs of contamination. Perform Growth Promotion Testing (GPT), as required, to confirm satisfactory microbial growth performance.

What are the safety precautions for handling Soyabean Casein Digest Medium?

Wear appropriate personal protective equipment (PPE), including a lab coat, gloves, and safety glasses, when preparing and handling the medium. Handle dehydrated powder inside a fume hood to minimize dust inhalation. Use heat-resistant gloves when handling hot, autoclaved flasks and allow the medium to cool to 45–50°C before dispensing. Close media containers tightly immediately after use to prevent moisture absorption and contamination.

When inoculating microorganisms, work in a biosafety cabinet or laminar flow hood, as appropriate. Treat all used media and test samples as potentially infectious and dispose of them as biohazardous waste in accordance with local regulations. Use dedicated tools to minimize cross-contamination, disinfect work surfaces before and after use, and follow the laboratory’s established spill-response procedures.

What are the main components and their functions in Soyabean Casein Digest Medium?

Soyabean Casein Digest Medium (SCDM) contains nutrients that support the growth of a wide range of microorganisms. Tryptone, a pancreatic digest of casein, provides amino acids, peptides, and nitrogen required for microbial growth. Soya peptone, supplies additional proteins, carbohydrates, and growth factors that support a wide range of microorganisms. Dextrose provides an accessible source of carbon and energy, while dipotassium phosphate helps maintain pH stability. Sodium chloride maintains osmotic balance, creating a nutrient-rich environment suitable for the growth of diverse group of microorganisms.

How does Soyabean Casein Digest Medium compare with other similar media in performance?

Soyabean Casein Digest Medium (SCDM) or Tryptone Soya Broth (TSB) is a general-purpose, non-selective medium that provides broad microbial recovery, particularly for aerobic bacteria and fungi. Compared with selective media, it does not contain inhibitory agents, thus allowing a wider range of microorganisms to grow. Its performance is typically evaluated through Growth Promotion Testing (GPT) to confirm consistent microbial recovery. For sterility testing, SCDM is commonly used for the recovery of aerobes and fungi alongside Fluid Thioglycollate Medium (FTM) to provide broader microbial coverage.

What is the intended use of Soyabean Casein Digest Medium?

Recommended as a general-purpose, nutrient-rich medium for cultivating a wide variety of microorganisms. It supports the growth of aerobic bacteria, yeasts, and moulds due to its balanced and highly nutritive composition. It is specifically recommended for sterility testing, particularly for detecting moulds and aerobic bacteria in pharmaceutical products. The medium is suitable for compendial sterility testing procedures requiring reliable recovery of viable microorganisms. It can also be used for sample enrichment as specified in USP Chapter 62, "Test for Specified Microorganisms," as well as routine culture maintenance and general microbiological quality control applications.

What is the composition of Soyabean Casein Digest Medium and what are the functions of its components?

Tryptone at 17.0 g/L, a pancreatic digest of casein, provides amino acids, peptides and nitrogenous nutrients. Soya peptone at 3.0 g/L supplies additional proteins, carbohydrates, vitamins and growth factors for fastidious organisms. Sodium chloride at 5.0 g/L maintains osmotic balance. Dextrose at 2.5 g/L is the carbon and energy source. Dipotassium hydrogen phosphate at 2.5 g/L buffers pH. Final pH is 7.3 ± 0.2 at 25°C.

What are the preparation and sterilization instructions for Soyabean Casein Digest Medium?

Suspend 30.0 g of dehydrated medium in 1000 mL of purified or distilled water. Heat gently if required until completely dissolved, mixing thoroughly for uniform distribution. Dispense into tubes or flasks as the application requires, then sterilise by autoclaving at 121°C and 15 lbs pressure for 15 minutes. If fibres are visible in the solution, filter through a 0.22 micron membrane before use.

How are the results interpreted in Soyabean Casein Digest Medium?

After inoculation and incubation under prescribed conditions, the medium is examined for evidence of microbial growth. - Presence of turbidity or visible growth indicates the presence of viable microorganisms in the test sample. - Clear medium after the specified incubation period suggests absence of detectable aerobic microbial contamination under the test conditions. This straightforward visual assessment makes Soyabean Casein Digest Medium a reliable indicator medium in sterility and microbiological quality control testing.

What are the physical and quality characteristics of Soyabean Casein Digest Medium?

The quality parameters of Soyabean Casein Digest Medium (SCDM) include a cream-to-yellow, homogeneous, free-flowing dehydrated powder, which is also available in granulated form. After preparation, it should produce a light yellow, clear solution without precipitation. The pH of a 2.98% w/v solution after sterilization should be 7.3 ± 0.2 at 25°C. During stability testing, the prepared medium should remain clear and free from sedimentation for up to 7 days when stored at room temperature.

What is the principle of Soyabean Casein Digest Medium?

The principle of Soyabean Casein Digest Medium is to provide a balanced supply of nutrients required for the growth and recovery of a wide range of microorganisms. Tryptone and soya peptone provide amino acids, peptides, nitrogen, and growth factors; dextrose supplies carbon and energy; dipotassium hydrogen phosphate maintains pH stability; and sodium chloride maintains osmotic balance. This nutritive, non-selective formulation supports the recovery and proliferation of aerobic bacteria, yeasts, and moulds present in test samples.