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Material Safety Data Sheet

Organisms

Organisms in the Clinical sector this product works with:

Dehydrated Culture Media

Sector: Clinical

SABOURAUD LIQUID MEDIUM (Sabouraud-dextrose broth) EP/USP/JP/BP

Code: CM0147

a liquid medium recommended for sterility testing, for non-sterile testing and for the determination of the fungistatic activity of pharmaceutical products

Formula

gm/litre

Dextrose 

20.0

Pancreatic digest of casein

5.0

Peptic digest of animal tissue

5.0

pH 5.6 ± 0.2 @ 25°C

 

 

Directions
Dissolve 30g in 1 litre of water (purified as required). Mix well, distribute into final containers and sterilise by autoclaving at 121°C for 15 minutes.

Description

Sterile products
Sabouraud Dextrose Liquid Medium is a mycological sterility test medium conforming to the medium described in the USP1 for the determination of the fungistatic activity of pharmaceutical and cosmetic products in order to avoid false sterility tests.

Non-sterile products
A suitable medium for the isolation of Candida albicans. Sabouraud Dextrose Liquid Medium conforms to the parameters from the harmonised EP/USP/JP Microbial Limit Testing for the microbial enumeration tests and tests for specified microorganisms 2,3.

In clinical microbiology, the use of Sabouraud Dextrose Liquid Medium has been shown to increase the isolation rate of Candida albicans in blood culture4.

The medium may also be used for the cultivation of acidophilic bacteria.

Technique

Sterile products
The USP recommends that the fungistatic activity of pharmaceutical products be determined as follows:

  1. Test culture
    A 1 in 1,000 dilution of a 24-28 hour culture of Candida albicans in Sabouraud Dextrose Liquid Medium and inoculate with the Test Culture.
  2. Tests
    Add specified amounts of the product to be tested to volumes of Sabouraud Dextrose Liquid Medium and inoculate with the Test Culture.
  3. Controls
    Inoculate tubes of Sabouraud Dextrose Liquid Medium only, with the Test Culture.
  4. Incubate at 22-25°C for at least 10 days.
  5. If growth in the test series is comparable to that in the control tubes, then the product is not fungistatic - therefore use the amount of product and medium specified for all routine sterility tests on the product.

    If the product is fungistatic when tested as above, add a suitable sterile inactivating reagent, or, use a larger ratio of medium to product in order to determine the ratio of product to medium in which growth of the test organism is not affected.

Non-sterile products

Microbial Enumeration Tests
Grow Candida albicans in Sabouraud Dextrose Liquid Medium. Incubate at 20-25°C for 2-3 days. Use this micro-organim for growth promotion and suitability of the counting method in the presence of the product.

Tests for specified micro-organisms
Prepare the product to be examined as described in EP general chapter 2.6.12 (Harmonised method) and use 10ml or the quantity corresponding to not less than 1g or 1ml to inoculate 100ml of Sabouraud Dextrose Liquid Medium and mix. Incubate at 30-35°C for 3-5 days. Subculture on a plate of Sabouraud Dextrose Agar (R454462), and incubate at 30-35°C for 24-48 hours.

Additional information about this and other products in our harmonised range can be obtained by downloading our Harmonised Culture Media Portfolio.

Storage conditions and Shelf life
Store the dehydrated medium at 10-30°C and use before the expiry date on the label.
Store the prepared medium away from light between 2-25°C.

Appearance
Dehydrated medium: Light straw coloured, free-flowing powder
Prepared medium: Straw coloured solution

Quality control sterile pharmaceutical products 

Positive controls:

Expected results

Candida albicans ATCC® 10231*Turbid growth
Aspergillus niger ATCC® 9642*

Surface growth; white mycelia with or without black spores

Negative control:

 

Uninoculated medium

No change

* This organism is available as a Culti-Loop®

Quality control non-sterile pharmaceutical products

Enumeration

Positive control:

Expected result

Candida albicans ATCC® 10231*Turbid growth


Test for specified micro-organisms 

Positive control:

Expected result

Candida albicans ATCC® 10231*Turbid growth
 * This organism is available as a Culti-Loop®

References
1. US Pharmacopoeia 30 (2008).
2. European Pharmacopoeia 6.1. 2.6.12 Microbiological Examination of Non-Sterile Products: Harmonised Method: Microbial Enumeration tests 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified Micro-organisms. B. Harmonised Method. (2008).
3. Japanese Pharmacopoeia. 15 th Edition. (2006).
4. Reeder J.C., Ganguli L.A., Drucker D.B., Keaney M.G.L. and Gibbs A.C.C. (1989) Microbios. 60. 71-77.

 
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