Ready-to-use media
Buffered Peptone Water 0,1% EP/USP/ISO
Diluent for the homogenization of samples for the microbiological examination according to the European Pharmacopeial Harmonised Method and ISO standard.
- Cat. No.
- LC-4035
- Category
- Ready-to-use media
- Formats
- 3 formats
- ISO 17025 quality control
- Yes
- Storage
- 8 to 25 °C
- Standards
- European PharmacopoeiaISO 21149USP
- Also available
- Ready-to-use medium, 3 formats (LC-5154)
Diluent and non-selective pre-enrichment medium that has the property of revitalization of the peptone water and the pH change absorbing capacity of phosphate buffer.
Key features
Applications
Diluent (general use).
Industry
Cosmetics, final product quality control, pharmaceutical/veterinary.
Standards
European Pharmacopoeia, ISO 21149, USP.
Testing
Analytical methodology according to ISO 11133:2014/Amd 1:2018; A2:2020.
Description and technique
Inoculate according to final purpose, samples and validated methods.
LC-4638, bottles
This solution is recommended by the European Pharmacopoeia to dilute samples for microbiological examination.
Use the medium according to intended purposes, samples and validated methods.
Presentation
| Code | Presentation | Filling | Packaging |
|---|---|---|---|
| LC-4035 | 20 tubes, 16 x 113 mm | 9 ± 0.2 mL | 1 box with 20 tubes, 16 x 113 mm glass tubes, ink labelled and metal non-injectable cap. |
| LC-4037 | 20 tubes, 16 x 113 mm | 10 ± 0.2 mL | 1 box with 20 tubes, 16 x 113 mm glass tubes, ink labelled and metal non-injectable cap. |
| LC-4638 | 10 prepared bottles, 125 mL | 90 ± 3 mL | 1 box with 10 bottles 125 mL. Injectable cap: plastic screw inner cap. The use of syringe needles with a diameter greater than 0.8 mm is not recommended. |
Composition
| Ingredient | g/L |
|---|---|
| Casein peptone | 1.00 |
| Sodium chloride | 4.30 |
| Disodium hydrogen phosphate dihydrate (1) | 7.20 |
| Potassium dihydrogen phosphate (2) | 3.60 |
(1) Equiv. to disodium phosphate dihydrate.
(2) Equiv. to monopotassium phosphate.
LC-4037 (tubes) and LC-4638 (bottles)
| Ingredient | g/L |
|---|---|
| Peptone | 1.00 |
| Sodium chloride | 4.30 |
| Disodium phosphate dihydrate | 7.23 |
| Potassium dihydrogen phosphate | 3.60 |
Quality control
Physical/chemical control
| Color | Colourless |
|---|---|
| pH | 7.0 ± 0.2 at 25 °C |
Microbiological control
Inoculate ≤ 10³ CFU/tube (productivity) / subculture after holding at 20-25 °C for 45 min to 1 h.
Growth Promotion Test 50-100 CFU according to harmonized Pharmacopoeia monographs (EP) and test methods & ISO 11133:2014/Amd 1:2018.
Analytical methodology according to ISO 11133:2014/Amd 1:2018; A2:2020.
Aerobic. Incubation at 30-35 °C for 18-72 h (bacteria) and 20-25 °C for 3-5 days (moulds and yeast).
| Microorganism | Growth |
|---|---|
| Ps. aeruginosaATCC 9027, WDCM 00026 | Good. Recovery ± 30% T0 (original enumeration) |
| Bacillus subtilisATCC 6633, WDCM 00003 | Good. Recovery ± 30% T0 (original enumeration) |
| Escherichia coliATCC 8739, WDCM 00012 | Good. Recovery ± 30% T0 (original enumeration) |
| Salmonella typhimuriumATCC 14028, WDCM 00031 | Good. Recovery ± 30% T0 (original enumeration) |
| Candida albicansATCC 10231, WDCM 00054 | Good. Recovery ± 30% T0 (original enumeration) |
| Staphylococcus aureusATCC 6538, WDCM 00032 | Good. Recovery ± 30% T0 (original enumeration) |
| L. monocytogenesATCC 13932, WDCM 00021 | Good. Recovery ± 30% T0 (original enumeration) |
| Aspergillus brasiliensisATCC 16404, WDCM 00053 | Good. Recovery ± 30% T0 (original enumeration) |
LC-4037 and LC-4638: microbiological control
LC-4037: prepare tubes - inoculate: practical range 10-100 CFU (productivity) according to harmonized Eur. Pharmacopoeia. Subculture in appropriate culture media after T0 (inoculum), 45 min - 1 h at 20-25 °C.
LC-4638: prepare tubes / inoculate 10³-10⁴ (productivity) / subculture after holding at 20-25 °C for 45 min to 1 h.
Aerobiosis. Incubation at 35 ± 2 °C, reading after 18-24 hours.
| Microorganism | Growth |
|---|---|
| Bacillus subtilisATCC 6633, WDCM 00003 | Good. Recovery ± 30% T0 (original enumeration) |
| Staphylococcus aureusATCC 6538, WDCM 00032 | Good. Recovery ± 30% T0 (original enumeration) |
| Escherichia coliATCC 8739, WDCM 00012 | Good. Recovery ± 30% T0 (original enumeration) |
| Candida albicansATCC 10231, WDCM 00054 | Good. Recovery ± 30% T0 (original enumeration) |
| Ps. aeruginosaATCC 9027, WDCM 00026 | Good. Recovery ± 30% T0 (original enumeration) |
| Salmonella typhimuriumATCC 14028, WDCM 00031 | Good. Recovery ± 30% T0 (original enumeration) |
Sterility control
Incubation 48 h at 30-35 °C and 48 h at 20-25 °C: NO GROWTH.
Check at 7 days after incubation in same conditions.
Bibliography
- COLIPA (1997) Guidelines on Microbial Quality Management (MQM). Brussels.
- EUROPEAN PHARMACOPOEIA 8.0 (2014) 8th ed. § 2.6.13. Microbiological examination of non-sterile products: Test for specified microorganisms. Harmonised Method. EDQM. Council of Europe. Strasbourg.
- ISO 11133:2014/Amd 1:2018. Microbiology of food, animal feed and water. Preparation, production, storage and performance testing of culture media.
- ISO 16212 Standard (2017) Cosmetics - Microbiology - Enumeration of yeast and mould.
- ISO 21149 Standard (2017) Cosmetics - Microbiology - Enumeration and detection of aerobic mesophilic bacteria.
- ISO 21150 Standard (2015) Cosmetics - Microbiology - Detection of Escherichia coli.
- ISO 22717 Standard (2015) Cosmetics - Microbiology - Detection of Pseudomonas aeruginosa.
- ISO 22718 Standard (2015) Cosmetics - Microbiology - Detection of Staphylococcus aureus.
- USP 33 - NF 28 (2011) <62> Microbiological examination of non-sterile products: Test for specified microorganisms. Harmonised Method. USP Corp. Inc. Rockville. MD. USA.
What you receive
The product
Shipped under controlled temperature when the product requires it.
Lot certificate
Every lot comes with its certificate.
Tracked shipment
Follow your shipment live, from our warehouse to your lab.
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Frequently asked questions
Can I ask for formats other than those listed?
Yes: custom formats and OEM packs are available on request. Tell us the quantities you need.
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How long does delivery take?
We give you the availability with the quote, within 24 hours of your request.