agency
EP 2.6.13
description
For the microbial examination of non-sterile pharmaceuticals in the presence of disinfectant residues
sterility
sterile; autoclaved
form
liquid
shelf life
12 mo.
feature
closure type White screw cap for wide neck, ready-to-use
composition
Histidine , Lecithin, 3 g , Tween®
packaging
pack of 6 bottles
technique(s)
direct inoculation: suitable, sterile filtration: suitable
bottle capacity
275 mL
bottle filling volume
90 mL
pH
7.0
Quality Level
application(s)
bioburden testing
cosmetics
food and beverages
pharmaceutical
storage temp.
2-25°C
suitability
nonselective for
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General description
Buffered NaCl-Peptone Solution has a low content of peptone, along with phosphate buffer and sodium chloride, to maintain the viability of present microorganisms without supporting their growth. The neutralizing additives lecithin, polysorbate (Tween®) 80, and histidine reverse the growth inhibitory effect of most disinfectants and antiseptics. Histidine shows neutralizing efficiency against formaldehyde and formaldehyde-releasing agents. Lecithin in combination with Tween® 80 is effective against quaternary ammonium compounds, amphoteric surfactants, benzamidines, chlorhexidines, and dequadin. Tween® 80 inactivates benzyl alcohol, carbanilides, dichlorbenzyl alcohols, benzoic acid, p-hydroxybenzoic acid, and its esters, phenols, phenylethyl alcohols, and solbrols (PHB esters).
Application
Buffered NaCl-Peptone Solution with neutralizers is designed for the microbial examination of non-sterile pharmaceutical products in the presence of disinfectant residues.
Features and Benefits
Our ready to use media provide the highest level of quality and testing confidence. They have been formulated and tested to meet the pharmacopoeia requirements. Sterility testing media and rinse solutions are manufactured in an ISO 9001, environmentally controlled production center. Each lot undergoes a stringent quality control (QC) procedure, including pH, sterility and growth promotion tests. Our manufacturing approach ensures the highest level of clarity for our media and rinsing fluids, therefore improving accuracy and significantly reducing the risk of incorrect interpretation and false results.
Legal Information
TWEEN is a registered trademark of Croda International PLC
저장 등급
10 - Combustible liquids
wgk
WGK 1
시험 성적서(COA)
제품의 로트/배치 번호를 입력하여 시험 성적서(COA)을 검색하십시오. 로트 및 배치 번호는 제품 라벨에 있는 ‘로트’ 또는 ‘배치’라는 용어 뒤에서 찾을 수 있습니다.
국제 무역 품목 번호
| SKU | GTIN |
|---|---|
| 1.46522.0006 | 04027269265014 |
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