>10 U/mL in water
Beta-lactamases are enzymes produced by bacteria (Also known as Penicillinase) that provide resistance to β-lactam antibiotics such as penicillins, cephamycins, and carbapenems (ertapenem), although carbapenems are relatively resistant to beta-lactamase. Beta-lactamase provides antibiotic resistance by breaking the antibiotics structure.
These antibiotics all have a common element in their molecular structure: a four-atom ring known as a β-lactam. Through hydrolysis, the lactamase enzyme breaks the β-lactam ring open, deactivating the molecule's antibacterial properties.Beta-lactam antibiotics are typically used to treat a broad spectrum of Gram-positive and Gram-negative bacteria. Beta-lactamases produced by Gram-negative organisms are usually secreted, especially when antibiotics are present in the environment.
β-LACTAMASE is a freeze-dried product containing buffer salts and zinc. β-LACTAMASE-BS has a broad spectrum activity of complete inactivation over a broad range of cephalosporins and penicillins.
• Full inactivation of a broad range of Beta-Lactams including the more resistant cephalosporins: Cefepime, Cefoxitin, Cefradine and Ceftazidime which other commercially available enzymes do not degrade as efficiently.
• Highly stable, retaining >90% of its activity after 4 hours at 50°C, means no need to compensate for loss of enzyme activity during media preparation for applications using sterile plates.
• Testing sterility of blood cultures - Blood cultures are routinely prepared in order to test for bacterial infection. False negative results might be obtained where the blood sample contains antibiotics. Incorporation of β-Lactamase in the culture medium will overcome this problem when cephalosporins/penicillins are present.
• Testing for contamination of drugs by antibiotics - US Code of Federal regulations states that “If a reasonable possibility exists that a non-penicillin drug product has been exposed to cross-contamination with penicillin, the non-penicillin drug product shall be tested for the presence of penicillin” (21 CFR 211.176, Penicillin Contamination, FDA, BY-Lines No. 8 November 1977).
• Environmental monitoring of antibiotic manufacturing area.
• Sterility testing of Bulk antibiotics as described by US Pharmcopeia (USP) Chapter 71 and EP Section 2.6.
• Sterile, ready to use vials: >50 units/vial
• Non-sterile, bulk: >2 U/mg powder
• Sterile, gamma-irradiated, pre-dispensed, vacuum sealed vials (in packs of 10) for speed and ease of use
• 1 KU is approximately 0.31 g
• 1 Vial is approximately 30-50 mg
• pH Activity Range: Active at ph 6.5 - 9.8
• Temperature stability: >90% at 50°C for 4 hours
• Bulk powder is not sterile, but has been filtered through a 0.45 micron filter prior to freeze drying.
Reconstitution Protocol for Sterile, Ready to Use Vials
Reconstitute at 10 U/mL with sterile water. Sterile-filter through a 0.45 μm membrane filter into sterile media. For agar media, add to liquid agar medium at >40°C just prior to pouring agar plates.
• Potency in Agar Medium: Use at 0.5 U/mL in agar plates for complete (100%) hydrolysis of all Beta-lactams.
• One unit of Beta-Lactamase activity is defined as the amount of enzyme that will catalyze the hydrolysis of 1.0 micromole of cephalosporin C per minute at 25°C and pH 7.0
• One Beta-Lactamase unit is equivalent to 600 Levy Units, 75 Pollock Units, or 91200 Kersey Kinectic Units
• Beta-Lactamase vials are sterilized by gamma-irradiation. No detectable growth in Tryptone Soya broth at 20°C to 25°C or Thioglycollate at 30°C to 35°C for 14 days.
• Bulk powder is not sterile, but has been filtered through at 0.45 micron filter prior to freeze drying.
Not for human therapeutic use or for medicinal purposes. For research applications only.
Research or further manufacturing use only, not for food or drug use.