CERTIFICATE OF ANALYSIS
AMBICIN® L (RECOMBINANT LYSOSTAPHIN)


Gene: Lysostaphin gene from Staphylococcus simulans, Genbank accession numbers M15686 and I00376
Expression organism: E. coli
Activity assay: Determined by the decrease in turbidity of a suspension of heat-killed Staphylococcus aureus 8325-4 at pH 8.0, 30° C (AMBI Protocol TP-031). Specific activity is measured relative to an AMBI lysostaphin standard with a defined activity of 4,000 U/mg
Storage conditions:
Long-term: Store in sealed container with desiccant at -20° C.

Solution: Stable for at least 6 months when stored at 4°C as 10 mg/ml solution in 20 mM sodium acetate, pH 4.5, in a polypropylene container.
Method of analysis: Reverse phase HPLC monitored at 210 nm (AMBI Protocol TP-112.M)
Peptide purity: >90% (reverse phase HPLC)
mg protein/mg solid: >0.9 (Absorbance at 280 nm; extinction coefficient = 2.02 AU/mg/ml)
Additives: None
Specific activity: >3,000 units/mg (Turbidometric assay AMBI Protocol TP-031)
Physical form: Lyophilized powder
Shelf life: <1% loss of activity per year, when stored dry at -80° C
 
Batch Information  
Lot Number: GDV1
Specific activity: 3552 units/mg
Peptide purity: 93.4% (HPLC, % of peak area)