-cm H2O
not less than 100µg/ml, which can then be further diluted to
other aqueous solutions. Recombinant Human Insulin
Certificate of Analysis and Data Sheet
Description: Recombinant Human Insulin produced in
E.Coli is a two chain, non-glycosylated polypeptide
chain containing 51 amino acids and having a molecular
mass of 5807 Dalton.
rHuInsulin is purified by
proprietary chromatographic techniques.
Source: Escherichia Coli.
Physical Appearance:Sterile Filtered White lyophilized (freeze-dried) powder.
Formulation & Packaging: The protein was lyophilized from a concentrated (1mg/ml) solution with no additives.
Solubility: It is recommended to
reconstitute the lyophilized rHuInsulin in sterile 18M-cm H2O
not less than 100µg/ml, which can then be further diluted to
other aqueous solutions.
Stability: Lyophilized rHuInsulin
although stable at room temperature for 3 weeks, should be
stored desiccated below -18
C. Upon reconstitution
rHuInsulin should be stored at 4 C between 2-7 days and
for future use below -18 C.
For long term
storage it is recommended to add a carrier protein (0.1% HSA
or BSA).
Please prevent freeze-thaw cycles.
Purity: Greater than 98.0% as determined
by:
(a) Analysis by RP-HPLC.
(b) Anion-exchange
FPLC.
(c) Analysis by reducing and non-reducing SDS-PAGE
Silver Stained gel.
Dimers and aggregates: Less than 1% as determined by silver-stained SDS-PAGE gel analysis.
Biological Activity: Our rHuInsulin is fully biologically active when compared to World Health Organization (WHO) reference standard which is 28 units/mg.
Endotoxin: Less than 0.1 ng/µg (IEU/µg) of rHuInsulin.
Protein content: Protein quantitation was carried out by two independent methods:
1. UV spectroscopy at 280 nm.
2. Analysis by RP-HPLC, using a calibrated solution of Insulin as a Reference Standard.
Usage: This material is offered for research, laboratory or further manufacturing purposes.
Send e-mail to:
customer_service@abazyme.com with questions or comments.
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