Characteristics

Specifications

Test

Visual appearance

Clear, colourless solution

Visual inspection

DNA homogeneity

>95 supercoiled form

Agarose gel electrophoresis

Sterility (pre-clinical grade only)

Sterile (absence of microorganisms)

Bioburden assay

DNA concentration

0.5-1 mg/ml or as specified by the client

Absorption at 260 nm

DNA identity

Co-migrates with standard or as specified by client

Restriction analysis Agarose gel electrophoresis

Purity

1.7-2 A260/280

Optical density measurements

Presence of genomic DNA

<5% (<0.05mg/mg of plasmid)

Agarose gel electrophoresis

Presence of RNA and ssDNA

Undetectable

Agarose gel electrophoresis

Presence of endotoxin

<0.1 EU/mg plasmid DNA

LAL test

Presence of protein (pre-clinical grade only)

<1%

BCA assay