Testing Items | Quality Standard |
Protein Content (BCA) | ≥ ** mg/ml |
Biological activity (specific activity) | **U/mg |
Purity (RP-HPLC) | ≥96% |
Purity (SDS-PAGE) | ≥95% |
Molecular Weight | kDa± kDa |
Endotoxin | <10 EU/mg |
pH | ** |
Ultraviolet spectroscopy | The maximum absorption peak shall be at 278nm±3nm scanning. |
Content of residual extraneous DNA | Content of residual extraneous DNA shall be not more than 10ng/dose |
Content of Residual antibiotics | The preparation must not contain any Activity of residual antibiotics. |
Content of residual Heavy Metal Ni | Content of residual Heavy Metal Ni shall be not more than 2μg/ml. |
Content of residual host bacteria proteins | Content of residual host bacteria proteins shall be not more than 0.10% of total proteins. |
Content of residual Sumo Enzyme | The preparation must not contain any Activity of residual Sumo Enzyme. |
Isoelectric point | The isoelectric point of ** shall be pH**. The profile of the isoelectric point obtained with the test solution correspond to that of the isoelectric point obtained with the reference solution. |
Peptide mapping | The profile of peptide map shall be in consistency with that of the reference substance. |
N-terminal amino acid sequence | The N-terminal sequence examined by an amino acid sequencer shall be** |
Testing Items | Quality Standard |
Test for bacterial endotoxin | <10 EU/mg |
Sterility test | It shall comply with the test for sterility. |
Testing Items | Quality Control Standard |
Appearance (/Reconstitution time) | White lyophilized powder,The product shall be a clear liquid to reconstitute within 10 minutes. |
Identity test | Immunoblot test or immunodot test shall reveal positive results. |
Test for visible particles | It shall comply with the test for visible particles. |
Protein Content (BCA) | 80%-120% of the labeled amount |
Filling quantity | ≤15% |
pH | ** |
Biological activity (specific activity) | **U/mg |
Purity (RP-HPLC) | ≥96% |
SDS-PAGE | ≥95% |
Molecular Weight | **kDa±**kDa |
Test for Baacterial Endotoxin | <10 EU/mg |
Determination of residual antibiotics | The preparation must not contain any Activity of residual antibiotics. |
Test for abnormal toxicity | It shall comply with the test for abnormal toxicity. |
Test for insoluble particles | It shall comply with the test for Particulate Matter. |
Moisture content | ≤3% |
Sterility test | It shall comply with the test for sterility. |
Determination of Osmolality | **mOsmol/kg |
Isoelectric point | The isoelectric point of ** shall be pH**. The profile of the isoelectric point obtained with the test solution correspond to that of the isoelectric point obtained with the reference solution. |
Peptide mapping | The profile of peptide map shall be in consistency with that of the reference substance. |
Testing Items | Stock Solution Structure Confirmation Test Items |
Determination of Molecular Weight | Theoretically, it shall be **Da |
N-terminal amino acid sequence | The N-terminal sequence examined by an amino acid sequencer shall be** |
C-terminal amino acid sequence | The C-terminal sequence examined by an amino acid sequencer shall be** |
Amino acid composition analysis | The profile of Amino acid composition shall be in consistency with that of the theoretical values. |
Quantitative analysis of disulfide bond positioning | Presence of **disulfide bonds that match the theoretical way, C**-C** |
Isoelectric Point | The isoelectric point of ** shall be pH**. The profile of the isoelectric point obtained with the test solution correspond to that of the isoelectric point obtained with the reference solution. |
Circular Dichroism to identify far/near UV | The profile of Circular Dichroism to identify far/near UV shall be in consistency with that of the reference substance. |
Determination of Sequence Coverage | The profile of Sequence Coverage shall be in consistency with that of the theoretical values. |
Peptide mapping | The profile of peptide map shall be in consistency with that of the reference substance. |
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