Service Case New Drug Development Case
New drug development commission case
Service Case New Drug Development Case
Stock Solution:
Testing ItemsQuality Standard
Protein Content (BCA)≥ ** mg/ml
Biological activity (specific activity)**U/mg
Purity (RP-HPLC)≥96%
Purity (SDS-PAGE)≥95%
Molecular WeightkDa± kDa
Endotoxin<10 EU/mg
pH**
Ultraviolet spectroscopyThe maximum absorption peak shall be at 278nm±3nm scanning.
Content of residual extraneous DNAContent of residual extraneous DNA shall be not more than 10ng/dose
Content of Residual antibioticsThe preparation must not contain any Activity of residual antibiotics.
Content of residual Heavy Metal NiContent of residual Heavy Metal Ni  shall be not more than 2μg/ml.
Content of residual host bacteria proteinsContent of residual host bacteria proteins shall be not more than 0.10% of total proteins.
Content of residual Sumo EnzymeThe preparation must not contain any Activity of residual Sumo Enzyme.
Isoelectric pointThe 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 mappingThe profile of  peptide map shall be in consistency with that of the reference substance.
N-terminal amino acid sequenceThe N-terminal sequence examined by an amino acid sequencer shall be**
Final bulk:
Testing ItemsQuality Standard
Test for bacterial endotoxin<10 EU/mg
Sterility testIt shall comply with the test for sterility.
Final product:
Testing ItemsQuality Control Standard
Appearance (/Reconstitution time)White lyophilized powder,The product shall be a clear liquid to reconstitute within 10 minutes.
Identity testImmunoblot test or immunodot test shall reveal positive results.
Test for visible particlesIt 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 antibioticsThe preparation must not contain any  Activity of residual antibiotics.
Test for abnormal toxicityIt shall  comply with the test for abnormal toxicity.
Test for insoluble particlesIt shall comply with the test for Particulate Matter.
Moisture content≤3%
Sterility testIt shall comply with the test for sterility.
Determination of Osmolality**mOsmol/kg
Isoelectric pointThe 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 mappingThe profile of  peptide map shall be in consistency with that of the reference substance.
Testing ItemsStock Solution Structure Confirmation Test Items
Determination of Molecular WeightTheoretically, it shall be **Da
N-terminal amino acid sequenceThe N-terminal sequence examined by an amino acid sequencer shall be**
C-terminal amino acid sequenceThe C-terminal sequence examined by an amino acid sequencer shall be**
Amino acid composition analysisThe profile of  Amino acid composition shall be in consistency with that of the theoretical values.
Quantitative analysis of disulfide bond positioningPresence of **disulfide bonds that match the theoretical way, C**-C**
Isoelectric PointThe 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 UVThe profile of  Circular Dichroism to identify far/near UV shall be in consistency with that of the reference substance.
Determination of Sequence CoverageThe profile of  Sequence Coverage shall be in consistency with that of the theoretical values.
Peptide mappingThe profile of  peptide map shall be in consistency with that of the reference substance.
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