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Wuhan uni-pharma bio-tech co.,ltd
Wuhan Uni-pharma Bio-tech Co.,Ltd
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Recombinant Human Insulin Recombinant Insulin Glargine Diabetes Mellitus

Recombinant Human Insulin Recombinant Insulin Glargine Diabetes Mellitus

Brand Name : UNIPHAR
Model Number : API
Certification : GMP
Place of Origin : CHINA
MOQ : 20 tons
Price : Negotiation
Supply Ability : 50 tons per month
Delivery Time : 45-50 days
Packaging Details : Laminated films and pouches(PET/AL/PE) for pharmaceutical packaging
Molecular formula : C257 H383 N65 O77 S6
Formula weight : 5807.69
Specific rotation : -64°±8°(C=2,0.003mol/L NaOH)
Melting point : 233℃
Character : White or white crystalline powder
Efficcy : Diabetes mellitus
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Test itemsAcceptance CriteriaTest ResultEvaluation
CharacteristicsWhite or almost white crystalline powderWhite crystalline powdercomplied
Identification (HPLC)The retention time of the principal peak of the test solution in the chromatogram obtained in the Assay is identical with that of principal peak in the chromatogram of the reference solution.compliedcomplied
Identificaiton(HPLC)The peptide map of the test solution corresponds to that of the reference solution.compliedcomplied
Related substances

A21 is not greater than 0.5%

Other impurities are not greater than 1.8%

A21: 0.08%

Other impurities: 0.36%

complied
High molecular weight proteinsNot greater than 0.5%0.08%complied
Loss on dryingLoses not more than 10.0% of its weight4.49%complied
Residue on ignitionNot more than 2.0%, calculated on the dried basis.1.3%complied
ZincNot more than 1.0%, calculated on the dried basis.0.42%complied
Microbial LimitThe total bacterial count does not exceed 300cfu per g of recombinant human insulin.<10cfu/gcomplied
Bacterial endotoxinsLess than 5 EU per mg of recombinant human insulin.<0.625EU/mgcomplied
Host-cell-and vector-derived DNANot more than 5 ng per dose (equivalent to 1.5mg recombinant human insulin).<5ng/dosecomplied
Host -cell-derived proteinNot more than 10ng per mg of recombinant human insulin<1.5ng/mgcomplied
KanamycinNot more than 0.5ng per mg of recombinant human insulin<0.2ng/mgcomplied
Assay95.0%~105.0% of human insulin including insulin A21 desamido insulin , calculated on the basis99.2%complied
BioactivityNot less than 15 Units per mg20IU/mgcomplied
Solvent

Ethanol: Not more than 0.5%.

Isopropanol: Not more than 0.5%.

Cholamine: Not detectable (Less than 1ppm)

n.a.n.a.

N-terminal Amino acid sequence


N-terminal Amino acid sequence of chain A and Chain B are identical with theoretical sequencen.a.n.a.

Conclusion : Qualified

Remark: Select one batch produce of recombinant human insulin to test solvent and N-terminal Amino acid sequence every year.


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active pharmaceutical intermediates

      

pharmaceutical raw materials

      
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