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Impurity Profile of Recombinant Trypsin , Specific Activity ≥ 3800 USP units/mg pro.

Impurity Profile of Recombinant Trypsin , Specific Activity ≥ 3800 USP units/mg pro.

    • Impurity Profile of Recombinant Trypsin , Specific Activity ≥ 3800 USP units/mg pro.
    • Impurity Profile of Recombinant Trypsin , Specific Activity ≥ 3800 USP units/mg pro.
    • Impurity Profile of Recombinant Trypsin , Specific Activity ≥ 3800 USP units/mg pro.
    • Impurity Profile of Recombinant Trypsin , Specific Activity ≥ 3800 USP units/mg pro.
    • Impurity Profile of Recombinant Trypsin , Specific Activity ≥ 3800 USP units/mg pro.
  • Impurity Profile of Recombinant Trypsin , Specific Activity ≥ 3800 USP units/mg pro.

    Product Details:

    Place of Origin: china
    Brand Name: YaxinBio
    Certification: NSF ISO 9001 2015
    Model Number: CAS: 9002-07-7

    Payment & Shipping Terms:

    Minimum Order Quantity: 100mg
    Price: ¥655
    Packaging Details: 10mg,100mg,1g; ice packaging
    Delivery Time: 4-9days
    Payment Terms: T/T
    Supply Ability: 10g per day
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    Detailed Product Description
    Band: Yaxinbio Source: Recombinant E.coli
    Molecular Weight(SDS-PAGE): 24.0±2.4 KDa Usage: Vaccine Production
    Storage Temperature: 2-8℃

    Impurity Profile of Recombinant Trypsin , Specific Activity ≥ 3800 USP units/mg pro.

     

    Impurity compounds may originate from two different sources:

     

    1) Residuals from the manufacturing process

    Due to recombinant trypsin is produced with recombinannt E.coli, impurities from the manufacturing process are mainly from the strain. Host cell protein and endotoxin are three main possible impurities, the detection methods have been established and detected annual.

    These residuals are not influenced trypsin effect, and the content is very limited.

     

    2) Degradation products

    Trypsin is easily self-degradated during the production process. Specific activity is a critical purity criteria for enzymes. For the recombinant trypsin, the specific activity is determined as NLT 3800 USP/mg pro, which is more higher than CP and USP trypsin standard 2500 USP/mg of extracted trypsin from porcine or bovine pancreas. And NLT 3800 USP/mg is a criteria of recombinant trypsin on USP 39.

     

     

    Impurity Profile of Recombinant Trypsin

     

    Impurities Detection Method Limited Content Comments
    Host cell proteins ELISA ≤ 0.1% Annual Test
    Other protein impurities (media) Specific Activity and SDS-PAGE

    ≥ 3800 USP units/mg pro.

    Single major band

    Batch Test

    Recombinant Trypsin have been validated for use in the manufacture of therapeutics approved for human use. The materials of construction have been in use for several decades.

    For recombinant Trypsin, YaxinBio recommends that users undertake characterization studies under the specific use and process conditions expected.

    Contact Details
    Shanghai Yaxin Biotechnology Co.,Ltd.

    Contact Person: Miss Eland

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