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OEM China China Medical Graderaw Material Pancreatin for Digestion with ISO Certificate (CAS 8049-47-6)


  • CAS Number: 8049-47-6
  • HS CODE: 3507.9090.90
  • File Service: Chinese-GMP/EU-GMP/DMF/EU-DMF
  • Pharmacopoeia standard: EP/USP/CP
  • Product Detail

    Product Tags

    owing to excellent assistance, a variety of high quality products and solutions, aggressive costs and efficient delivery, we take pleasure in an excellent popularity amongst our customers. We are an energetic business with wide market for OEM China China Medical Graderaw Material Pancreatin for Digestion with ISO Certificate (CAS 8049-47-6), Any necessitates from you will be compensated with our greatest consideration!
    owing to excellent assistance, a variety of high quality products and solutions, aggressive costs and efficient delivery, we take pleasure in an excellent popularity amongst our customers. We are an energetic business with wide market for China Pancreatic Enzyme Pancreatin Powder, Digestive Pancreatic Enzyme Powder, With its rich manufacturing experience, high-quality products and solutions, and perfect after-sale service, the company has gained good reputation and has become one of the famous enterprise specialized in manufacturing series.We sincerely hope to establish business relation with you and pursue mutual benefit.

    Detail

    1. Characters: Pancreatin is a slightly brown, amorphous powder or slightly brown to cream-coloured granule. It is composed of amylase, lipase and protease.

    2. Extraction Source: Porcine pancreas.

    3. process: Pancreatin is extracted from healthy porcine pancreas by our exclusive activation-extraction technology.

    4 .Indications and uses: Pancreatin is a mixture of several digestive enzymes produced by the pancreas of porcine. It can be used in the pharmaceutical industry, food processing, tanning, washing and other fields, with a wide range of applications.

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    Why us?

    ·Produced in GMP workshop

    ·27 years of biological enzyme R&D history

    ·Raw materials are traceable

    ·Comply with customer standard

    ·Export to over 30 countries and regions

    ·Has the ability of quality system management such as US FDA, Japan PMDA, South Korea MFDS, etc.

    Specification

    Test Items

    Company Specification

    CP

    EP

    USP

    Characters

    Powder

    A slightly brown, amorphous powder

    A slightly brown, amorphous powder

    A slightly brown, amorphous powder

    Granule

    A slightly brown to cream-coloured granule

    A slightly brown to cream-coloured granule

    A slightly brown to cream-coloured granule

    Identification

    ————

    Conforms

    ————

    Tests

    Fat content

    ≤20mg/g

    ≤ 5.0%

    ≤3.0%(<3USP);≤ 6.0%(≥3USP)

    Loss on drying

    ≤5.0% 105℃, 4h

    ≤ 5.0% 670Pa 60℃, 4h

    ≤ 5.0%Dry in Vacuum 60℃, 4h

    Residual solvent

    ————

    ≤ 0.5%According to EP(5.4)

    ≤ 0.5%According to USP(467)

    Particle size

    ————

    According to EP(2.1.4&2.9.12)

    According to USP(811)

    Assay

    Protease

    ≥600U/g

    1.0~5.2Ph.Eur.U/mg

    100~450USP.U/mg

    Amylase

    ≥7000U/g

    12.0~80.0Ph.Eur.U/mg

    100~500USP.U/mg

    Lipase

    ≥4000U/g

    15.0~130Ph.Eur.U/mg

    10~90USP.U/mg

    Microbial Impurities

    TAMC

    ≤ 10000cfu/g

    ≤ 10000cfu/g

    ≤ 10000cfu/g

    TYMC

    ≤ 100cfu/g

    ≤ 100cfu/g

    ≤ 100cfu/g

    E.coli

    Conforms

    Conforms

    Conforms

    Salmonella

    Conforms

    Conforms

    Conforms

    owing to excellent assistance, a variety of high quality products and solutions, aggressive costs and efficient delivery, we take pleasure in an excellent popularity amongst our customers. We are an energetic business with wide market for OEM China China Medical Graderaw Material Pancreatin for Digestion with ISO Certificate (CAS 8049-47-6), Any necessitates from you will be compensated with our greatest consideration!
    OEM China China Pancreatic Enzyme Pancreatin Powder, Digestive Pancreatic Enzyme Powder, With its rich manufacturing experience, high-quality products and solutions, and perfect after-sale service, the company has gained good reputation and has become one of the famous enterprise specialized in manufacturing series.We sincerely hope to establish business relation with you and pursue mutual benefit.


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