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Factory Directly supply China Purity Raw Material Pancreatin/Pancreatic Enzyme/Active Pharma Ingredients


  • 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

    Our focus on should be to consolidate and enhance the quality and repair of present products, in the meantime constantly establish new products to meet unique customers’ requires for Factory Directly supply China Purity Raw Material Pancreatin/Pancreatic Enzyme/Active Pharma Ingredients, Our Lab now is “National Lab of diesel engine turbo technology ” , and we own a qualified R&D staff and complete testing facility.
    Our focus on should be to consolidate and enhance the quality and repair of present products, in the meantime constantly establish new products to meet unique customers’ requires for China Pancreatin, Pancreatic Enzyme, All our goods are exported to clients in the UK, Germany, France, Spain, the USA, Canada, Iran, Iraq, the Middle East and Africa. Our products and solutions are well welcomed by our customers for the high quality, competitive prices and the most favorable styles. We hope to establish business relationship with all customers and bring more beautifu colors for the life.

    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

    We Directly supply China Pancreatin, Pancreatic Enzyme, All our goods are exported to clients in the UK, Germany, France, Spain, the USA, Canada, Iran, Iraq, the Middle East and Africa. Our products and solutions are well welcomed by our customers for the high quality, competitive prices and the most favorable styles. We hope to establish business relationship with all customers and bring more beautifu colors for the life.


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