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OEM Factory for Food Grade Raw Material Pancreatin for Digestion with GMP Certificate


  • 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

    High-quality comes 1st; assistance is foremost; business enterprise is cooperation” is our business enterprise philosophy which is constantly observed and pursued by our business for OEM Factory for Food Grade Raw Material Pancreatin for Digestion with GMP Certificate, We play a leading role in furnishing clients with good quality goods great provider and aggressive charges.
    High-quality comes 1st; assistance is foremost; business enterprise is cooperation” is our business enterprise philosophy which is constantly observed and pursued by our business for China Pancreatic Enzyme Pancreatin Powder and Digestive Pancreatic Enzyme Powder, Our products are exported worldwide. Our customers are always satisfied with our reliable quality, customer-oriented services and competitive prices. Our mission is “to continue to earn your loyalty by dedicating our efforts to the constant improvement of our products and services in order to ensure the satisfaction of our end-users, customers, employees, suppliers and the worldwide communities in which we cooperate”.

    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

    High-quality comes 1st; assistance is foremost; business enterprise is cooperation” is our business enterprise philosophy which is constantly observed and pursued by our business for OEM Factory for Food Grade Raw Material Pancreatin for Digestion with GMP Certificate, We play a leading role in furnishing clients with good quality goods great provider and aggressive charges.
    OEM Factory for China Pancreatic Enzyme Pancreatin Powder and Digestive Pancreatic Enzyme Powder, Our products are exported worldwide. Our customers are always satisfied with our reliable quality, customer-oriented services and competitive prices. Our mission is “to continue to earn your loyalty by dedicating our efforts to the constant improvement of our products and services in order to ensure the satisfaction of our end-users, customers, employees, suppliers and the worldwide communities in which we cooperate”.


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