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OEM/ODM China Medical Graderaw Material Pancreatic Enzyme Pancreatin Powder for Digestion with BRC 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

    “Control the standard by the details, show the toughness by quality”. Our firm has strived to establish a highly efficient and stable workers workforce and explored an effective high-quality management system for OEM/ODM China Medical Graderaw Material Pancreatic Enzyme Pancreatin Powder for Digestion with BRC Certificate, Leading the trend of this field is our persistent objective. Supplying first class solutions is our intention. To create a beautiful upcoming, we wish to cooperate with all close friends in the home and overseas. Should you have got any interest in our products and solutions, remember to never wait to call us.
    “Control the standard by the details, show the toughness by quality”. Our firm has strived to establish a highly efficient and stable workers workforce and explored an effective high-quality management system for China Pancreatic Enzyme Pancreatin Powder and Digestive Pancreatic Enzyme Powder, We can give our clients absolute advantages in product quality and cost control, and we have full range of molds from up to one hundred of factories. As product updating fast, we succeed in developing many high quality products for our clients and get high reputation.

    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

    “Control the standard by the details, show the toughness by quality”. Our firm has strived to establish a highly efficient and stable workers workforce and explored an effective high-quality management system for OEM/ODM China Medical Graderaw Material Pancreatic Enzyme Pancreatin Powder for Digestion with BRC Certificate, Leading the trend of this field is our persistent objective. Supplying first class solutions is our intention. To create a beautiful upcoming, we wish to cooperate with all close friends in the home and overseas. Should you have got any interest in our products and solutions, remember to never wait to call us.
    OEM/ODM China China Pancreatic Enzyme Pancreatin Powder and Digestive Pancreatic Enzyme Powder, We can give our clients absolute advantages in product quality and cost control, and we have full range of molds from up to one hundred of factories. As product updating fast, we succeed in developing many high quality products for our clients and get high reputation.


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