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Factory wholesale Medical Graderaw 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

    So as to give you ease and enlarge our company, we also have inspectors in QC Team and assure you our greatest support and product or service for Factory wholesale Medical Graderaw Material Pancreatin for Digestion with GMP Certificate, For those who pursuit the Hi-quality, Hi-stable, Aggressive price components, organization name is your greatest choice!
    So as to give you ease and enlarge our company, we also have inspectors in QC Team and assure you our greatest support and product or service for China Pancreatic Enzyme Pancreatin Powder and Digestive Pancreatic Enzyme Powder, We adhere to client 1st, top quality 1st, continuous improvement, mutual advantage and win-win principles. When cooperation together with the customer, we provide shoppers with the highest high-quality of service. Established good business relations using the Zimbabwe buyer inside the business, we’ve got established own brand and reputation. At the identical time, wholeheartedly welcome new and old prospects to our company to go to and negotiate small business.

    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

    So as to give you ease and enlarge our company, we also have inspectors in QC Team and assure you our greatest support and product or service for Factory wholesale Medical Graderaw Material Pancreatin for Digestion with GMP Certificate, For those who pursuit the Hi-quality, Hi-stable, Aggressive price components, organization name is your greatest choice!
    Factory wholesale China Pancreatic Enzyme Pancreatin Powder and Digestive Pancreatic Enzyme Powder, We adhere to client 1st, top quality 1st, continuous improvement, mutual advantage and win-win principles. When cooperation together with the customer, we provide shoppers with the highest high-quality of service. Established good business relations using the Zimbabwe buyer inside the business, we’ve got established own brand and reputation. At the identical time, wholeheartedly welcome new and old prospects to our company to go to and negotiate small business.


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