Glucosamine Hydrochloride PVP granule DC95

Category:Intermediates > Chiral Intermediates
Product Name:Glucosamine Hydrochloride PVP granule DC95
CAS No.:/
Standard:In-house Standards
Price(USD):0.00
Company:ZHEJIANG AOXING BIOTECHNOLOGY CO., LTD.

Basic Info
  • Grade: Pharmaceutical Grade

    Factory Location: Taizhou Zhejiang

    Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Asia

  • Sample Provided: no

    Zhejiang Aoxing Biotechnology Co., Ltd. - Glucosamine Hydrochloride PVP granule DC95

    Glucosamine Hydrochloride PVP granule DC95

    ITEM

    SPECIFICATION

    TEST METHOD

    Properties (physical):

     

     

    Appearance

    White, Free Granules

    USP29 -- <695>

    Odour

    Odourless

    Complies

    Bulk Density

    NLT0.50g/ml

    USP29 -- <616>

    As Tapped Density

    Meets the requirements of USP29

    USP29 -- <616>

    Particle Size

    100% through 10 mesh, 95% through
    20 mesh

    USP29 -- <811>

    Analytical Properties:

     

     

    Assay (HPLC)

    NLT 95%

    USP29 -- P2100(A)--<621>

    Identification

     

     

    A: Infrared Absorption

    Meets the requirement

    A: USP29 -- P2100--<197K>

    B: Tests for Chloride

    Meets the requirement

    B: USP29 -- <191>

    C: Retention time in the Assay

    Corresponds to the reference standard

    C: USP29 -- P2100--<621>

    Transm

    >90.0% (10.0%Water Solut.-450nm)

    USP29 -- <197>

    Absorb

    <0.25a.u. (10.0% Water Solut.-280nm)

    USP29 -- <197>

    Specific Rotation〔α〕D20

    +67.00°-- +71.00°

    USP29 -- <781S>

    PH (20mg/ml.aq.sol.)

    3.5—5.0

    USP29 -- <791>

    Loss on Drying

    NMT2.0%

    USP29 -- <731>

    Residue on Ignition

    NMT 0.1%

    USP29 -- <281>

    Chloride (Cl)

    16.2% -- 16.7%

    USP29 -- <221>

    Sulfate

    NMT 0.24%

    USP29 -- <221>

    Heavy Metals

    NMT 10 ppm

    USP29 -- <231>Ⅱ

    Iron (fe)

    NMT 10 ppm

    USP29 -- <241>

    Lead

    NMT 0.5 ppm

    AFS

    Arsenic (As)

    NMT 3.0 ppm

    USP29 -- <211>Ⅱ

    Mercury

    NMT 0.5 ppm

    AFS

    Organic volatile impurities

    Meets the Requirements

    USP29 -- <467>Ⅰ

    Microbial:

     

     

    Total Aerobic

    NMT 1,000 cfu/g

    USP29 -- <61>

    Yeast & Mold

    NMT 100 cfu/g

    USP29 -- <61>

    E. Coli

    Negative in 1g

    USP29 -- <61>

    Salmonella

    Negative in 1g

    USP29 -- <61>

    Staphylococcus Aureus

    Negative in 10g

    USP29 -- <61>

    Enterobacteria & other gram neg

    NMT 100 cfu/g

    USP29 -- <61>

    Conclusion:

    Meets USP 29 standards

    Packaging and Storage:

    Store in tight, light-resistant containers under 25℃

    Reason for Change:

    Updating Specification Format to USP 29

    Effective Date:

    Code & Version: DGHCLG95/1

    Part No.:

    DG HCL 03

    Prepared by:

     

    Approved by QC Dept.Manager:

     

     

     
     
     
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