Zhejiang Aoxing Biotechnology Co., Ltd. - Glucosamine Hydrochloride HPMC granule DC95
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Glucosamine Hydrochloride HPMC granule DC95
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ITEM
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SPECIFICATION
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TEST METHOD
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Properties (physical):
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Appearance
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White, Free Granules
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USP29 -- <695>
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Odour
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Odourless
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Complies
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Bulk Density
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NLT0.50g/ml
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USP29 -- <616>
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As Tapped Density
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Meets the requirements of USP29
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USP29 -- <616>
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Particle Size
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100% through 10 mesh, 95% through
20 mesh
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USP29 -- <811>
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Analytical Properties:
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Assay (HPLC)
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NLT 95%
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USP29 -- P2100(A)--<621>
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Identification:
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A: Infrared Absorption
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Meets the requirement
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A: USP29 -- P2100--<197K>
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B: Tests for Chloride
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Meets the requirement
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B: USP29 -- <191>
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C: Retention time in the Assay
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Corresponds to the reference standard
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C: USP29 -- P2100--<621>
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Transm
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>90.0% (10.0%Water Solut.-450nm)
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USP29 -- <197>
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Absorb
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<0.25a.u. (10.0% Water Solut.-280nm)
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USP29 -- <197>
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Specific Rotation〔α〕D20
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+67.00°-- +71.00°
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USP29 -- <781S>
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pH (20mg/ml.aq.sol.)
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3.5—5.0
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USP29 -- <791>
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Loss on Drying
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NMT2.0%
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USP29 -- <731>
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Residue on Ignition
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NMT 0.1%
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USP29 -- <281>
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Chloride (Cl)
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16.2% --16.7%
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USP29 -- <221>
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Sulfate
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NMT 0.24%
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USP29 -- <221>
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Heavy Metals
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NMT 10 ppm
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USP29 -- <231>Ⅱ
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Iron (fe)
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NMT 10 ppm
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USP29 -- <241>
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Lead
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NMT 0.5 ppm
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AFS
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Arsenic (As)
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NMT 3.0 ppm
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USP29 -- <211>Ⅱ
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Mercury
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NMT 0.5 ppm
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AFS
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Organic volatile impurities
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Meets the Requirements
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USP29 -- <467>Ⅰ
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Microbial:
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Total Aerobic
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NMT 1,000 cfu/g
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USP29 -- <61>
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Yeast & Mold
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NMT 100 cfu/g
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USP29 -- <61>
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E. Coli
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Negative in 1g
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USP29 -- <61>
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Salmonella
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Negative in 1g
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USP29 -- <61>
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Staphylococcus Aureus
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Negative in 10g
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USP29 -- <61>
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Enterobacteria & other gram neg
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NMT 100 cfu/g
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USP29 -- <61>
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Conclusion:
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Meets USP 29 standards
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Packaging and Storage:
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Store in tight, light-resistant containers under 25℃
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Reason for Change:
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Updating Specification Format to USP 29
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Effective Date:
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Code & Version: DGHCLG95/1
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Part No.:
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DG HCL 04
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Prepared by:
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Approved by QC Dept.Manager:
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