Zhejiang Aoxing Biotechnology Co., Ltd. - Refined N-Acetyl-D-Glucosamine
Refined N-Acetyl-D-Glucosamine
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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 Crystalline, Free Flowing Powder
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USP29 -- <695>
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Bulk Density
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NLT0.40g/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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Analytical Properties:
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Assay (HPLC)
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97.5~102.5% (on the dried basis)
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USP29 -- <541>
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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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+38.9°~+42.9°
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USP29 -- <781S>
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PH (20mg/ml.aq.sol.)
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6.0~7.5
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USP29 -- <791>
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Loss on Drying
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NMT0.5%
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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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NMT0.1%
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USP29 -- <221>
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Melting Point
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200°C~204°C
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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 0.5 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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Impurities and Related Substances:
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5-Hydroxymethyl-2-Furaldehyde
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NMT 0.50%
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HPLC
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Pyrazine
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NMT 0.10%
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HPLC
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2-Furaldehyde
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NMT 0.10%
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HPLC
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Individual Unknown Impurities
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NMT 0.10%
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HPLC
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Total Related Impurities
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NMT 2.5%
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HPLC
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Chloramphenicol
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Negative
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LC/MS
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Nitrofuran & Metabolites
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Negative
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HPLC
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Phenylalanine
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Negative
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GC
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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:Jun.02,2007
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Code & Version: N-Acetyl-G100/1
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Part No.:
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NA DG 02
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Prepared by:
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Approved by QC Dept. Manager:
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