Refined N-Acetyl-D-Glucosamine

Name: Refined N-Acetyl-D-Glucosamine
Availability: refined-n-acetyl-d-glucosamine-70057.html

Category:Intermediates > Chiral Intermediates
Product Name:Refined N-Acetyl-D-Glucosamine
CAS No.:/
Standard:In-house Standards
Price(USD):0.00
Company:ZHEJIANG AOXING BIOTECHNOLOGY CO., LTD.

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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. - Refined N-Acetyl-D-Glucosamine

Refined N-Acetyl-D-Glucosamine

ITEM	SPECIFICATION	TEST METHOD
Properties (physical):
Appearance	White Crystalline, Free Flowing Powder	USP29 -- <695>
Bulk Density	NLT0.40g/ml	USP29 -- <616>
As Tapped Density	Meets the requirements of USP29	USP29 -- <616>
Analytical Properties:
Assay (HPLC)	97.5～102.5% (on the dried basis)	USP29 -- <541>
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	+38.9°～+42.9°	USP29 -- <781S>
PH (20mg/ml.aq.sol.)	6.0～7.5	USP29 -- <791>
Loss on Drying	NMT0.5%	USP29 -- <731>
Residue on Ignition	NMT 0.1%	USP29 -- <281>
Chloride (Cl)	NMT0.1%	USP29 -- <221>
Melting Point	200°C～204°C	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 0.5 ppm	USP29 -- <211>Ⅱ
Mercury	NMT 0.5 ppm	AFS
Organic volatile impurities	Meets the Requirements	USP29 -- <467>Ⅰ
Impurities and Related Substances:
5-Hydroxymethyl-2-Furaldehyde	NMT 0.50%	HPLC
Pyrazine	NMT 0.10%	HPLC
2-Furaldehyde	NMT 0.10%	HPLC
Individual Unknown Impurities	NMT 0.10%	HPLC
Total Related Impurities	NMT 2.5%	HPLC
Chloramphenicol	Negative	LC/MS
Nitrofuran & Metabolites	Negative	HPLC
Phenylalanine	Negative	GC
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:Jun.02,2007	Code & Version: N-Acetyl-G100/1
Part No.:	NA DG 02
Prepared by:
Approved by QC Dept. Manager:

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