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Refinação de Cloridrato de Glucosamina

Informação básica

Modelo:  EHP-1001

Descrição do produto

Especificação: 98.0% -102.0% Código HS: 2938909090 Pó: Sim Certificação: GMP, ISO 9001 Estado: Sólido Marca registrada: sino- Excelente Origem: China
ITEM SPECIFICATION TEST METHOD
Properties (physical):    
Appearance White Crystalline, Free Flowing Powder USP29 --
Odour Odourless Complies
Bulk Density NLT0.70g/ml USP29 --
As Tapped Density Meets the requirements of USP29 USP29 --
Particle Size 100% through 30 Mesh USP29 --
Analytical Properties:    
Assay (HPLC) 98.0-102.0% (on the dried basis) USP29 -- P2100(A)--
Identification    
A: Infrared Absorption Meets the requirement A: USP29 -- P2100--
B: Tests for Chloride Meets the requirement B: USP29 --
C: Retention time in the Assay Corresponds to the reference standard C: USP29 -- P2100--
Transm >90.0% (10.0%Water Solut.-450nm) USP29 --
Absorb <0.25a.u. (10.0% Water Solut.-280nm) USP29 --
Specific Rotation(α)D20 +70.00°-- +73.00° USP29 --
PH (20mg/ml.aq.sol.) 3.0-5.0 USP29 --
Loss on Drying NMT0.5% USP29 --
Residue on Ignition NMT0.1% USP29 --
Chloride (Cl) 16.2% --16.7% USP29 --
Sulfate NMT 0.24% USP29 --
Heavy Metals NMT 10 ppm USP29 --II
Iron (fe) NMT 10 ppm USP29 --
Lead NMT 0.5 ppm AFS
Arsenic (As) NMT 3.0 ppm USP29 --II
Mercury NMT 0.5 ppm AFS
Organic volatile impurities Meets the Requirements USP29 --I
Impurities and Related Substances:    
N-Acetyl Glucosamine NMT 2.0% HPLC
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 --
Yeast & Mold NMT 100 cfu/g USP29 --
E. Coli Negative in 1g USP29 --
Salmonella Negative in 1g USP29 --
Staphylococcus Aureus Negative in 10g USP29 --
Enterobacteria & other gram neg NMT 100 cfu/g USP29 --
Conclusion: Meets USP 29 standards
Packaging and Storage: Store in tight, light-resistant containers under 25 ºC
Reason for Change: Updating Specification Format to USP 29
Effective Date: Code & Version: DGHCL30/1
Part No.: DG HCL 01
Prepared by:  
Approved by QC Dept.Manager:  

Grupo de Produto : Intermediários Farmacêuticos

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