Refined Glucosamine Hydrochloride

ITEM

SPECIFICATION

TEST METHOD

Properties (physical):

Appearance

White Crystalline, Free Flowing Powder

USP29 -- <695>

Odour

Odourless

Complies

Bulk Density

NLT0.70g/ml

USP29 -- <616>

As Tapped Density

Meets the requirements of USP29

USP29 -- <616>

Particle Size

100% through 30 Mesh

USP29 -- <811>

Analytical Properties:

Assay (HPLC)

98.0—102.0% (on the dried basis)

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

+70.00°-- +73.00°

USP29 -- <781S>

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

3.0—5.0

USP29 -- <791>

Loss on Drying

NMT0.5%

USP29 -- <731>

Residue on Ignition

NMT0.1%

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

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 -- <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: DGHCL30/1

Part No.:

DG HCL 01

Prepared by:

Approved by QC Dept.Manager: