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: