ITEM

SPECIFICATION

TEST METHOD

Properties (physical):

Appearance

Off white to creamy powder (Visual)

USP29 -- <695>

Bulk Density

NLT0.55g/ml

USP29 -- <616>

As Tapped Density

Meets the requirements of USP29

USP29 -- <616>

Analytical Properties:

Assay (HPLC)

More than 90%

HPLC

Identification

A: Infrared Absorption

Meets the requirement

A: USP29 -- <197K>

B: Tests for Sodium

Meets the requirement

B: USP29 -- <191>

Absorb

<0.35a.u. (5.0% Water Solut.-420nm)

USP29 -- <197>

Specific Rotation[α]D20

minus20.0°-- minus30.0°

USP29 -- <781S>

PH (1%H2O solution.)

5.5-7.5

USP29 -- <791>

Loss on Drying

NMT10%

USP29 -- <731>

Residue on Ignition

NMT20%-30% (dry base)

USP29 -- <281>

Chloride (Cl)

NMT 0.5%

USP29 -- <221>

Sulfate

NMT 0.24%

USP29 -- <221>

protein

NMT 6.0%

USP29

Heavy Metals

NMT 20 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

Microbial:

Total Bacteria Count

NMT 1,000 cfu/g

USP29 -- <61>

Yeast & Mold

NMT 100 cfu/g

USP29 -- <61>

E. Coli

Negative

USP29 -- <61>

Salmonella

Negative

USP29 -- <61>

Staphylococcus Aureus

Negative

USP29 -- <61>

Conclusion:

Meets USP 29 standards

Packaging and Storage:

Store in tight, containers under 25℃

Reason for Change:

Updating Specification Format to USP 29

Effective Date:

Code & Version: CSB/1

Part No.:

CSB 01

Prepared by:

Approved by QC Dept.Manager: