ITEM

SPECIFICATION

TEST METHOD

Properties (physical):

Appearance

White, Free Granules

USP29 -- <695>

Odour

Odourless

Complies

Bulk Density

NLT0.50g/ml

USP29 -- <616>

As Tapped Density

Meets the requirements of USP29

USP29 -- <616>

Particle Size

100% through 10 mesh, 95% through
20 mesh

USP29 -- <811>

Analytical Properties:

Assay (HPLC)

NLT 95%

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

+67.00°-- +71.00°

USP29 -- <781S>

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

3.5—5.0

USP29 -- <791>

Loss on Drying

NMT2.0%

USP29 -- <731>

Residue on Ignition

NMT 0.1%

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

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: DGHCLG95/1

Part No.:

DG HCL 04

Prepared by:

Approved by QC Dept.Manager: