ITEM

SPECIFICATION

TEST METHOD

Properties (physical):

Appearance

White Crystalline, Free Flowing Powder

USP29 -- <695>

Odour

Odourless

Complies

Bulk Density

NLT0.85g/ml

USP29 -- <616>

As Tapped Density

Meets the requirements of USP29

USP29 -- <616>

Particle Size

100% through 80 Mesh

USP29 -- <811>

Analytical Properties:

Assay (HPLC)

98.0—102.0% (on the dried basis)

USP29 -- P2101(A)--<621>

Identification

A: Infrared Absorption

Meets the requirement

A: USP29 --P2101--<197K>

B: Tests for Chloride,Potassium,and Sulfate

Meets the requirement

B: USP29 -- <191>

C: Retention time in the Assay

Corresponds to the reference standard

C: USP29 --P2101--<621>

Transm

>90.0% (10.0%Water Solut.-450nm)

USP29 -- <197>

Specific Rotation〔α〕D20

+50.00°-- +52.00°

USP29 -- <781S>

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

3.0—5.0

USP29 -- <791>

Loss on Drying

NMT1.0%

USP29 -- <731>

Residue on Ignition

27.0%--29.0%

USP29 -- <281>

Chloride (Cl)

11.7% -- 12.3%

USP29 -- <221>

Content of Sulfate

15.5%--16.5%

USP29 – P2101(COS)

Potassium

11.7%--13.0%

USP29 – P2101(P)

Sodium

No Precipitate is Formed

USP29 – P2101(S)

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: DG2KCL-cocrystallised 30/1

Part No.:

DG KCL 04

Prepared by:

Approved by QC Dept. Manager: