ITEM

SPECIFICATION

TEST METHOD

Properties (physical):

Appearance

White Crystalline, Free Flowing Powder

USP29 -- <695>

Odour

Odourless

Complies

Bulk Density

NLT0.65g/ml

USP29 -- <616>

As Tapped Density

Meets the requirements of USP29

USP29 -- <616>

Particle Size

NLT90% through 80 Mesh

USP29 -- <811>

Analytical Properties:

Assay (HPLC)

98.0102.0% (on the dried basis)

USP29 -- P2102(A) -- <621>

Identification

A: Infrared Absorption

Meets the requirement

A: USP29 -- P2102--<197K>

B: Tests for Chloride,Sodium,and Sulfate

Meets the requirement

B: USP29 -- <191>

C: Retention time in the Assay

Corresponds to the reference standard

C: USP29 -- P2102-- <621>

Transm

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

USP29 -- <197>

Specific RotationαD20

+52.00°-- +54.00°

USP29 -- <781S>

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

3.05.0

USP29 -- <791>

Loss on Drying

NMT1.0%

USP29 -- <731>

Residue on Ignition

23.5%--25.0%

USP29 -- <281>

Chloride (Cl)

11.7% -- 12.5%

USP29 -- <221>

Content of Sulfate

16.3%--17.3%

USP29 P2102(COS)

Sodium

7.0%--8.3%

USP29 P2102(S)

Potassium

No Precipitate is Formed

USP29 P2102(P)

Heavy Metals

NMT 10 ppm

USP29 -- <231>

Iron (fe)

NMT 10 ppm

USP29 -- <241>

Lead

NMT 0.5 ppm

AFS

Arsenic (As)

NMT 3.0 ppm

USP29 -- <211>

Mercury

NMT 0.5 ppm

AFS

Organic volatile impurities

Meets the Requirements

USP29 -- <467>

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: DG2NaCL-cocrystallised 80/1

Part No.:

DG NaCL 04

Prepared by:

Approved by QC Dept. Manager: