Test Items

USP 40 Standard specifications

Properties (physical):

Appearance

White Crystalline, Free Flowing Powder

Odour

Odourless

Bulk Density

NLT0.60g/ml

As Tapped Density

Meets the requirements of USP32

Particle Size

NLT 90% through 40 Mesh

Analytical Properties:

Assay (HPLC)

98.0—102.0% (on the dried basis)

Identification

A: Infrared Absorption

Meets the requirement

B: Tests for Chloride

Meets the requirement

C: Retention time in the Assay

Corresponds to the reference standard

Transm

＞90.0% (10.0%Water Solut.-450nm)

Absorb

＜0.25a.u. (10.0% Water Solut.-280nm)

Specific Rotation〔α〕D20

+70.00°-- +73.00°

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

3.0—5.0

Loss on Drying

NMT0.5%

Residue on Ignition

NMT 0.1%

Chloride (Cl)

16.2% -- 16.7%

Sulfate

NMT 0.24%

Heavy Metals

NMT 10 ppm

Iron (fe)

NMT 10 ppm

Lead

NMT 0.5 ppm

Arsenic (As)

NMT 3.0 ppm

Mercury

NMT 0.5 ppm

Organic volatile impurities

Meets the Requirements

Microbial:

Total Aerobic

NMT 1,000 cfu/g

Yeast and Mold

NMT 100 cfu/g

E. Coli

Negative in 1g

Salmonella

Negative in 1g

Staphylococcus Aureus

Negative in 10g

Enterobacteria & other gram neg

NMT 100 cfu/g