Tests

Limits

Appearance

White crystalline , free flowing powder

Bulk Density

NLT 0.45g/ml

As Tapped Density

Meets the requirements of USP32

Particle Size

100% through 100mesh

Assay(HPLC)

98.0 ~102.0% (on the dried basis)

Specific Rotation

+39.0°~ +43.0°

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

6.0~8.0

Loss on drying

NMT0.5%

Residue on ignition

NMT0.1%

Chloride(Cl)

NMT0.2%

Melting point

196°C~205°C

Heavy metals

NMT10ppm

Iron(Fe)

NMT10ppm

Lead

NMT0.5ppm

Arsenic(As)

NMT0.5ppm

Mercury

NMT0.5ppm

Organic volatile impurities

Meets the requirements

Total Aerobic

NMT 1000cfu/g

Yeast & Mold

NMT 100cfu/g

E.Coli

Negative in 1g

Salmonella

Negative in 1g

Staphylococcus Aureus

Negative in 10g

Enterobacteria & other gram neg

NMT 100cfu/g