Description:

Color 

white powder

Complies

Flavor & Odor

Characteristic

Complies

Identification

IR or UV

Complies

Physical:

Loss on drying (3h at 105°C)

≤1.0%

     0.35%

Specific optical rotation

+45°~ +51°

     +47.8°

Chemical:

Heavy metals

<10ppm

Complies

Lead

<5ppm

Complies

Arsenic

<2ppm

Complies

Single impurity

≤1.0%

0.20%

Total impurity

≤1.5%

0.42%

Assay:

Progesterone

97.0%~103.0%

      99.20%    

Microbial

Total microbacterial Count

Max. 1,000/g

Complies

Yeast & Mould

Max. 100/g

Complies

Escherichia coli presence

Negative

Complies

Salmonella

Negative

Complies

Conclusion

Conform to USP 32 Standard