Item

  Specification

  Result

  Method

Organoleptic Data

Appearance

Fine powder

Conform

NLS-QCS-1008

Color

Brown Powder

Conform

GB/T 5492-2008

Odor& Taste

Characteristic

Conform

GB/T 5492-2008

Process Data

Solvent(s) Used

Water and ethyl alcohol

Conform

/

Assay 

10:1

Conform

10:1

Drying Method

Spray drying

Conform

/

Excipient

Maltodextrin 

Conform

/

Physical Characteristics

Particle Size (80 mesh)

98.0%pass 80mesh

Conform

GB/T 5507-2008

Moisture

<5.0%

1.8%

GB/T 14769-1993

Ash Content

<4.0%

1.5%

AOAC 942.05, 18th

Solvent Residue

Eur. Pharm

Conform

NLS-QCS-1007

Heavy Metals

Total Heavy Metals

<10 ppm

Conform

USP <231>, method II

Arsenic

<1.0 ppm

Conform

AOAC 986.15, 18th

Lead

<1.0 ppm

Conform

AOAC 986.15, 18th

Mercury

<0.5 ppm

Conform

AOAC 971.21, 18th

Pesticide Residue

666

<0.2ppm

Conform

GB/T5009.19-1996

DDT

<0.2ppm

Conform

GB/T5009.19-1996

Microbiology

Total Plate Count

<1,000cfu/g

17cfu/g

AOAC 990.12, 18th

Total Yeast & Mold

<100cfu/g

3cfu/g

FDA (BAM) Chapter 18, 8th Ed.

E. Coli

Negative

Negative

AOAC 997.11, 18th

Salmonella

Negative

Negative

FDA (BAM) Chapter 5, 8th Ed.

Conclusion  

Conform with specification

Storage        

Store in sealed containers at cool & dry place.

Protect from light, moisture and pest infestation.

Shelf life       

2 years when properly stored