白桦脂醇

Product Name

Betulin

Country of Origin

China

Botanical Source

Betula Platyphylla

Part Used

Bark (100% Natural)

Batch No.

BHZC-200620

Batch Quantity

100KGS

Manufacturing Date

Jun 20, 2020

Expiry Date

Jun 19, 2023

Sterilization Method

Heat || NON-IRR

Kosher || Halal

Yes

Items

Specification

Result

Method

Content

Betulin≥98%

99.1%

HPLC || USP

Identification

Positive

Positive

FT-IR

Physical Characteristics

Appearance

White to off-white

Fine free-flowing powder

Conform

Visual

Odor& Taste

Characteristic

Characteristic

Organoleptic

Loss on Drying

≤2.0%

0.81%

USP <731>

Residue on ignition

≤0.5%

0.27%

USP <561>

Bulk Density

 40~60 g/100ml

47.8g/100ml

USP <616> Method I

Particle Size

100% Through 80 mesh

100%

Analytical sieving || USP <786>

Chemical Characteristics

Heavy Metals (as Pb)

≤ 10ppm

<10ppm

USP <231> Method II

Arsenic (As)

≤ 1ppm

<1ppm

ICP-MS

Lead (Pb)

≤ 1ppm

<1ppm

ICP-MS

Cadmium (Cd)

≤0.05ppm

<0.05ppm

ICP-MS

**(Hg)

≤0.2ppm

<0.2ppm

ICP-MS

Microbiological Characteristics

Total Plate Count

NMT1000cfu/g

Conform

USP<61>

Yeast & Mold

NMT300cfu/g

Conform

USP<61>

E.Coli

Not Detected in(g) 10

Not Detected

USP<61>

Salmonella

Not Detected in(g) 25

Not Detected

USP<61>

Packing and Storage

25kg net. Polyethylene bag with cardboard drum; Store in tight, light-resistant containers;

Avoid exposure to direct sunlight, moisture, and excessive heat.

Conclusion

The product conforms with above Specifications.