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EZ891331a Lipo-Max™ Liposomal Berberine Hydrochloride 50%
    Publish time 2026-01-14 11:21    
EZ891331a Lipo-Max™ Liposomal Berberine Hydrochloride 50%

Certificate of Analysis

Product Name: Lipo-Max™ Liposomal   Berberine Hydrochloride 50%

CAS No.: 633-65-8

Molecular Formula: C20H18NO4.Cl

Country of Origin: China

Molecular Weight: 371.81

 Batch Size: 100KG

 Batch No.: S20250308

Production Date: March 8, 2025

Expiry   Date: May 7, 2027

 

Test   Item

Specification

Result

Test   Method

Assay   of Berberine Hydrochloride

≥50%  

52.8%

HPLC

Appearance

Yellow   powder

Conforms

Visual

Odor                            

Natural   smell and Characteristic

Conforms

Organoleptic

Mesh   Size

100%   pass 80 mesh

Conforms

Mesh   screen or equivalent

Particle   size

100-300nm

Conforms

Electron   micrographs

AshContent  

≤5.0%

4.50%

Eur.Ph.   <2.4. 16>

Loss   on drying 

≤5.0%

4.64%

Eur.Ph.7.0   [2.8. 17]

Heavy Metals

Total   Heavy Metals

≤10ppm

Conforms

Eur.Ph.7.0<2.2.58>   ICP-MS

Arsenic

≤2ppm

Conforms

Eur.Ph.7.0<2.2.58>   ICP-MS

Lead

≤3ppm

Conforms

Eur.Ph.7.0<2.2.58>   ICP-MS

Mercury

≤0.1ppm

Conforms

Eur.Ph.7.0<2.2.58>   ICP-MS

Cadmium

≤1ppm

Conforms

Eur.Ph.7.0<2.2.58>   ICP-MS

Microbiological   Tests

Total Plate Count

≤1000CFU/g

Conform

AOAC or equivalent

Yeast & Mold

≤100CFU/g

Conform

AOAC or equivalent

E. Coli.

Negative

Conform

AOAC or equivalent

Salmonella

Negative

Conform

AOAC   or equivalent

Staphylococcus

Negative

Conform

AOAC   or equivalent

Conclusion:

Comply with required standards.

Shelf   Life:

24 months if sealed and store away from direct sun   light.

Storage:

Store in a well-closed container away from moisture   and direct sunlight.

QC Manager:  Yanxia Li                                        Analyst:  Fan Sun             


Certificate of Analysis

Product Name: Lipo-Max™ Liposomal   Berberine Hydrochloride 50%

CAS No.: 633-65-8

Molecular Formula: C20H18NO4.Cl

Country of Origin: China

Molecular Weight: 371.81

 Batch Size: 70KG

 Batch No.: S20250512

Production Date: May 12, 2025

Expiry   Date: May 11, 2027

 

Test   Item

Specification

Result

Test   Method

Assay   of Berberine Hydrochloride

≥50%  

50.31%

HPLC

Appearance

Yellow   powder

Conforms

Visual

Odor                            

Natural   smell and Characteristic

Conforms

Organoleptic

Mesh   Size

100%   pass 80 mesh

Conforms

Mesh   screen or equivalent

Particle   size

100-300nm

Conforms

Electron   micrographs

AshContent  

≤5.0%

4.06%

Eur.Ph.   <2.4. 16>

Loss   on drying 

≤5.0%

4.13%

Eur.Ph.7.0   [2.8. 17]

Heavy Metals

Total   Heavy Metals

≤10ppm

Conforms

Eur.Ph.7.0<2.2.58>   ICP-MS

Arsenic

≤2ppm

Conforms

Eur.Ph.7.0<2.2.58>   ICP-MS

Lead

≤3ppm

Conforms

Eur.Ph.7.0<2.2.58>   ICP-MS

Mercury

≤0.1ppm

Conforms

Eur.Ph.7.0<2.2.58>   ICP-MS

Cadmium

≤1ppm

Conforms

Eur.Ph.7.0<2.2.58>   ICP-MS

Microbiological   Tests

Total Plate Count

≤1000CFU/g

Conform

AOAC or equivalent

Yeast & Mold

≤100CFU/g

Conform

AOAC or equivalent

E. Coli.

Negative

Conform

AOAC or equivalent

Salmonella

Negative

Conform

AOAC   or equivalent

Staphylococcus

Negative

Conform

AOAC   or equivalent

Conclusion:

Comply with required standards.

Shelf   Life:

24 months if sealed and store away from direct sun   light.

Storage:

Store in a well-closed container away from moisture   and direct sunlight.

QC Manager:  Yanxia Li                                        Analyst:  Fan Sun             



MATERIAL SAFETY DATA SHEET

 

According to Regulation (EC) No. 1907/2006 Version 1.0

Revision Date 30.08.2024

Print Date 25.09.2024

GENERIC EU MSDS - NO COUNTRY SPECIFIC DATA - NO OEL DATA

 

1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION

Product name: Lipo-Max™ Liposomal Berberine Hydrochloride

 

 

2. HAZARDS IDENTIFICATION

This substance is not classified as dangerous according to Directive 67/548/EEC.

 

3. COMPOSITION/INFORMATION ON INGREDIENTS

Synonyms: BERBERINE HCl; BERBERINE CHLORIDE HYDRATE; 6-DIHYDRO-9,10-DIMETHOXY-BENZO[G]-1,3-BENZODIOXOLO[5,6-A] QUINOLIZI NIUM, CHLORIDE; BERBERINE CHLORIDE; BERBERINE; BERBERINE HYDROCHLORIDE N-HYDRATE
Molecular Formula: C20H18ClNO4
Molecular Weight: 371.81 g/mol

CAS No.: 633-65-8

 

4. FIRST AID MEASURES

Eye Contact: No known effect on eye contact, rinse with water for a few minutes.

Skin Contact:
After contact with skin, wash immediately with plenty of water. Gently and thoroughly wash the contaminated skin with running water and non-abrasive soap. Be particularly careful to clean folds, crevices, creases, and groin. Cover the irritated skin with an emollient. If irritation persists, seek medical attention. Wash contaminated clothing before reusing.

Serious Skin Contact: Not available.

Inhalation: Allow the victim to rest in a well-ventilated area. Seek immediate medical attention.

Serious Inhalation: Not available.

Ingestion:

Do not induce vomiting. Loosen tight clothing such as a collar, tie, belt, or waistband. If the victim is not breathing, perform mouth-to-mouth resuscitation. Seek immediate medical attention.

Serious Ingestion: Not available.

 

5. FIRE AND EXPLOSION DATA

Flammability of the Product: May be combustible at high temperature.

Auto-Ignition Temperature: Not available.

Flash Points: Not available.

Flammable Limits: Not available.

Products of Combustion: Not available.

Fire Hazards in Presence of Various Substances: Not available.

Explosion Hazards in Presence of Various Substances:
Risks of explosion of the product in presence of mechanical impact: Not available. Risks of explosion of the product in presence of static discharge: Not available.

Fire Fighting Media and Instructions:
SMALL FIRE: Use DRY chemical powder.
LARGE FIRE: Use water spray, fog, or foam. Do not use water jet.

Special Remarks on Fire Hazards: Not available.

Special Remarks on Explosion Hazards: Not available.

 

6. ACCIDENTAL RELEASE MEASURES

Small Spill:

Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and dispose of according to local and regional authority requirements.

Large Spill:

Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and allow to evacuate through the sanitary system.

 

7. HANDLING AND STORAGE Precautions:

Keep away from heat. Keep away from sources of ignition. Empty containers pose a fire risk, evaporate the residue under a fume hood. Ground all equipment containing material. Do not breathe dust.

Storage:

Keep container dry. Keep in a cool place. Ground all equipment containing material. Keep container tightly closed. Keep in a cool, well-ventilated place. Combustible materials should be stored away from extreme heat and away from strong oxidizing agents.

 

8. EXPOSURE CONTROLS/PERSONAL PROTECTION

Engineering Controls:
Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommended exposure limits. If user operations generate dust, fume, or mist, use ventilation to keep exposure to airborne contaminants below the exposure limit.

Personal Protection: Safety glasses. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.

Personal Protection in Case of a Large Spill:
Splash goggles. Full suit. Dust respirator. Boots. Gloves. A self-contained breathing apparatus should be used to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling this product.

Exposure Limits: Not available.

 

9. PHYSICAL AND CHEMICAL PROPERTIES

Physical state and appearance: Solid Powder

Odor: Characteristic.

Taste: Not available.

Molecular Weight: 371.81

Color: Yellow

Boiling Point: No data

Melting Point: 145-150°C

Critical Temperature: Not available.

Specific Gravity: Not available.

Vapor Pressure: Not applicable.

Vapor Density: Not available.

Volatility: Not available.

Odor Threshold: Not available.

Water/Oil Dist. Coeff.: Not available.

Ionicity (in Water): Not available.

Dispersion Properties: See solubility in water.

Solubility: 1mg/ml at 25℃

 

10. STABILITY AND REACTIVITY DATA

Stability: The product is stable.

Instability Temperature: Not available.

Conditions of Instability: Not available.

Incompatibility with various substances: Not available.

Corrosivity: Not available.

Special Remarks on Reactivity: Not available.

Special Remarks on Corrosivity: Not available.

Polymerization: No.

 

11. TOXICOLOGICAL INFORMATION

Routes of Entry: Absorbed through skin. Eye contact. Inhalation. Ingestion.

Toxicity to Animals:
LD50: 295.86mg/kg. (oral mouse)
LC50: Not available.

Chronic Effects on Humans: Not available.

Other Toxic Effects on Humans: Slightly hazardous in case of skin contact (irritant), of inhalation (lung irritant).

Special Remarks on Toxicity to Animals: Not available.

Special Remarks on Chronic Effects on Humans: Not available.

Special Remarks on other Toxic Effects on Humans: Not available.

 

12. ECOLOGICAL INFORMATION

Ecotoxicity: Not available.

BOD5 and COD: Not available.

Products of Biodegradation:
Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise.

Toxicity of the Products of Biodegradation: Not available.

Special Remarks on the Products of Biodegradation: Not available.

 

13. DISPOSAL CONSIDERATIONS

Waste Disposal:

Waste must be disposed of in accordance with federal, state, and local environmental control regulations

14. TRANSPORT INFORMATION

DOT Classification: Not a DOT controlled material (United States).

Identification: Not applicable.

Special Provisions for Transport: Not applicable.

 

15. OTHER REGULATORY INFORMATION

Federal and State Regulations: No products were found.

Other Regulations: Not available.

Other Classifications:

WHMIS (Canada): Not controlled under WHMIS (Canada).

DSCL (EEC): This product is not classified according to the EU regulations.

HMIS (U.S.A.):

Health Hazard: 1
Fire Hazard: 1 Reactivity: 0
Personal Protection: E

National Fire Protection Association (U.S.A.):

Health: 1 Flammability: 1 Reactivity: 0 Specific hazard:

Protective Equipment:

Gloves.
Lab coat.
Dust respirator. Be sure to use an approved/certified respirator or equivalent. Safety glasses.

 

16. Other Information

References: Not available.

Other Special Considerations: Not available.

 

The information above is believed to be accurate and represents the best information currently available to us. However, we make no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assume no liability resulting from its use. Users should make their own investigations to determine the suitability of the information for their purposes.


Specification

Product Name

Lipo-Max™ Liposomal Berberine   Hydrochloride 50%

CAS No.

633-65-8

Molecular Formula

C20H18NO4.Cl

Country of Origin

China

Molecular Weight

371.81

 

Assay

Specification

Test Method

Assay   of Berberine Hydrochloride

≥50%  

HPLC

Appearance

Yellow   powder

Visual

Odor                            

Natural   smell and characteristic

Organoleptic

Mesh   Size

100%   pass 80 mesh

Mesh   screen or equivalent

Particle   size

100-300nm

Electron   micrographs

Ash   Content

≤5.0%

Eur.Ph.   <2.4. 16>

Loss   on drying 

≤5.0%

Eur.Ph.7.0   [2.8. 17]

Total   Heavy Metals

≤10ppm

Eur.Ph.7.0<2.2.58>   ICP-MS

Arsenic

≤2ppm

Eur.Ph.7.0<2.2.58>   ICP-MS

Lead

≤3ppm

Eur.Ph.7.0<2.2.58>   ICP-MS

Mercury

≤0.1ppm

Eur.Ph.7.0<2.2.58>   ICP-MS

Cadmium

≤1ppm

Eur.Ph.7.0<2.2.58>   ICP-MS

Total   Plate Count

≤1000CFU/g

AOAC   or equivalent

Yeast   & Mold

≤100CFU/g

AOAC   or equivalent

E.   Coli.

Negative/10g

AOAC   or equivalent

Salmonella

Negative/10g

AOAC   or equivalent

Staphylococcus

Negative10/g

AOAC   or equivalent

 

Packing and Storage

Packing

Pack in paper-drums and two plastic   bags inside. Net weight: 25kg/drum

Storage

Clean & dry place. Do not freeze.   Keep away from straight light and heat.

Shelf Life

24 months if store under the   conditions above and stay in original packaging.

 

Note: Non-GMO, Allergen Free, BSE/TSE Free.