Berberine Hydrochloride: USP Standard, Specification, Benefits and Applications

Berberine Hydrochloride is a high-purity active alkaloid extracted from Rhizoma Coptidis. Adopting standardized and rigorous production procedures, the raw coptis materials are first crushed, extracted with sulfuric acid solution, precipitated with hydrochloric acid to obtain crude products, and further refined and purified to produce finished berberine hydrochloride powder.

The final product is a fine yellow powder with a slight characteristic odor and an extremely bitter taste. It is soluble in water but practically insoluble in benzene, ether, and chloroform. With stable physical and chemical properties and high safety, berberine hydrochloride is widely used as a professional antibacterial raw material for clinical pharmaceutical and health care product manufacturing.

Berberine Hydrochloride USP Test Specifications & Test Report

Our berberine hydrochloride strictly complies with USP32/USP34 official standards. All batches are tested in accordance with United States Pharmacopeia regulations, with full indicators meeting industry qualification requirements. The detailed quality test data is shown below:

Analysis Item	Specification	Result	Test Method
Berberine	NLT 95%	95.12%	HPLC
Appearance	Fine Yellow Powder	Complies	Visual
Odor	Characteristic	Complies	Olfactory
Sieve Analysis	100% pass 80mesh	Complies	80 mesh Screen
Loss on Drying	5% Max	2.87%	USP32<561>
Ash	5% Max	1.13%	USP32<731>
Arsenic (As)	NMT 1ppm	0.12ppm	USP32<231>
Cadmium(Cd)	NMT 0.5ppm	0.13ppm	USP32<231>
Lead (Pb)	NMT 0.5ppm	0.06ppm	USP32<231>
mercury (Hg)	NMT0.1ppm	0.03ppm	USP32<231>
Residual solvents	Meet USP32 Requirments	Conforms	USP32<467>
Heavy Metals	10ppm Max	Complies	USP32<231>
Residual pesticides	Meet USP32 Requirments	Conforms	USP32<561>
Total Plate Count	1000cfu/g Max	Complies	USP34<61>
Yeast & Mold	100cfu/g Max	Complies	USP34<61>
E.Coli	Negative	Complies	USP34<62>
Staphylococcus	Negative	Conforms	USP34<62>
Staphylococcus aureus	Negative	Complies	USP34<62>
Conclusion:	Meet the USP standard

Core Functions & Benefits of Berberine Hydrochloride

As the core active ingredient of Rhizoma Coptidis extract, berberine hydrochloride possesses multiple natural pharmacological activities and health benefits, widely recognized in pharmaceutical and health industries:

Clears Heat and Detoxifies: It inherits the traditional medicinal properties of coptis extract, featuring excellent heat-clearing and detoxifying effects, helping relieve internal heat and body inflammation.

Regulates Smooth Muscle Activity: Effectively relaxes vascular smooth muscles to support vascular health, and excites multiple body smooth muscles including bladder muscle, bronchial muscle and gastrointestinal muscle to maintain normal physiological functions.

Powerful Antibacterial Activity: Berberine hydrochloride is a classic natural antibacterial ingredient, which can inhibit and eliminate a variety of harmful bacteria, providing effective antibacterial protection for the human body.

Main Clinical & Industrial Applications

Clinical Pharmaceutical Application

It is widely used in clinical treatment of various inflammatory and bacterial infectious diseases, including bacterial dysentery, lung abscess, brucellosis, acute tonsillitis, maxillary sinusitis, oral and maxillofacial inflammation, as well as gastroenteritis and other gastrointestinal inflammatory diseases.

Health Care Product Industry

With stable antibacterial and anti-inflammatory properties and natural plant-derived advantages, high-purity berberine hydrochloride powder is commonly used as a core raw material for functional health supplements, supporting daily body inflammation regulation and intestinal health maintenance.

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