Pharmaceutical-grade Artificial Bezoar National Drug Approval Number Z Medical-grade Artificial Bezoar Active Pharmaceutical Ingredient (API) Grade CDE Filing Number A

Pharmaceutical Grade Artificial Bezoar National Drug Approval Number Medical Grade Artificial Bezoar Active Pharmaceutical Ingredient Grade CDE Registration Number A

Artificial bezoar is an important medicinal raw material widely used in traditional Chinese medicine and modern pharmaceutical preparations. As a substitute for natural bezoar, artificial bezoar demonstrates excellent efficacy and safety, while also offering advantages in cost and stability. The "Chinese Pharmacopoeia 2020 Edition" (CP Edition) sets strict quality standards for pharmaceutical-grade artificial bezoar to ensure its safe, effective, and compliant application in the pharmaceutical industry.

1. Properties of Artificial Bezoar

Artificial bezoar is a yellow-brown or orange-yellow powder with the characteristic odor of natural bezoar and exhibits certain solubility in both water and ethanol. It is a complex chemical mixture primarily composed of bilirubin, bile acids, cholesterol, and trace elements, possessing anti-inflammatory, antioxidant, and antipyretic effects.

2. Quality Standards

According to the "Chinese Pharmacopoeia 2020 Edition," artificial bezoar must meet the following quality requirements:

- Identification: The components of artificial bezoar can be identified through microscopic observation or chemical analysis methods, such as ultraviolet-visible spectrophotometry to analyze its characteristic absorption peaks.

- Content Determination:

- Bilirubin content must be within the range of 35.0%-41.0%, which is a key indicator for judging the quality of artificial bezoar.

- Bile acid content must reach 10.0%-15.0%.

- Impurity Limits:

- Heavy metal limits should be less than 10 ppm to ensure safety.

- Arsenic salt content must not exceed 2 ppm to prevent potential toxicity.

- Microbial Limits:

- As a medicinal raw material, artificial bezoar requires strict control of microbial contamination to ensure that total bacterial count, molds, and yeasts meet pharmacopoeia requirements.

- Loss on Drying: Should not exceed 5.0% to ensure product stability.

3. Uses

Artificial bezoar is primarily used in various pharmaceutical preparations to exert effects such as clearing heat and detoxifying, calming the mind, anticonvulsant, and anti-inflammatory. Common dosage forms include capsules, tablets, and injections, such as Bezoar Detoxification Tablets and Bezoar Heart-Clearing Pills.

Pharmaceutical Grade Artificial Bezoar National Drug Approval Number Medical Grade Artificial Bezoar Active Pharmaceutical Ingredient Grade CDE Registration Number A

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