Pharmaceutical Grade Chlorhexidine Acetate (Chlorhexidine Acetate) Disinfectant and Antiseptic Active Pharmaceutical Ingredient (API), CP Pharmacopoeia Standard

Pharmaceutical Grade Chlorhexidine Acetate (Chlorhexidine Acetate) Disinfectant and Antiseptic Bulk Drug CP Edition Pharmacopoeia Standard

Chlorhexidine Acetate is an antibacterial agent commonly used in the medical industry, widely applied in areas such as skin disinfection, oral care, and wound cleaning. As a potent antibacterial disinfectant, chlorhexidine acetate holds extensive application value in hospitals, clinics, and home care, particularly demonstrating significant effectiveness in preventing and treating skin infections and oral inflammations. In pharmaceutical-grade applications, the quality control of chlorhexidine acetate is especially important. The "2020 Edition of the Chinese Pharmacopoeia" (CP Edition) provides detailed regulations on the quality standards of chlorhexidine acetate to ensure its safety and efficacy in medical applications.

Uses of Chlorhexidine Acetate:

- Pharmaceutical Grade Chlorhexidine Acetate: Primarily used in the medical field, such as for skin and mucous membrane disinfection, wound disinfection, medical device sterilization, and as a bacteriostatic agent in pharmaceuticals. It exerts bactericidal and disinfecting effects through direct action on the human body, requiring extremely high standards for product safety and efficacy.

- Food Grade Chlorhexidine Acetate: Mainly used in the food industry as a food additive for sterilization and preservation during food processing to extend shelf life and ensure microbial safety. It is generally not directly applied to the human body but enters indirectly through food additives, so its usage scope and limits in food are clearly defined.

Regulatory Requirements for Chlorhexidine Acetate:

- Pharmaceutical Grade: Subject to strict oversight by drug regulatory authorities, with a comprehensive regulatory system covering production licensing, product registration, and post-market adverse reaction monitoring to ensure drug quality, safety, and efficacy.

- Food Grade: Regulated by food regulatory agencies, focusing on compliance, safety in food use, and its impact on food quality.

Pharmaceutical-grade and food-grade chlorhexidine acetate differ significantly in quality standards, production processes, uses, and regulatory requirements. The appropriate grade should be selected based on specific needs, and the two should not be confused to avoid adverse consequences.

Pharmaceutical Grade Chlorhexidine Acetate (Chlorhexidine Acetate) Disinfectant and Antiseptic Bulk Drug CP Edition Pharmacopoeia Standard

CP Edition Quality Standards for Pharmaceutical Grade Chlorhexidine Acetate Bulk Drug

1. Appearance and Properties

Pharmaceutical-grade chlorhexidine acetate should be a colorless or pale yellow transparent liquid, odorless, with a characteristic pungent odor. Its appearance should be clear and transparent, free of precipitates or suspended matter, meeting pharmacopoeial quality requirements.

2. Identification

The pharmacopoeia stipulates that chlorhexidine acetate must meet the following identification criteria:

- Ultraviolet Absorption Spectrum Identification: Chlorhexidine acetate should exhibit characteristic absorption peaks in the ultraviolet spectrum, aiding in confirming its chemical structure.

- Reaction with Water: The aqueous solution of chlorhexidine acetate should demonstrate strong antibacterial activity, indicating its active ingredients comply with pharmacopoeial requirements.

3. Assay

The effective content of chlorhexidine acetate must meet specified standards. Typically, its content is determined using high-performance liquid chromatography (HPLC). The pharmacopoeia requires the content of chlorhexidine acetate to be between 95.0% and 105.0% of the nominal value to ensure stable efficacy.

4. Moisture Content

The moisture content in pharmaceutical-grade chlorhexidine acetate must not exceed 5.0%. Excessive moisture may lead to degradation, affecting its stability and disinfecting efficacy.

5. pH Value

The solution of chlorhexidine acetate should have appropriate acidity, typically with a pH value between 4.5 and 6.5. pH values that are too low or too high may impact its efficacy and stability.

6. Impurity Testing

The pharmacopoeia imposes strict regulations on impurity content in chlorhexidine acetate. Common impurities include degradation products of chlorhexidine and other harmful substances. Chlorhexidine acetate should not contain visible impurities, and its heavy metal and arsenic content should be below specified limits (e.g., arsenic not exceeding 2 ppm, heavy metals not exceeding 20 ppm).

7. Microbial Limits

As an antibacterial drug, chlorhexidine acetate must strictly control microbial contamination during production and storage to ensure it is free of pathogenic microorganisms. The pharmacopoeia requires pharmaceutical-grade chlorhexidine acetate to pass sterility testing, and the total microbial count must meet standard requirements.