Pharmaceutical Grade Ammonium Chloride National Drug Standard API Pharmacopoeial Grade Ammonium Chloride CDE Registered for Preparations with Content Above 99%

Ammonium Chloride is a commonly used pharmaceutical active ingredient widely applied in medical, food, and industrial fields. As a medication, it is often used as an expectorant to help stimulate bronchial fluid secretion, making phlegm easier to expel. Additionally, ammonium chloride is clinically used to treat metabolic alkalosis and serves as an acidifying agent in injections and pharmaceutical preparations to adjust pH. In pharmaceutical-grade applications, ensuring the purity and quality of ammonium chloride meets the standards of the "2020 Edition of the Chinese Pharmacopoeia" is crucial for guaranteeing its efficacy and safety.

Pharmaceutical Grade Ammonium Chloride Chinese Pharmacopoeia Quality Standards:

1. Appearance and Characteristics

Ammonium chloride should be a colorless or white crystalline powder or granules with a slightly salty taste and a cooling sensation. Its appearance should be clean, dry, and free of any visible impurities or foreign matter to ensure safety and effectiveness in use.

2. Identification

Identification methods for ammonium chloride include:

- Chloride Ion Identification: Testing the ammonium chloride solution with reagents should produce a white precipitate, soluble in dilute nitric acid, indicating the presence of chloride ions.

- Ammonium Ion Identification: Under the action of sodium hydroxide, the ammonium chloride solution releases ammonia gas, turning moist red litmus paper blue, indicating the presence of ammonium ions.

3. Assay

The pharmacopoeia stipulates that the effective content of ammonium chloride should be between 99.0% and 100.5% (calculated on a dried basis), determined by titration to ensure the stability of its efficacy. The assay is a key step in ensuring that pharmaceutical-grade ammonium chloride meets quality standards.

4. Acidity and Alkalinity (pH Value)

The pH value of the ammonium chloride solution (1% aqueous solution) should be between 4.6 and 6.0. This pH range helps maintain its stability and adaptability to various pharmaceutical formulation requirements.

5. Loss on Drying

The moisture content of ammonium chloride must not exceed 0.5%. The loss on drying test is used to detect the content of volatile substances, such as moisture, to ensure stability during storage and use.

6. Residue on Ignition

The pharmacopoeia stipulates that the residue on ignition (i.e., ash content) of ammonium chloride must not exceed 0.1%, ensuring that the content of inorganic impurities remains within acceptable limits.

7. Heavy Metal Content

The heavy metal content in ammonium chloride must be below the pharmacopoeia-specified limit (generally not exceeding 10 ppm) to prevent adverse effects on human health from heavy metal contamination.

8. Arsenic Salt Content

As a toxic element, the arsenic content in ammonium chloride must be below 2 ppm to comply with drug safety standards.

Pharmaceutical Grade Ammonium Chloride National Drug Standard API Pharmacopoeial Grade Ammonium Chloride CDE Registered for Preparations with Content Above 99%

As an important pharmaceutical active ingredient, the quality of ammonium chloride must strictly comply with the standards of the Chinese Pharmacopoeia to ensure its safety and effectiveness in medical applications. Shaanxi Mingcheng Pharmaceutical Co., Ltd., with its professional technology and stringent quality management, provides high-quality ammonium chloride APIs and other pharmaceutical excipients to the domestic and international pharmaceutical industry, helping customers enhance the quality and efficiency of their drugs. The company consistently adheres to the principles of innovation and quality, continuously offering superior API solutions to the global pharmaceutical market.