In the pharmaceutical industry, the selection of raw materials is governed by stringent quality and purity standards. Citric Acid Monohydrate (CAS 5949-29-1), when used as a pharmaceutical excipient or active ingredient component, must meet pharmacopoeial requirements such as USP and BP. As a trusted manufacturer and supplier, we focus on producing pharmaceutical-grade Citric Acid Monohydrate that adheres to these rigorous specifications, ensuring the safety and efficacy of your final drug products.

Pharmaceutical Grade Requirements: Purity Above All

Pharmaceutical-grade Citric Acid Monohydrate is characterized by its exceptionally high purity and low levels of impurities. Key specifications typically include minimal moisture content, low limits for heavy metals (such as lead and arsenic), absent or trace amounts of sulfates, chlorides, and oxalates, and a clear, colourless solution. The pharmacopoeial standards set by the USP (United States Pharmacopeia) and BP (British Pharmacopoeia) are critical benchmarks. Manufacturers must provide Certificates of Analysis (CoA) detailing compliance with these standards. When you intend to buy Citric Acid Monohydrate for pharmaceutical applications, verifying these compliance documents is a non-negotiable step.

Key Functions in Pharmaceutical Formulations

Citric Acid Monohydrate plays several vital roles in pharmaceutical formulations. It is frequently used as a pH adjusting agent and buffer, crucial for maintaining the stability and solubility of many active pharmaceutical ingredients (APIs). Many APIs degrade at extreme pH values, making Citric Acid Monohydrate an excellent choice for creating stable liquid formulations, syrups, and effervescent tablets. Its slightly sour taste can also help to mask the bitter taste of certain medications, improving patient compliance. Furthermore, its chelating properties can help prevent metal-catalyzed degradation reactions within a formulation.

Selecting a Reliable Manufacturer and Supplier

Choosing the right manufacturer for pharmaceutical-grade Citric Acid Monohydrate is critical for regulatory compliance and product integrity. A reputable supplier will not only offer products that meet USP/BP standards but will also have robust quality management systems in place, often evidenced by ISO certifications. Transparency regarding the manufacturing process, traceability of raw materials, and a strong regulatory affairs team are also key indicators of a reliable partner. When seeking to buy Citric Acid Monohydrate for pharmaceutical use, inquire about their GMP (Good Manufacturing Practices) compliance and their experience in supplying to the pharmaceutical sector. We, as a dedicated manufacturer, are equipped to meet these demanding requirements, offering you a dependable source for your essential pharmaceutical ingredients.

We invite pharmaceutical developers and manufacturers to contact us for detailed specifications, pricing, and sample requests for our high-purity Citric Acid Monohydrate. Partner with us to ensure the quality and compliance of your pharmaceutical products.