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Comprehensive List of USP-Certified Aluminum Hydroxide Products Manufactured in the USA

Ensuring Quality and Compliance in Pharmaceutical Applications

aluminum hydroxide pharmaceutical products

Key Takeaways

  • High Quality Assurance: All listed products are USP-certified, ensuring they meet stringent quality standards essential for pharmaceutical and medical use.
  • Diverse Manufacturers: A wide range of reputable manufacturers across the USA offer aluminum hydroxide products, catering to various application needs.
  • Versatile Applications: These products are utilized in multiple industries, including pharmaceuticals, food-grade applications, and chemical manufacturing, highlighting their versatility.

Introduction to Aluminum Hydroxide

Aluminum hydroxide is an inorganic compound with the formula Al(OH)3. It is commonly used in various industries due to its versatility and effectiveness. In the pharmaceutical industry, it serves as an antacid to neutralize stomach acid, providing relief from conditions such as heartburn and acid indigestion. Additionally, aluminum hydroxide is utilized as an adjuvant in vaccines, enhancing the body’s immune response.

Importance of USP Certification

The United States Pharmacopeia (USP) sets critical quality standards for medicines, food ingredients, and dietary supplements. USP certification indicates that a product has been rigorously tested and meets the established standards for purity, strength, and consistency. For aluminum hydroxide products, USP certification ensures they are safe for consumption and effective in their intended applications, particularly in pharmaceutical formulations.

List of USP-Certified Aluminum Hydroxide Products Made in the USA

The following table provides a comprehensive list of aluminum hydroxide products that are manufactured in the USA and hold USP certification. Each entry includes the product name, manufacturer, certification details, and additional notes to aid in selection based on specific needs.

Product Name Manufacturer Certification Details Additional Notes
Dried Aluminum Hydroxide Gel (200 mg) USP USP Certificate or Product Information Sheet Available for purchase directly from the USP store.
Rugby 320 mg Aluminum Hydroxide Gel, USP Rugby Laboratories USP Certified Mint-flavored antacid liquid for heartburn and acid indigestion relief.
Dried Aluminum Hydroxide Gel USP Spectrum Chemical USP Certification; Manufactured under cGMP standards per 21CFR part 211 in FDA-registered facilities Used as an antacid; meets pharmaceutical grade requirements.
Aluminum Hydroxide USP Gel American Elements USP and EP/BP Certification; Meets various pharmaceutical and food-grade standards Produced in the USA; available in multiple grades and custom packaging.
Aluminum Hydroxide API Products Rochem International, Inc. USP Certification; FDA and GMP Compliant Listed as being sourced and produced in the USA; inquire for specific product forms.
ALUMINUM HYDROXIDE GEL DRIED USP Fagron - Letco Medical USP Certified Contact customer service for availability.
ALUMINUM HYDROXIDE USP Dry Gel Powder UPI Chem USP Certified Used in wet granulated antacid tablets and liquid antacid suspensions.
Dried Aluminum Hydroxide Gel Anmol Chemicals USP Certified Available in various grades including IP, BP, EP, Ph Eur, USP, NF, JP, FCC, and Food Grade.
Dried Aluminum Hydroxide Gel Mubychem USP Certified Used to treat symptoms of increased stomach acid.
Dried Aluminum Hydroxide Gel Global Chemicals Corp USP Certified Fine white colorless amorphous powder used in antacid tablets and liquid suspensions.
Barcroft 0325 Dried Al Hyd Gel USP Azelis USP Certified Fine powder used in wet granulation processes for antacid tablets.

Detailed Overview of Manufacturers

1. Rugby Laboratories

Rugby Laboratories is renowned for producing high-quality pharmaceutical products. Their Aluminum Hydroxide Gel, USP, comes in a convenient liquid form, making it easy to administer for heartburn relief. The mint flavor enhances palatability, ensuring compliance in patient use.

2. Spectrum Chemical

Spectrum Chemical manufactures Dried Aluminum Hydroxide Gel, USP, under stringent cGMP standards. Their products are integral in pharmaceutical formulations, ensuring consistency and reliability in medicinal preparations.

3. American Elements

American Elements offers a versatile range of Aluminum Hydroxide USP Gel products. Their adherence to USP and EP/BP certifications ensures that their products meet diverse pharmaceutical and food-grade requirements, catering to a broad spectrum of applications.

4. Rochem International, Inc.

Rochem International provides Aluminum Hydroxide API Products that comply with USP standards and FDA regulations. Their commitment to quality makes them a trusted supplier for pharmaceutical manufacturers seeking reliable excipients.

5. Fagron - Letco Medical

Fagron - Letco Medical specializes in pharmaceutical compounding agents. Their ALUMINUM HYDROXIDE GEL DRIED USP product is specifically formulated for compounding pharmacies, ensuring precise formulations for patient-specific medications.

6. UPI Chem

UPI Chem's ALUMINUM HYDROXIDE USP Dry Gel Powder is a key ingredient in antacid formulations. Its fine powder ensures uniform distribution in tablets and suspensions, enhancing product efficacy and consumer satisfaction.

7. Anmol Chemicals

Anmol Chemicals offers a range of Dried Aluminum Hydroxide Gel products in various grades, including pharmaceutical and food-grade specifications. Their diverse product offerings make them suitable for multiple industrial applications.

8. Mubychem

Mubychem's Dried Aluminum Hydroxide Gel is designed to alleviate symptoms associated with excess stomach acid. Its USP certification guarantees its effectiveness and safety in medicinal use.

9. Global Chemicals Corp

Global Chemicals Corp produces high-purity Dried Aluminum Hydroxide Gel, USP, suitable for both antacid tablets and liquid suspensions. Their commitment to quality ensures consistency in pharmaceutical applications.

10. Azelis

Azelis' Barcroft 0325 Dried Al Hyd Gel USP is a fine powder utilized in wet granulation processes for tablet manufacturing. Its quality and consistency are paramount for effective pharmaceutical production.

Applications and Uses of Aluminum Hydroxide

Aluminum hydroxide's versatility makes it a valuable component in several industries:

Pharmaceuticals

Primarily used as an antacid, aluminum hydroxide neutralizes excess stomach acid, providing relief from discomfort associated with heartburn and indigestion. Additionally, it serves as an adjuvant in vaccines, enhancing the immune response by promoting a more robust antibody production.

Food Industry

In the food industry, aluminum hydroxide is utilized as a food additive, serving purposes such as acidity regulation and anti-caking agent. Its food-grade certification ensures its safety for consumption.

Chemical Manufacturing

Aluminum hydroxide is employed in chemical manufacturing processes, including as a flame retardant and filler in plastics. Its thermal stability and inertness contribute to its effectiveness in these applications.

Water Treatment

In water treatment, aluminum hydroxide acts as a flocculant, aiding in the removal of impurities by causing particles to clump together for easier filtration.

Ensuring Quality and Compliance

Choosing USP-certified aluminum hydroxide products guarantees adherence to high-quality standards, essential for safety and efficacy in various applications. Manufacturers such as Spectrum Chemical, Rugby Laboratories, and American Elements lead the industry by maintaining rigorous quality controls and compliance with FDA regulations.

Quality Control Measures

Manufacturers employ comprehensive quality control measures, including thorough testing for purity, strength, and consistency. These measures ensure that each batch of aluminum hydroxide meets the stringent requirements set by USP, thereby ensuring reliable performance in its intended applications.

Regulatory Compliance

Adhering to regulatory standards is paramount in the production of aluminum hydroxide. Compliance with current Good Manufacturing Practices (cGMP) and adherence to guidelines outlined in 21 CFR Part 211 ensure that products are safe for use in pharmaceuticals and other sensitive industries.

Conclusion

Aluminum hydroxide plays a critical role across various industries, particularly in pharmaceuticals where its efficacy as an antacid and vaccine adjuvant is invaluable. The assurance of USP certification elevates its reliability, guaranteeing that products meet the highest standards of quality and safety. Manufacturers in the USA, including Rugby Laboratories, Spectrum Chemical, and American Elements, offer a diverse range of USP-certified aluminum hydroxide products tailored to meet the specific needs of different applications. By selecting USP-certified products, consumers and professionals alike can ensure optimal performance and compliance with regulatory standards.

References


Last updated January 21, 2025
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