In the pharmaceutical industry, the quality and reliability of excipients are paramount. galenIQ™ 981 (Isomalt Ph.Eur., USP-NF, JP) is one such excipient, recognized for its consistent performance and compliance with multiple international pharmacopoeial standards. This article delves into the specifications, properties, and regulatory compliance of galenIQ™ 981, highlighting why it is a preferred choice in various pharmaceutical formulations.

What is galenIQ™ 981?

galenIQ™ 981 is a sieved isomalt, a disaccharide alcohol derived from sucrose, known for its role as a bulk sweetener and excipient in pharmaceutical applications. It is a mixture of two components: 6-O-a-D-glucopyranosyl-D-glucitol (1,6-GPS) and 1-O-a-D-glucopyranosyl-D-mannitol (1,1-GPM). The product is designed to meet the stringent requirements of the European Pharmacopoeia (Ph.Eur.), the United States Pharmacopeia-National Formulary (USP-NF), and the Japanese Pharmacopoeia (JP), ensuring its high quality and reliability.

Physical and Chemical Characteristics

galenIQ™ 981 is characterized by its white or almost white appearance, available as a powder or granules. It is freely soluble in water but practically insoluble in ethanol, making it suitable for various pharmaceutical uses. The product's composition is carefully controlled, with the 1,6-GPS content ranging between 75% and 80% on an anhydrous basis, ensuring consistent performance in formulations.

Particle Size Distribution

The particle size distribution of galenIQ™ 981 is tightly controlled, with a maximum of 5% of particles exceeding 2000 µm and a maximum of 15% smaller than 200 µm. This distribution is crucial for ensuring the uniformity of the excipient in pharmaceutical formulations, contributing to the consistent quality of the final product.

Pharmacopoeial Compliance

galenIQ™ 981 is fully compliant with the pharmacopoeial standards of the Ph.Eur., USP-NF, and JP. Several identification tests, including HPLC chromatogram and thin layer chromatography (TLC), confirm the presence and quality of the isomalt components. The product also passes the pyrocatechol test, which results in a pink color formation, further validating its identity.

Specifications and Assays

• Assay Content: The total content of 1,6-GPS and 1,1-GPM is maintained between 98.0% and 102.0% on an anhydrous basis. Both 1,6-GPS and 1,1-GPM must be present at a minimum of 3.0% each, ensuring the product's efficacy and consistency.
• Conductivity: The maximum conductivity allowed is 20 µS/cm, indicating the product's purity and low ionic content.
• Optical Rotation: The specific optical rotation is approximately +92°, confirming the structural integrity of the isomalt.
• Reducing Sugars: The content of reducing sugars, calculated as glucose, is kept below 0.3% on an anhydrous basis, ensuring minimal impurity levels.

Related Substances and Purity

galenIQ™ 981 maintains stringent limits on related substances, with the total allowed not exceeding 2.0% on an anhydrous basis. Specific related substances, such as D-mannitol, D-sorbitol, trehalulose, and isomaltulose, are each limited to a maximum of 0.5%. These rigorous controls ensure the product's high purity and suitability for sensitive pharmaceutical applications.

Microbial and Elemental Impurities

The microbial quality of galenIQ™ 981 is ensured through strict limits on total mesophilic bacteria, yeasts, moulds, and coliforms, including E. coli. Additionally, the product complies with guidelines for elemental impurities, including a maximum nickel content of 1 mg/kg and heavy metals (as lead) not exceeding 10 mg/kg.

Regulatory Compliance and Certifications

galenIQ™ 981 is produced in Germany under strict regulatory compliance with both German and European laws. It is free from genetically modified organisms (GMOs) and allergens, making it safe for a wide range of pharmaceutical and food applications. The product is also suitable for vegetarian and vegan formulations, as it is manufactured without raw materials or processing aids of animal origin.

Moreover, galenIQ™ 981 is certified Kosher, Halal, and ISO 9001, adding to its credibility and acceptance in various markets.

Storage and Shelf Life

To maintain its quality, galenIQ™ 981 should be stored in well-closed or original packaging. The product boasts a shelf life of five years when stored in its original unopened packaging, validated for different climate zones, ensuring long-term stability.

Conclusion

galenIQ™ 981 is a high-quality, reliable excipient that meets the demanding standards of the pharmaceutical industry. Its consistent performance, compliance with international pharmacopoeial standards, and broad regulatory acceptance make it an ideal choice for various pharmaceutical applications. Whether for tablets, capsules, or other dosage forms, galenIQ™ 981 offers a dependable solution for formulators seeking excellence in their products.

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