Spiga Nord > Glycerine for the pharmaceutical sector
Pharmaceutical-grade vegetable glycerin is one of the most widely used excipients in the pharmaceutical and nutraceutical industries due to its high purity, excellent safety profile, and versatility in formulation. Used as an excipient in medicines, galenic preparations, dietary supplements, and medical devices (where applicable), it performs essential functions as a solvent, humectant, stabilizer, and viscosity-enhancing agent, contributing to the quality, stability, and reproducibility of formulations. Spiga Nord produces excipient-grade vegetable glycerin, refined according to rigorous quality standards and compliant with the requirements of the European Pharmacopoeia (EP). Thanks to a controlled production process, each batch guarantees high purity, full traceability, and dedicated technical documentation, meeting the needs of pharmaceutical and nutraceutical manufacturers as well as distributors of high-value-added raw materials. Our product line includes products with concentrations of 99.7% and 86.5%, developed to meet various production and regulatory requirements while maintaining high quality standards and the consistent supply essential for regulated markets. Each product is derived exclusively from plant-based glycerine that has not been chemically modified, complies with REACH requirements, and is manufactured in a dedicated production facility.
The pharmaceutical industry operates within one of the most stringent regulatory environments in the world. In addition to the quality of the excipient, manufacturers and Regulatory Affairs departments require suppliers who can ensure pharmacopeial compliance, full traceability, documented risk assessments, and a structured quality management system.
The growing focus on nitrosamines, elemental impurities (ICH Q3D), residual solvents, contaminants, PFAS, TSE/BSE, GMOs, and numerous other regulatory issues makes it essential to have a partner who can provide not only a compliant product but also comprehensive documentation support.
For this reason, the selection of pharmaceutical-grade glycerine cannot be based solely on the product’s chemical characteristics. Key factors include the availability of a complete Certificate of Analysis, compliance with the European Pharmacopoeia, validation of the shelf life, batch traceability, and the implementation of quality systems that comply with Good Manufacturing Practices (GMP) for Pharmaceutical Excipients.
Spiga Nord addresses these challenges through an approach focused on quality, risk management, and regulatory compliance, providing its clients with comprehensive and constantly updated technical documentation.
Regulatory Compliance
Regulatory compliance is one of the cornerstones of Spiga Nord’s offerings. Our pharmaceutical-grade glycerine are backed by comprehensive technical documentation and a quality system designed to meet the requirements of regulated markets. Key features include:Partnering with Spiga Nord means choosing a partner that specialises in producing vegetable glycerine for pharmaceutical use, combining chemical expertise, regulatory experience, and industrial reliability.
Our production process is dedicated exclusively to the refining of vegetable glycerine and is managed through a structured quality system that includes an in-house laboratory, supplier qualification procedures, extensive analytical testing of raw materials and finished products, continuous improvement programs, nonconformity management, CAPA systems, internal audits, and complete segregation of raw materials and finished products.
Each batch is identified using a unique traceability system that allows for the tracing of the raw materials used, while each shipment is accompanied by the technical documentation required by the industry, including Certificates of Analysis, Product Dossiers, and relevant regulatory declarations. Stability studies conducted in accordance with EMA guidelines support a shelf life of 24 months, and, when requested, Spiga Nord also offers a retesting service to confirm the compliance of products nearing their expiration date.
For Spiga Nord, pharmaceutical-grade glycerine is not just an excipient: it is the result of a controlled supply chain, a rigorous quality system, and constant attention to evolving international regulations. This approach allows us to support our customers as a technical and regulatory partner, offering reliable solutions for the development and production of pharmaceutical and nutraceutical formulations that meet the highest quality standards.
Plant-derived glycerol diluted to 86.5% concentration with purified water, conforming to European Pharmacopoeia (EP) standards for use as a pharmaceutical excipient and cosmetic ingredient. Its reduced viscosity facilitates cold processing and handling while maintaining strong emollient, humectant, and carrier properties for oral liquids, syrups, and dermocosmetics.
Refined plant-based glycerol (≥99.7%) graded as an EP pharmaceutical excipient and backed by Kosher and Halal certifications. Formulated for the stringent demands of the pharmaceutical and advanced cosmetic industries, it provides exceptional hydrating and carrying properties alongside strict ethical and regulatory compliance.
Refined, GMO-free glycerol of 100% vegetable origin featuring a purity above 99.7%, fully compliant with European Pharmacopoeia (EP) standards. Highly recommended for cosmetic and personal care formulations, it performs as a powerful moisturizer, humectant, and solvent, ensuring high skin tolerability and remarkable thermal stability.