Spiga Nord > Glycerine for the pharmaceutical sector
Pharmaceutical-grade vegetable glycerine serves as a versatile excipient in pharmaceutical and nutraceutical formulations. Manufacturers use it in medicines, galenic preparations, dietary supplements and medical devices, where applicable. It acts as a solvent, humectant, stabiliser and viscosity-enhancing agent. These functions support formulation quality, stability and reproducibility.
Spiga Nord produces excipient-grade vegetable glycerine and applies rigorous quality standards throughout the refining process. Its products meet the requirements of the European Pharmacopoeia (Ph. Eur.). The company supports pharmaceutical manufacturers, nutraceutical companies and distributors of high-value raw materials.
Spiga Nord controls every stage of production. Each batch offers high purity, full traceability and dedicated technical documentation. The product range includes 99.7% and 86.5% glycerol concentrations. These grades address different production and regulatory requirements while maintaining consistent quality and supply.
Spiga Nord produces every grade exclusively from plant-based glycerine. The company does not chemically modify the glycerol molecule. Its products comply with REACH requirements, and a dedicated production facility manages the entire manufacturing process.
The pharmaceutical industry operates within a highly regulated environment. Manufacturers and Regulatory Affairs teams require more than excipient quality. They also need pharmacopeial compliance, full traceability, documented risk assessments and a structured quality management system.
Regulatory teams now focus closely on nitrosamines, elemental impurities under ICH Q3D, residual solvents and contaminants. They also evaluate PFAS, TSE/BSE and GMO risks. A qualified supplier must therefore provide both a compliant product and comprehensive documentation.
Manufacturers cannot select pharmaceutical-grade glycerine solely through its chemical characteristics. They must also evaluate the Certificate of Analysis, European Pharmacopoeia compliance and shelf-life validation. Batch traceability and quality systems also influence supplier qualification.
Spiga Nord addresses these requirements through quality control, risk management and regulatory compliance. The company provides comprehensive technical documentation and updates it as regulatory requirements evolve.
Spiga Nord offers excipient-grade glycerine products for pharmaceutical and nutraceutical applications. The range also supports companies that require excipients aligned with major international standards.
This high-purity vegetable glycerine meets European Pharmacopoeia requirements. Manufacturers can use it in pharmaceutical and nutraceutical applications. Spiga Nord supplies every batch with a complete Certificate of Analysis. The document reports the analytical result for every parameter in the Ph. Eur. monograph.
Customers can also choose the 99.7% grade with Kosher and Halal certifications. This option supports international markets and certified production processes without compromising product quality or regulatory standards.
This grade contains 86.5% glycerol and meets European Pharmacopoeia requirements. It supports applications that require a diluted glycerine solution. Spiga Nord applies the same quality, documentation and traceability standards across its Excipient range.
Spiga Nord provides current technical documentation, product dossiers, specifications and regulatory declarations. The company also conducts stability studies and maintains full batch traceability. Its specialists support customers throughout supplier qualification.
Regulatory compliance forms a central part of Spiga Nord’s pharmaceutical offering. The company supports its excipient-grade glycerine with comprehensive technical documentation and a structured quality system.
Key elements include:
This approach simplifies supplier qualification. It also gives customers the documentation they need for audits, regulatory inspections and validation procedures.
Spiga Nord specialises in vegetable glycerine for pharmaceutical use. The company combines chemical expertise, regulatory experience and industrial reliability. Its team supports customers throughout product selection, supplier qualification and regulatory review.
Spiga Nord’s production facility exclusively refines vegetable glycerine. A structured quality system governs every activity. The in-house laboratory tests raw materials and finished products. Supplier qualification procedures support consistent input quality.
The system also covers continuous improvement, nonconformity management, CAPA procedures and internal audits. Complete segregation protects raw materials and finished products throughout production and storage.
A unique code identifies each batch and connects it to the raw materials used in production. Every shipment includes the documentation required by the pharmaceutical industry. This package can include Certificates of Analysis, Product Dossiers and relevant regulatory declarations.
Spiga Nord conducts stability studies according to EMA guidance. The results support a shelf life of 24 months under proper storage conditions. On request, the company also retests products near the end of their shelf life to confirm continued compliance.
For Spiga Nord, pharmaceutical-grade glycerine represents more than an excipient. It reflects a controlled supply chain, a rigorous quality system and continuous regulatory monitoring.
This approach allows the company to act as a technical and regulatory partner. Spiga Nord provides reliable solutions for pharmaceutical and nutraceutical formulations. Its team helps customers meet demanding quality standards and evolving international requirements.
A highly refined, 100% plant-derived glycerol (≥99.7%) offering triple compliance as an EP pharmaceutical excipient, E422 food additive, and cosmetic ingredient. Extremely versatile and safe, it acts as a premium humectant, binder, and solvent for medicinal syrups, oral treatments, high-quality foods, and advanced dermatological formulations.
Multi-certified vegetable glycerol (≥99.7%) fully compliant with EP pharmaceutical excipient and E422 food additive standards, plus Kosher and Halal certifications. Designed for highly regulated global markets, it ensures maximum microbiological purity and exceptional humectant performance for pharmaceutical, nutritional, and personal care products.
High-purity vegetable glycerol (≥99.7%) specifically developed to serve as a pharmaceutical excipient under European Pharmacopoeia (EP) standards. It is an essential component for medicinal solutions, syrups, topical preparations, and medical-grade cosmetics, guaranteeing maximum chemical-pharmaceutical quality, stability, and microbiological safety.
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.
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.