Description

Kolliphor HS 15

Kolliphor HS 15 is a nonionic pharmaceutical solubilizer and emulsifying excipient used in oral, topical, and parenteral formulation development where improved solubilization, dispersion, emulsification, and formulation consistency are required. It is identified as a pharmaceutical excipient composed primarily of polyglycol mono- and di-esters of 12-hydroxystearic acid together with free polyethylene glycol. It is associated with CAS Registry Number 70142-34-6. It is
• A nonionic pharmaceutical solubilizer and emulsifier
• Suitable for oral, topical, and parenteral formulation development
• Hydrophilic-lipophilic balance (HLB) of approximately 14–16
• Yellowish-white paste at room temperature that becomes liquid at approximately 30 °C
• Soluble in water, ethanol, and 2-propanol, forming clear solutions
• Supported by technical and safety documentation for pharmaceutical excipient qualification
Kolliphor HS 15 is used in pharmaceutical formulation programs where the aqueous solubility or dispersion of active ingredients creates development challenges. It is for applications involving solubilization, emulsification, co-emulsification, and surfactant functionality across oral, topical, and parenteral dosage forms. These characteristics make Kolliphor HS 15 relevant to development programs involving poorly water-soluble active pharmaceutical ingredients, lipid-based delivery systems, emulsions, solutions, and other formulations where improved drug dispersion or solubilization is required.
The material has amphiphilic properties derived from its combination of lipophilic 12-hydroxystearic acid components and hydrophilic polyethylene glycol chains. Kolliphor HS 15 has an HLB value between 14 and 16. At room temperature it is a yellowish-white paste and becomes liquid at approximately 30 °C. It dissolves in water, ethanol, and 2-propanol to form clear solutions, while its water solubility decreases as temperature increases. The material is insoluble in liquid paraffin. These characteristics should be considered during heating, mixing, dissolution, transfer, filtration, and scale-up operations.
For companies looking to buy Kolliphor HS 15, supplier qualification should involve more than immediate price and availability. A qualified Kolliphor HS 15 supplier should provide clear information regarding identity, composition, hydroxyl value, saponification value, water content, acidity, peroxide-related controls where applicable, physical appearance, storage requirements, and other grade-specific specifications. Because Kolliphor HS 15 is a complex excipient mixture rather than a single discrete molecular compound, evaluation should focus on the complete material specification and functional characteristics rather than a single molecular formula.
CarboMer approaches Kolliphor HS 15 sourcing with a regulation-first and formulation-centered perspective. Research and development teams benefit from a supplier that can support solubility screening, excipient compatibility studies, emulsion development, formulation optimization, and scale-up planning. Quality and regulatory professionals require traceable lot documentation and clearly defined specifications. Procurement teams need confidence that the selected material can be purchased consistently as a program progresses from early formulation work to validation and commercial manufacturing.
When customers purchase Kolliphor HS 15 for pharmaceutical development, the selected material should be evaluated within the context of the intended dosage form and route of administration. The U.S. Food and Drug Administration maintains an Inactive Ingredient Database that identifies excipients used in approved drug products by route and dosage form; inclusion of an excipient in that database is useful regulatory context but does not by itself establish suitability for every formulation, concentration, or new drug application.
Kolliphor HS 15 is not for sale to or use by the general public. Customers should therefore evaluate the material within qualified pharmaceutical, research, or manufacturing programs and confirm the applicable regulatory, compendial, and quality requirements for the proposed use.
The material is supported by standard technical documentation, including a Certificate of Analysis, Safety Data Sheet, and related product information where applicable. Available analytical specifications, storage conditions, retest periods, compendial alignment, and regulatory documentation should be confirmed for the individual supplied grade before purchase. Batch-to-batch consistency, traceability, and controlled storage remain central to reliable excipient sourcing and downstream formulation performance.
Kolliphor HS 15 should be handled according to the current Safety Data Sheet and site-specific procedures. Because the material changes physical state near typical room and processing temperatures, appropriate temperature control should be considered during sampling, weighing, transfer, and manufacturing operations. Containers should be maintained under the storage conditions specified by the manufacturer and protected from contamination and conditions that could alter material quality.
The material is packaged in suitable containers selected to protect product quality during storage, handling, and transportation. Packaging formats, minimum order quantities, availability, and lead times may be discussed according to formulation-development, validation, and commercial purchasing requirements.
As with all CarboMer products, customers receive responsive technical communication and documentation support intended to advance excipient qualification, formulation optimization, scale-up, and long-term supply planning.