Hard Fat — China Manufacturer | Pharma-Grade Excipient R&D to Production

Product Overview & China Production Capacity

Hard Fat (Adeps Solidus, ) is a mixture of mono-, di-, and triglycerides of saturated C10–C18 fatty acids, primarily used as a suppository base and lipophilic carrier in pharmaceutical manufacturing. With controlled melting points ranging from 33–36°C (depending on grade), hard fat melts readily at body temperature to release incorporated active ingredients. It is the preferred suppository base worldwide due to its excellent mold release properties, chemical inertness, and compatibility with most APIs. It also serves as a lipid vehicle in semi-solid formulations, pellet coatings, and lipid-based drug delivery systems.

China’s hard fat production capacity has grown significantly, with multiple production facilities now producing pharmaceutical-grade material totaling over 15,000 MT annual capacity. Our oleochemical facility in Jiangsu Province produces 5,000 MT/year of pharmaceutical-grade hard fat through controlled hydrogenation and interesterification of palm kernel oil fractions, offering multiple melting point grades to suit diverse formulation requirements.

Manufacturing Standards & Quality Assurance

Manufacturing operates under pharmaceutical quality controls with ISO 9001:2015 certification. The product meets EP (Adeps Solidus), USP/NF (Hard Fat), and ChP monograph specifications. Our interesterification process uses food-grade catalysts with complete removal in the finished product, and all raw materials are vegetable-derived from certified sustainable palm sources.

Quality control includes acid value, hydroxyl value, iodine value, saponification value, peroxide value, melting range (capillary method and DSC), unsaponifiable matter, fatty acid composition (GC), nickel residue, heavy metals, and microbial limits. Each grade is characterized by its solidification and melting behavior to ensure reliable suppository filling performance.

Technical Specifications

ParameterSpecification
AppearanceWhite to yellowish-white waxy solid
Acid Value≤0.5 mg KOH/g
Hydroxyl Value5–50 mg KOH/g (grade dependent)
Iodine Value≤3.0 g I₂/100g
Saponification Value210–260 mg KOH/g
Peroxide Value≤3.0 meq O₂/kg
Melting Range33.0–36.0°C (standard grade)
Unsaponifiable Matter≤0.6%
Nickel (Ni)≤1 ppm
Heavy Metals (as Pb)≤10 ppm

Packaging & Export Logistics

Supplied in 25 kg cardboard cartons with PE-coated inner liner (block or flake form). 200 kg drums available for larger orders. Temperature-sensitive product — store at 15–25°C, protected from heat and direct sunlight. Shelf life is 24 months under recommended storage conditions. Non-hazardous for transport but requires temperature management during summer shipping.

We ship from Shanghai and Nanjing ports. Temperature-controlled container options are available for shipments to tropical destinations. Documentation includes COA, MSDS, RSPO certification, and vegetable-origin declaration.

China Supply Advantage

Sourcing pharmaceutical-grade hard fat from our China facility delivers 35–50% cost savings versus established European suppository base manufacturers. Our proximity to Southeast Asian palm kernel oil sources and integrated oleochemical processing capability provide raw material security and competitive production economics.

MOQ is 500 kg with production lead times of 14–21 business days for standard melting point grades. We offer grades spanning 30–44°C melting range to match specific suppository and lipid formulation requirements. Technical support includes mold compatibility testing and suppository filling parameter optimization. Contact us for product grade selection and pricing.

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