Hard fat, also known as Adeps Solidus, is a pharmaceutical ingredient used primarily as a base in suppositories and ointments. It is derived from animal fats and consists primarily of triglycerides, which contribute to its solid consistency at room temperature. Here's a detailed product description from a pharmaceutical perspective:
Composition: Hard fat is composed predominantly of saturated fatty acids, typically with a melting point ranging from 33°C to 36°C (91.4°F to 96.8°F). It is solid at room temperature and becomes liquid when heated slightly above its melting point.
Usage:
Suppositories: Hard fat serves as an ideal base for suppositories due to its ability to melt at body temperature, ensuring easy insertion and gradual release of the active pharmaceutical ingredient.
Ointments: It is used in topical ointments and creams as an emollient and vehicle for delivering medicinal substances to the skin.
Properties:
Emulsifying Agent: Hard fat acts as an emulsifier, facilitating the incorporation of water-soluble drugs into hydrophobic formulations.
Stability: It provides stability to formulations by protecting active ingredients from degradation and enhancing shelf life.
Manufacturing Standards: Hard fat is manufactured under strict pharmaceutical guidelines to ensure purity, consistency, and safety. It complies with pharmacopeial standards such as the European Pharmacopoeia or United States Pharmacopeia.
Benefits:
Biocompatibility: Being of animal origin, hard fat is well-tolerated by the human body, minimizing the risk of allergic reactions.
Versatility: Its ability to blend with a wide range of active ingredients makes it suitable for various pharmaceutical applications.
Conclusion: Hard fat (Adeps Solidus) is a vital component in pharmaceutical formulations, prized for its stability, biocompatibility, and versatile applications in suppositories and topical preparations. Its use ensures effective delivery of medicinal substances while enhancing patient comfort and compliance.
Itens | Specifications | Results |
---|---|---|
Appearance | White, brittle mass. | Conforms |
Identification | Complies | Conforns |
Melting point | 33~35 ℃ | 34 |
Acid value | <0.5 mgKOH/g | 0.2 |
Hydroxyl value | 5-15 mgKOH/g | 8 |
iodine value | <2.0 gl/100g | 0.1 |
Peroxide value | <3.0 meq0./kg | 0.3 |
Saponification value | 230-245 mgKOH/g | 242 |
Unsaponifiable matter | ≤ 0.6 % | 0.1 |
Alkaline impurities | ≤ 0.15 ml | Conforms |
Ash | <0.05% | 0.01 |
Water content | ≤0.15 % | 0.05 |
Heavy metal | ≤10 ppm | Conforms |
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