Pharmacopeial Specifications
| Test | JP | PhEur | USPNF |
|---|---|---|---|
| Acidity | – | ✔ | – |
| Acid value | 194–210 | 194–212 | – |
| Appearance | – | ✔ | – |
| Characters | – | ✔ | – |
| Stearic acid content | – | 50: 40–60% 70: 60–80% 95: ≥90% |
≥40% |
| Stearic + Palmitic acids | – | ≥90% | ≥90% |
| Congealing temp. (°C) | 56.0–72.0 | – | ≥54 |
| Freezing point (°C) | ✔ | 50: 53–59 70: 57–64 95: 64–69 |
– |
| Iodine value | ≤4.0 | ✔ | ≤4.0 |
| Nickel | – | ≤1 ppm | – |
| Residue on ignition | ≤0.1% | – | ≤0.1% |
| Heavy metals | ≤20 ppm | – | ≤0.001% |
| Neutral fat/paraffin | ✔ | – | ✔ |
| Mineral acid | ✔ | – | ✔ |
| Org. volatile impurities | – | – | ✔ |
Applications in Pharmaceutical Formulation or Technology
Used in oral formulations as a lubricant (1–3%) and binder. In topical forms, it acts as an emulsifying and solubilizing agent. When neutralized with alkalis or triethanolamine, it forms cream bases. Also used as a hardening agent in glycerin suppositories and widely used in cosmetics and food.
Comment
Various commercial grades exist with different physical properties based on stearic/palmitic acid ratio. The EINECS number is 200-313-4. The USPNF has separate monographs for standard and purified grades.
