Stearic Acid
Stearic Acid is a versatile and essential fatty acid widely used in various industries, including pharmaceuticals. It is a saturated fatty acid derived from natural sources like palm and coconut oils. STACLUB is 100% vegetable origin, NOT animal derived.
In its solid form, it appears as a white, waxy substance and is known for its stability and remarkable chemical properties. Our pharmaceutical-grade Stearic Acid meets the highest quality standards, ensuring it is free from impurities and contaminants.
Application in Pharmaceuticals:
- Tablet Binders
- Controlled Release Formulations
- Emulsifier and Stabilizer
- Solubility Enhancement
Why Choose Us?
- Operating an FDA-approved in-house laboratory with routine external testing for verified results.
- Supplying various grades | Specification customization available.
- Consistent excellence in product quality.
- A proficient team of engineers and a dedicated sales force, ensuring after-sales support service.
Staclub – Stearic Acid | IP/BP/USP
Test | Specification |
Description/ Appearance | 1.A white powder or white, greasy, flaky crystals, or hard masses showing signs of crystallisation as IP. 2.White or almost white, waxy, flaky crystals, white or almost white hard masses, or white or yellowish-white powder as BP/USP. |
Solubility | 1.Soluble in chloroform, in ethanol and in ether; practically insoluble in water as IP. 2.Practically insoluble in water, soluble in ethanol (96%) and in light petroleum (50-70°C) as BP/USP. |
Identification (Assay) | The chromatogram obtained with the test solution shows two principal peaks which correspond to the two principle peaks in the chromatogram obtained with reference solution (C) as IP. |
Identification Test – A(Freezing Point) | 640C – 690C as BP/USP |
Identification Test – B (Acid value) | 194 to 212 as BP/USP |
Congealing temperature | NLT 54°C as IP |
Acid value | 200 to 212 as IP |
Iodine value | NMT 4.0 as IP |
Mineral acid | No red colour is produced as IP |
Heavy metals | NMT 20 ppm as IP |
Sulphated ash/ Residue on ignition | NMT 0.1% as IP/USP |
Assay | NLT 40.0 % of steric acid (C18H36O2), stearic acid (C18H36O2) and palmitic acid (C16H32O2) is NLT 90.0% as IP NLT 90.0% of stearic acid (C18H36O2), and the sum of the stearic acid and palmitic acid is NLT 96.0% as BP/USP. |
Appearance/ Colour of solution | The resulting liquid is not more intensely coloured than reference solution Y7 or BY7 as BP/USP |
Acidity | No red colour develops as BP/USP |
Iodine value | NMT 1.5 as BP |
Freezing Point | 640C – 690C as BP |
Fats and fixed oils | NMT 1.5 as USP |
Microbiological Analysis
Total Aerobic Microbial Count, CFU/g | NMT 1000 |
Total Combined Yeasts & Molds Count, CFU/g | NMT 500 |
Staphylococcus aureus, / g | Should be absent |
Pseudomonas aeruginosa, / g | Should be absent |
Escherichia coli, / g | Should be absent |
Salmonella, /10g | Should be absent |