Tiêu đề Calcium Stearate - British Pharmacopoeia.pdf ✅

Quality standards Edition: BP 2025 (Ph. Eur. 11.6 update) General Notices (Ph. Eur. monograph 0882) 1592-23-0 Action and use Excipient. Ph Eur DEFINITION Mixture of calcium salts of different fatty acids consisting mainly of stearic (octadecanoic) acid [(C17H35COO)2Ca; Mr 607] and palmitic (hexadecanoic) acid [(C15H31COO)2Ca; Mr 550.9] with minor proportions of other fatty acids. Content — calcium: 6.4 per cent to 7.4 per cent (Ar 40.08) (dried substance); — stearic acid in the fatty acid fraction: minimum 40.0 per cent; — sum of stearic acid and palmitic acid in the fatty acid fraction: minimum 90.0 per cent. CHARACTERS Appearance Fine, white or almost white, crystalline powder. Solubility Practically insoluble in water and in ethanol (96 per cent). IDENTIFICATION First identification: C, D. Second identification: A, B, D. A. Freezing point (2.2.18): minimum 53 °C, for the residue obtained in the preparation of solution S (see Tests). B. Acid value (2.5.1): 195 to 210. Dissolve 0.200 g of the residue obtained in the preparation of solution S in 25 mL of the prescribed mixture of solvents. Calcium Stearate www.webofpharma.com

15 mg of mordant black 11 triturate R. Heat to 45-50 °C until the solution is clear. Cool and titrate with 0.1 M zinc sulfate until the colour changes from blue to violet. Carry out a blank titration. 1 mL of 0.1 M sodium edetate is equivalent to 4.008 mg of Ca. Composition of fatty acids Gas chromatography (2.2.28): use the normalisation procedure. Test solution In a conical flask fitted with a reflux condenser, dissolve 0.10 g of the substance to be examined in 5 mL of boron trifluoride-methanol solution R. Boil under a reflux condenser for 10 min. Add 4 mL of heptane R through the condenser. Boil under a reflux condenser for 10 min. Allow to cool. Add 20 mL of saturated sodium chloride solution R. Shake and allow the layers to separate. Remove about 2 mL of the organic layer and dry over 0.2 g of anhydrous sodium sulfate R. Dilute 1.0 mL of the solution to 10.0 mL with heptane R. Reference solution Prepare the reference solution in the same manner as the test solution using 50.0 mg of palmitic acid CRS and 50.0 mg of stearic acid CRS instead of calcium stearate. Column: — material: fused silica; — size: l = 30 m, Ø = 0.32 mm; — stationary phase: macrogol 20 000 R (film thickness 0.5 μm). Carrier gas helium for chromatography R. Flow rate 2.4 mL/min. Temperature: Time (min) Temperature (°C) Column 0 - 2 70 2 - 36 70 → 240 36 - 41 240 Injection port 220 Detector 260 Detection Flame ionisation. Injection 1 μL. Relative retention With reference to methyl stearate: methyl palmitate = about 0.9. System suitability Reference solution: — resolution: minimum 5.0 between the peaks due to methyl palmitate and methyl stearate. Calculate the content of palmitic acid and stearic acid. FUNCTIONALITY-RELATED CHARACTERISTICS This section provides information on characteristics that are recognised as being relevant control parameters for one or more functions of the substance when used as an excipient (see chapter 5.15). Some of the characteristics described in the Functionality-related characteristics section may also be present in the mandatory part of the monograph since they also represent mandatory quality criteria. In such cases, a cross-reference to the tests described in the mandatory part is included in the Functionality-related characteristics section. Control of the characteristics can contribute to the quality of a medicinal product by improving the consistency of the manufacturing process and the performance of the medicinal product during use. Where control methods are cited, they are recognised as being suitable for the purpose, but other methods can also be used. Wherever results for a particular characteristic are reported, the control method must be indicated. www.webofpharma.com