{"id":29275,"date":"2025-11-10T15:34:22","date_gmt":"2025-11-10T08:34:22","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=29275"},"modified":"2025-11-10T15:34:22","modified_gmt":"2025-11-10T08:34:22","slug":"refined-castor-oil","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/refined-castor-oil\/","title":{"rendered":"Refined Castor Oil"},"content":{"rendered":"

Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n

DEFINITION<\/h2>\n
Fatty oil obtained from the seeds of Ricinus communis L. by cold expression. It is then refined. A suitable antioxidant may be added.<\/p>\n

PRODUCTION<\/h2>\n
During the expression step, the temperature of the oil must not exceed 50 \u00b0C.<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\n
Clear, almost colourless or slightly yellow, viscous, hygroscopic liquid.<\/p>\n

Solubility<\/h3>\n
Slightly soluble in light petroleum, miscible with ethanol (96 per cent) and with glacial acetic acid.<\/p>\n

Relative density<\/h3>\n
About 0.958.<\/p>\n

Refractive index<\/h3>\n
About 1.479.<\/p>\n

Viscosity<\/h3>\n
About 1000 mPa\u00b7s.<\/p>\n

IDENTIFICATION<\/h2>\n
First identification: B, C.<\/em><\/p>\n
Second identification: A, B.<\/em><\/p>\n
A. A mixture of 2 mL of the substance to be examined and 8 mL of ethanol (96 per cent) R is clear (2.2.1).<\/p>\n
B. Specific absorbance (see Tests).<\/p>\n
C. Composition of fatty acids (see Tests).<\/p>\n

TESTS<\/h2>\n
Appearance<\/h3>\n
The substance to be examined is clear (2.2.1) and not more intensely coloured than reference solution BY3 or Y3 (2.2.2, Method I).<\/p>\n
Optical rotation (2.2.7)<\/strong><\/p>\n
+ 3.5\u00b0 to + 6.0\u00b0.<\/p>\n
Specific absorbance (2.2.25)<\/strong><\/p>\n
0.7 to 1.5, determined at the absorption maximum at 270 nm.<\/p>\n
To 1.00 g add ethanol (96 per cent) R and dilute to 100.0 mL with the same solvent.<\/p>\n
Acid value (2.5.1)<\/strong><\/p>\n
Maximum 0.8.<\/p>\n
Dissolve 5.00 g in 25 mL of the prescribed mixture of solvents.<\/p>\n
Hydroxyl value (2.5.3, Method A)<\/strong> Minimum 160.<\/p>\n
Peroxide value (2.5.5, Method A)<\/strong> Maximum 5.0.<\/p>\n
Unsaponifiable matter (2.5.7)<\/strong><\/p>\n
Maximum 0.8 per cent, determined on 5.0 g.<\/p>\n
Oil obtained by extraction and adulteration<\/h3>\n
In a ground-glass-stoppered tube about 125 mm long and 18 mm in internal diameter, thoroughly mix 3 mL of the substance to be examined with 3 mL of carbon disulfide R. Shake for 3 min with 1 mL of sulfuric acid R. The mixture is less intensely coloured than a freshly prepared mixture of 3.2 mL of ferric chloride solution R1,<\/p>\n
2.3 mL of water R and 0.5 mL of dilute ammonia R1.<\/p>\n
Composition of fatty acids<\/h3>\n
Gas chromatography (2.4.22) with the following modifications. Use the mixture of calibrating substances in Table 2.4.22.-3.<\/p>\n
Test solution Introduce 75 mg of the substance to be examined into a 10 mL centrifuge tube with a screw cap. Dissolve in 2 mL of 1,1-dimethylethyl methyl ether R1 with shaking and heat gently (50-60 \u00b0C). Add, while still warm, 1 mL of a 12 g\/L solution of sodium R in anhydrous methanol R, prepared with the necessary precautions, and shake vigorously for at least 5 min. Add 5 mL of distilled water R and shake vigorously for about 30 s. Centrifuge for 15 min at 1500 g. Use the upper layer.<\/p>\n
Reference solution Dissolve 50 mg of methyl ricinoleate CRS and 50 mg of methyl stearate CRS in 10.0 mL of 1,1- dimethylethyl methyl ether R1.<\/p>\n
Column:<\/p>\n
\u2014 material: fused silica;<\/p>\n
\u2014 size: l = 30 m, \u00d8 = 0.25 mm;<\/p>\n
\u2014 stationary phase: macrogol 20 000 R (film thickness 0.25 \u00b5m).<\/p>\n
Carrier gas helium for chromatography R. Flow rate 0.9 mL\/min.<\/p>\n
Split ratio\u00a0 1:100.<\/p>\n
Temperature:<\/p>\n\n\n\n\n\n\n
<\/td>\n Time (min)<\/strong><\/td>\n Temperature (\u00b0C)<\/strong><\/td>\n<\/tr>\n
Column<\/td>\n 0 – 55<\/td>\n 215<\/td>\n<\/tr>\n
Injection port<\/td>\n 250<\/td>\n<\/tr>\n
Detector<\/td>\n 250<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
Detection\u00a0 Flame ionisation.<\/p>\n
Injection\u00a0 1 \u00b5L.<\/p>\n
System suitability:<\/p>\n
\u2014 symmetry factor: 0.7 to 1.5 for the peak due to methyl stearate in the chromatogram obtained with the test solution.<\/p>\n
Calculate the percentage content of each fatty acid by the normalisation procedure.<\/p>\n
Correct the area of the peak due to methyl ricinoleate, by multiplying by a factor R calculated using the following expression:<\/p>\n
(m_{1<\/sub>\u00d7A_{2<\/sub>)\/(A_{1<\/sub>\u00d7m_{2<\/sub>)<\/p>\n}}}}
m_{1<\/sub> = mass of methyl ricinoleate in the reference solution;<\/p>\n}
m_{2<\/sub> = mass of methyl stearate in the reference solution;<\/p>\n}
A_{1<\/sub> = area of the peak due to methyl ricinoleate in the chromatogram obtained with the reference solution;<\/p>\n}
A_{2<\/sub> = area of the peak due to methyl stearate in the chromatogram obtained with the reference solution.<\/p>\n}
Composition of the fatty-acid fraction of the oil:<\/p>\n
\u2014 palmitic acid: maximum 2.0 per cent;<\/p>\n
\u2014 stearic acid: maximum 2.5 per cent;<\/p>\n
\u2014 oleic acid and isomer: 2.5 per cent to 6.0 per cent;<\/p>\n
\u2014 linoleic acid: 2.5 per cent to 7.0 per cent;<\/p>\n
\u2014 linolenic acid: maximum 1.0 per cent;<\/p>\n
\u2014 eicosenoic acid: maximum 1.0 per cent;<\/p>\n
\u2014 ricinoleic acid: 85.0 per cent to 92.0 per cent;<\/p>\n
\u2014 any other fatty acid: for each fatty acid, maximum 1.0 per cent.<\/p>\n
Water (2.5.32)<\/strong><\/p>\n
Maximum 0.3 per cent, or maximum 0.2 per cent if intended for use in the manufacture of parenteral preparations, determined on 1.00 g.<\/p>\n
STORAGE<\/h2>\n
In an airtight, well-filled container, protected from light. If intended for use in the manufacture of parenteral preparations, store under an inert gas.<\/p>\n
LABELLING<\/h2>\n
The label states, where applicable, that the substance is suitable for use in the manufacture of parenteral preparations and the name of the inert gas.<\/p>\n","protected":false},"excerpt":{"rendered":"
Edition: BP 2025 (Ph. Eur. 11.6 update) DEFINITION Fatty oil obtained from the seeds of Ricinus communis L. by cold expression. It is then refined. A suitable antioxidant may be added. PRODUCTION During the expression step, the temperature of the oil must not exceed 50 \u00b0C. CHARACTERS Appearance Clear, almost colourless or slightly yellow, viscous,…<\/p>\n","protected":false},"author":5,"featured_media":29276,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-29275","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicinal-substances"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/29275","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=29275"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/29275\/revisions"}],"predecessor-version":[{"id":29279,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/29275\/revisions\/29279"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/29276"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=29275"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=29275"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=29275"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

<\/td>\n	Time (min)<\/strong><\/td>\n	Temperature (\u00b0C)<\/strong><\/td>\n<\/tr>\n
Column<\/td>\n	0 – 55<\/td>\n	215<\/td>\n<\/tr>\n
Injection port<\/td>\n	250<\/td>\n<\/tr>\n
Detector<\/td>\n	250<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Detection\u00a0 Flame ionisation.<\/p>\n Injection\u00a0 1 \u00b5L.<\/p>\n System suitability:<\/p>\n \u2014 symmetry factor: 0.7 to 1.5 for the peak due to methyl stearate in the chromatogram obtained with the test solution.<\/p>\n Calculate the percentage content of each fatty acid by the normalisation procedure.<\/p>\n Correct the area of the peak due to methyl ricinoleate, by multiplying by a factor R calculated using the following expression:<\/p>\n (m_{1<\/sub>\u00d7A_{2<\/sub>)\/(A_{1<\/sub>\u00d7m_{2<\/sub>)<\/p>\n}}}} m_{1<\/sub> = mass of methyl ricinoleate in the reference solution;<\/p>\n} m_{2<\/sub> = mass of methyl stearate in the reference solution;<\/p>\n} A_{1<\/sub> = area of the peak due to methyl ricinoleate in the chromatogram obtained with the reference solution;<\/p>\n} A_{2<\/sub> = area of the peak due to methyl stearate in the chromatogram obtained with the reference solution.<\/p>\n} Composition of the fatty-acid fraction of the oil:<\/p>\n \u2014 palmitic acid: maximum 2.0 per cent;<\/p>\n \u2014 stearic acid: maximum 2.5 per cent;<\/p>\n \u2014 oleic acid and isomer: 2.5 per cent to 6.0 per cent;<\/p>\n \u2014 linoleic acid: 2.5 per cent to 7.0 per cent;<\/p>\n \u2014 linolenic acid: maximum 1.0 per cent;<\/p>\n \u2014 eicosenoic acid: maximum 1.0 per cent;<\/p>\n \u2014 ricinoleic acid: 85.0 per cent to 92.0 per cent;<\/p>\n \u2014 any other fatty acid: for each fatty acid, maximum 1.0 per cent.<\/p>\n Water (2.5.32)<\/strong><\/p>\n Maximum 0.3 per cent, or maximum 0.2 per cent if intended for use in the manufacture of parenteral preparations, determined on 1.00 g.<\/p>\n STORAGE<\/h2>\n In an airtight, well-filled container, protected from light. If intended for use in the manufacture of parenteral preparations, store under an inert gas.<\/p>\n LABELLING<\/h2>\n The label states, where applicable, that the substance is suitable for use in the manufacture of parenteral preparations and the name of the inert gas.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) DEFINITION Fatty oil obtained from the seeds of Ricinus communis L. by cold expression. It is then refined. A suitable antioxidant may be added. PRODUCTION During the expression step, the temperature of the oil must not exceed 50 \u00b0C. CHARACTERS Appearance Clear, almost colourless or slightly yellow, viscous,…<\/p>\n","protected":false},"author":5,"featured_media":29276,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-29275","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicinal-substances"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/29275","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=29275"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/29275\/revisions"}],"predecessor-version":[{"id":29279,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/29275\/revisions\/29279"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/29276"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=29275"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=29275"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=29275"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

DEFINITION<\/h2>\nFatty oil obtained from the seeds of Ricinus communis L. by cold expression. It is then refined. A suitable antioxidant may be added.<\/p>\n

PRODUCTION<\/h2>\nDuring the expression step, the temperature of the oil must not exceed 50 \u00b0C.<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\nClear, almost colourless or slightly yellow, viscous, hygroscopic liquid.<\/p>\n

Solubility<\/h3>\nSlightly soluble in light petroleum, miscible with ethanol (96 per cent) and with glacial acetic acid.<\/p>\n

Relative density<\/h3>\nAbout 0.958.<\/p>\n

Refractive index<\/h3>\nAbout 1.479.<\/p>\n