{"id":2512,"date":"2025-09-22T12:50:25","date_gmt":"2025-09-22T05:50:25","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=2512"},"modified":"2025-09-29T16:44:05","modified_gmt":"2025-09-29T09:44:05","slug":"adapalene-cream","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/adapalene-cream\/","title":{"rendered":"Adapalene Cream"},"content":{"rendered":"

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

Action and use<\/p>\n

Vitamin A analogue (retinoid); treatment of acne.<\/p>\n

DEFINITION<\/h2>\n
Adapalene Cream contains Adapalene in a suitable basis.<\/p>\n
The cream complies with the requirements stated under Topical Semi-solid Preparations and with the following requirements.<\/p>\n
Content of adapalene, C_{28<\/sub>H_{28<\/sub>O_{3<\/sub><\/p>\n}}}
95.0 to 105.0% of the stated amount.<\/p>\n

IDENTIFICATION<\/h2>\n
A. Carry out the method for thin-layer chromatography, Appendix III A, using the following<\/p>\n
\n
Add 10 mL of stabiliser-free tetrahydrofuran to a quantity of cream containing 5 mg of Adapalene and shake to disperse. Add sufficient methanol to produce a solution containing 0.025% w\/v of Adapalene and filter (a 0.2-\u00b5m Dynagard PP filter is suitable).<\/li>\n
025% w\/v of adapalene BPCRS in the mobile phase.<\/li>\n<\/ul>\n
CHROMATOGRAPHIC CONDITIONS<\/p>\n
\n
Use as the coating octadecylsilyl silica gel F254 (Merck silica gel 60 RP-18 F254 plates are suitable).<\/li>\n
Use the mobile phase as described<\/li>\n
Apply 1 \u00b5L of each<\/li>\n
Develop the plate to 15<\/li>\n
After removal of the plate dry in air and examine under ultraviolet light (254 nm).<\/li>\n<\/ul>\n
MOBILE PHASE<\/p>\n
18 volumes of stabiliser-free tetrahydrofuran and 82 volumes of methanol.<\/p>\n
CONFIRMATION<\/p>\n
The principal spot in the chromatogram obtained with solution (1) corresponds in position and colour to that in the chromatogram obtained with solution (2).<\/p>\n
B. In the Assay, the retention time of the principal peak in the chromatogram obtained with solution (1) is similar to that of the principal peak in the chromatogram obtained with solution (2).<\/p>\n
TESTS<\/h2>\n
Acidity<\/h3>\n
pH, 4.5 to 5.5, Appendix V L.<\/p>\n
Related substances<\/h3>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n
Solvent A\u00a0 2 volumes of trifluoroacetic acid and 100 volumes of water.<\/p>\n
Solvent B 10 volumes of solvent A, 25 volumes of acetonitrile, 30 volumes of propan-2-ol and 35 volumes of stabiliser- free tetrahydrofuran.<\/p>\n
\n
To a quantity of the cream containing 1 mg of Adapalene, add 7 mL of stabiliser-free tetrahydrofuran and mix with the aid of ultrasound. Add 6 mL of propan-2-ol, shake, add 2 mL of solvent A and dilute to 20 mL with acetonitrile.<\/li>\n
Dilute 1 volume of solution (1) to 100 volumes with solvent<\/li>\n
005% w\/v of adapalene impurity standard BPCRS in a mixture of equal volumes of stabiliser-free tetrahydrofuran and water<\/span>.<\/span><\/li>\n
Dilute 1 volume of solution (2) to 20 volumes with solvent<\/li>\n<\/ul>\n
CHROMATOGRAPHIC CONDITIONS<\/p>\n
\n
Use a stainless steel column (25 cm \u00d7 4 mm) packed with end-capped octadecylsily l silica gel for chromatography (5 \u00b5m) (LiChrospher 100 RP 18 is suitable).<\/li>\n
Use gradient elution and the mobile phase described<\/li>\n
Use a flow rate of 5 mL per minute.<\/li>\n
Use an ambient column<\/li>\n
Use a fluorimetric detector with the following<\/li>\n<\/ul>\n\n\n\n\n\n
Time (Minutes)<\/td>\n Excitation wavelength (nm)<\/td>\n Emission wavelength (nm)<\/td>\n<\/tr>\n
0-11<\/td>\n 260<\/td>\n 380<\/td>\n<\/tr>\n
11-30<\/td>\n 260<\/td>\n 347<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
\n
Inject 10 \u00b5L of each<\/li>\n<\/ul>\n
MOBILE PHASE<\/p>\n
Mobile phase A 0.2 volume of trifluoroacetic acid and 100 volumes of water.<\/p>\n
Mobile phase B\u00a0 40 volumes stabiliser-free tetrahydrofuran and 60 volumes of acetonitrile.<\/p>\n\n\n\n\n\n\n\n
Time (Minutes)<\/td>\n Mobile phase A (% v\/v)<\/td>\n Mobile phase B (% v\/v)<\/td>\n Comment<\/td>\n<\/tr>\n
0-3<\/td>\n 40-\u00bb17<\/td>\n 60->83<\/td>\n linear gradient<\/td>\n<\/tr>\n
3-30<\/td>\n 17<\/td>\n 83<\/td>\n isocratic<\/td>\n<\/tr>\n
30-31<\/td>\n 17->40<\/td>\n 83->60<\/td>\n linear gradient<\/td>\n<\/tr>\n
31-40<\/td>\n 40<\/td>\n 60<\/td>\n re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
When the chromatograms are recorded under the prescribed conditions the retention times relative to adapalene (retention time about 6.5 minutes) are: impurity A, about 0.5 and impurity D, about 3.1.<\/p>\n
SYSTEM SUITABILITY<\/p>\n
The test is not valid unless the chromatogram obtained with solution (3) resembles the chromatogram provided with adapalene impurity standard BPCRS.<\/p>\n
LIMITS<\/p>\n
In the chromatogram obtained with solution (1):<\/p>\n
the area of any peak due to impurity A or impurity D is not greater than the area of the corresponding peak in the chromatogram obtained with solution (3) (0.5%);<\/p>\n
the area of any other secondary peak is not greater than 0.5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.5%);<\/p>\n
the sum of the impurities is not greater than 1.0%.<\/p>\n
Disregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (4) (0.05%).<\/p>\n
ASSAY<\/h2>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n
Solvent C\u00a0 21 volumes of water, 36 volumes of stabiliser-free tetrahydrofuran and 43 volumes of acetonitrile.<\/p>\n
\n
Disperse a quantity of the cream containing 1 mg of Adapalene in 10 mL of stabiliser-free tetrahydrofuran and shake with the aid of ultrasound for 5 minutes, dilute to 50 mL with solvent C and filter (a 0.2-\u00b5m Dynagard filter is suitable).<\/li>\n
Dilute 1 volume of a 01% w\/v of adapalene BPCRS in stabiliser-free tetrahydrofuran to 5 volumes with solvent C.<\/li>\n<\/ul>\n
CHROMATOGRAPHIC CONDITIONS<\/p>\n
\n
Use a stainless steel column (25 cm \u00d7 4 mm) with a stainless steel pre-column (4 mm \u00d7 4 mm) both packed with end- capped octadecylsily l silica gel for chromatography (5 \u00b5m) (LiChrospher 100 RP 18 is suitable).<\/li>\n
Use isocratic elution and the mobile phase described<\/li>\n
Use a flow rate of 1 mL per<\/li>\n
Use an ambient column<\/li>\n
Use a detection wavelength of 270<\/li>\n
Inject 25 \u00b5L of each<\/li>\n<\/ul>\n
MOBILE PHASE<\/p>\n
0.02 volume of trifluoroacetic acid, 21 volumes of water, 36 volumes of stabiliser-free tetrahydrofuran and 43 volumes of acetonitrile.<\/p>\n
SYSTEM SUITABILITY<\/p>\n
The test is not valid unless, in the chromatogram obtained with solution (2), the column efficiency, determined on the peak due to adapalene, is at least 4500 theoretical plates per metre.<\/p>\n
DETERMINATION OF CONTENT<\/p>\n
Calculate the content of C28H28O3 in the cream using the declared content of C28H28O3 in adapalene BPCRS.<\/p>\n
IMPURITIES<\/h2>\n
The impurities limited by the requirements of this monograph include impurities A and D listed under Adapalene.<\/p>\n","protected":false},"excerpt":{"rendered":"
Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Vitamin A analogue (retinoid); treatment of acne. DEFINITION Adapalene Cream contains Adapalene in a suitable basis. The cream complies with the requirements stated under Topical Semi-solid Preparations and with the following requirements. Content of adapalene, C28H28O3 95.0 to 105.0% of the stated amount. IDENTIFICATION A….<\/p>\n","protected":false},"author":5,"featured_media":2516,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-2512","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-formulated-preparations-specific-monographs"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/2512","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=2512"}],"version-history":[{"count":5,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/2512\/revisions"}],"predecessor-version":[{"id":5841,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/2512\/revisions\/5841"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/2516"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=2512"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=2512"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=2512"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

TESTS<\/h2>\n

Acidity<\/h3>\npH, 4.5 to 5.5, Appendix V L.<\/p>\n

Acidity<\/h3>\n
pH, 4.5 to 5.5, Appendix V L.<\/p>\n