{"id":22878,"date":"2025-10-30T17:31:08","date_gmt":"2025-10-30T10:31:08","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=22878"},"modified":"2025-10-30T17:31:08","modified_gmt":"2025-10-30T10:31:08","slug":"clindamycin-tablets","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/clindamycin-tablets\/","title":{"rendered":"Clindamycin Tablets"},"content":{"rendered":"

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

Action and use<\/strong><\/p>\n

Lincosamide antibacterial.<\/p>\n

DEFINITION<\/h2>\n
Clindamycin Tablets contain Clindamycin Hydrochloride.<\/p>\n
The tablets comply with the requirements stated under Tablets and with the following requirements.<\/em><\/p>\n
Content of clindamycin, C_{18<\/sub>H_{33<\/sub>ClN_{2<\/sub>O_{5<\/sub>S<\/strong><\/p>\n}}}}
95.0 to 105.0% of the stated amount.<\/p>\n
IDENTIFICATION<\/h2>\n
Shake a quantity of the powdered tablets containing the equivalent of 30 mg of clindamycin with 50 mL of dichloromethane, filter and evaporate the filtrate to dryness. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of clindamycin hydrochloride\u00a0 (RS 064).<\/p>\n
TESTS<\/h2>\n
Dissolution<\/h3>\n
Comply with the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n
TEST CONDITIONS<\/h4>\n
(a) Use Apparatus 1, rotating the basket at 100 revolutions per minute.<\/p>\n
(b) Use 900 mL of a solution containing 0.68% w\/v of potassium dihydrogen phosphate and 0.063% w\/v of sodium hydroxide at a temperature of 37\u00b0 as the medium.<\/p>\n
PROCEDURE<\/h4>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n
(1) After 30 minutes withdraw a sample of the medium and filter. Use the filtered sample, diluted with the dissolution medium if necessary, to produce a solution expected to contain 0.0028% w\/v of clindamycin.<\/p>\n
(2) 0.003% w\/v of clindamycin hydrochloride EPCRS in the dissolution medium.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
(a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 \u00b5m) (Hypersil BDS 5 \u00b5m is suitable).<\/p>\n
(b) Use isocratic elution and the mobile phase described below.<\/p>\n
(c) Use a flow rate of 1 mL per minute.<\/p>\n
(d) Use an ambient column temperature.<\/p>\n
(e) Use a detection wavelength of 210 nm.<\/p>\n
(f) Inject 20 \u00b5L of each solution.<\/p>\n
MOBILE PHASE<\/h4>\n
45 volumes of acetonitrile R1 and 55 volumes of a 0.68% w\/v solution of potassium dihydrogen orthophosphate adjusted to pH 7.5 with a 25% w\/v solution of potassium hydroxide.<\/p>\n
When the chromatograms are recorded under the prescribed conditions, the retention time of clindamycin is about 10 minutes.<\/p>\n
DETERMINATION OF CONTENT<\/h4>\n
Calculate the total content of clindamycin, C_{18<\/sub>H_{33<\/sub>ClN_{2<\/sub>O_{5<\/sub>S in the medium from the chromatograms obtained and using the declared content of C_{18<\/sub>H_{33<\/sub>ClN_{2<\/sub>O_{5<\/sub>S,HCl in clindamycin hydrochloride EPCRS. Each mg of C_{18<\/sub>H_{33<\/sub>ClN_{2<\/sub>O_{5<\/sub>S,HCl is equivalent to 0.9209 mg of C_{18<\/sub>H_{33<\/sub>ClN_{2<\/sub>O_{5<\/sub>S.<\/p>\n}}}}}}}}}}}}}}}}
LIMITS<\/h4>\n
The amount of clindamycin released is not less than 80% (Q) of the stated amount.<\/p>\n
Related substances<\/h3>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n
(1) Shake a quantity of the powdered tablets containing the equivalent of 0.1 g of clindamycin with 100 mL of the mobile phase for 15 minutes and filter (Whatman GF\/C filter is suitable).<\/p>\n
(2) Dilute 1 volume of solution (1) to 50 volumes with the mobile phase.<\/p>\n
(3) 0.1% w\/v of clindamycin hydrochloride EPCRS in the mobile phase.<\/p>\n
(4) Dilute 1 volume of solution (2) to 20 volumes with the mobile phase.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
The chromatographic conditions described under Dissolution may be used. For solution (1), allow the chromatography to proceed for at least twice the retention time of the principal peak.<\/p>\n
When the chromatograms are recorded under the prescribed conditions, the relative retentions with reference to clindamycin (retention time, about 10 minutes) are: impurity B, about 0.7 and impurity C, about 0.8.<\/p>\n
SYSTEM SUITABILITY<\/h4>\n
The test is not valid unless, in the chromatogram obtained with solution (3):<\/p>\n
the resolution between the peaks due to impurity B and impurity C is at least 3.0 and; the resolution between the peaks due to impurity C and clindamycin is at least 2.0.<\/p>\n
LIMITS<\/h4>\n
In the chromatogram obtained with solution (1):<\/p>\n
the area of any peak corresponding to impurity C is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (4%);<\/p>\n
the area of any peak corresponding to impurity B is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (2%);<\/p>\n
the area of any other secondary peak is not greater than half the area of the principal peak in the chromatogram obtained with solution (2) (1%);<\/p>\n
the sum of the areas of all the secondary peaks is not greater than 3 times the area of the principal peak in the chromatogram obtained with solution (2) (6%).<\/p>\n
Disregard any peak with an area less than 3 times the area of the principal peak in the chromatogram obtained with solution (4) (0.3%).<\/p>\n
Water<\/h3>\n
The tablets contain not more than 6.0% w\/w, Appendix IX C. Use 0.1 g.<\/p>\n
ASSAY<\/h2>\n
Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n
(1) Shake a quantity of the powdered tablets containing the equivalent of 0.2 g of clindamycin in 160 mL of the mobile phase for 15 minutes, dilute to 200 mL and filter (Whatman GF\/C filter is suitable).<\/p>\n
(2) 0.11% w\/v of clindamycin hydrochloride EPCRS in the mobile phase.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
The chromatographic conditions described under Dissolution may be used.<\/p>\n
DETERMINATION OF CONTENT<\/h3>\n
Calculate the content of C_{18<\/sub>H_{33<\/sub>ClN_{2<\/sub>O_{5<\/sub>S in the tablets using the declared content of C_{18<\/sub>H_{33<\/sub>ClN_{2<\/sub>O_{5<\/sub>S,HCl in clindamycin hydrochloride EPCRS. Each mg of C_{18<\/sub>H_{33<\/sub>ClN_{2<\/sub>O_{5<\/sub>S,HCl is equivalent to 0.9209 mg of C_{18<\/sub>H_{33<\/sub>ClN_{2<\/sub>O_{5<\/sub>S.<\/p>\n}}}}}}}}}}}}}}}}
LABELLING<\/h2>\n
The quantity of active ingredient is stated in terms of the equivalent amount of clindamycin.<\/p>\n
IMPURITIES<\/h2>\n
The impurities limited by the requirements of this monograph include those listed under Clindamycin Hydrochloride.<\/p>\n","protected":false},"excerpt":{"rendered":"
Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Lincosamide antibacterial. DEFINITION Clindamycin Tablets contain Clindamycin Hydrochloride. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of clindamycin, C18H33ClN2O5S 95.0 to 105.0% of the stated amount. IDENTIFICATION Shake a quantity of the powdered tablets containing the equivalent of…<\/p>\n","protected":false},"author":5,"featured_media":22879,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[176],"tags":[],"class_list":["post-22878","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-british-pharmacopoeia-veterinary-2020"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22878","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=22878"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22878\/revisions"}],"predecessor-version":[{"id":22886,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22878\/revisions\/22886"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/22879"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=22878"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=22878"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=22878"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

TESTS<\/h2>\n

Dissolution<\/h3>\nComply with the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n

TEST CONDITIONS<\/h4>\n(a) Use Apparatus 1, rotating the basket at 100 revolutions per minute.<\/p>\n(b) Use 900 mL of a solution containing 0.68% w\/v of potassium dihydrogen phosphate and 0.063% w\/v of sodium hydroxide at a temperature of 37\u00b0 as the medium.<\/p>\n

LIMITS<\/h4>\nThe amount of clindamycin released is not less than 80% (Q) of the stated amount.<\/p>\n

SYSTEM SUITABILITY<\/h4>\nThe test is not valid unless, in the chromatogram obtained with solution (3):<\/p>\nthe resolution between the peaks due to impurity B and impurity C is at least 3.0 and; the resolution between the peaks due to impurity C and clindamycin is at least 2.0.<\/p>\n

Water<\/h3>\nThe tablets contain not more than 6.0% w\/w, Appendix IX C. Use 0.1 g.<\/p>\n

CHROMATOGRAPHIC CONDITIONS<\/h3>\nThe chromatographic conditions described under Dissolution may be used.<\/p>\n

LABELLING<\/h2>\nThe quantity of active ingredient is stated in terms of the equivalent amount of clindamycin.<\/p>\n

Dissolution<\/h3>\n
Comply with the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n

TEST CONDITIONS<\/h4>\n
(a) Use Apparatus 1, rotating the basket at 100 revolutions per minute.<\/p>\n
(b) Use 900 mL of a solution containing 0.68% w\/v of potassium dihydrogen phosphate and 0.063% w\/v of sodium hydroxide at a temperature of 37\u00b0 as the medium.<\/p>\n

LIMITS<\/h4>\n
The amount of clindamycin released is not less than 80% (Q) of the stated amount.<\/p>\n

SYSTEM SUITABILITY<\/h4>\n
The test is not valid unless, in the chromatogram obtained with solution (3):<\/p>\n
the resolution between the peaks due to impurity B and impurity C is at least 3.0 and; the resolution between the peaks due to impurity C and clindamycin is at least 2.0.<\/p>\n

Water<\/h3>\n
The tablets contain not more than 6.0% w\/w, Appendix IX C. Use 0.1 g.<\/p>\n

CHROMATOGRAPHIC CONDITIONS<\/h3>\n
The chromatographic conditions described under Dissolution may be used.<\/p>\n

LABELLING<\/h2>\n
The quantity of active ingredient is stated in terms of the equivalent amount of clindamycin.<\/p>\n