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

General Notices<\/div>\n

Action and use<\/strong><\/div>\n
Cytotoxic alkylating drug.<\/div>\n
DEFINITION<\/h2>\n
Hydroxycarbamide Capsules contain Hydroxycarbamide.<\/div>\n
The capsules comply with the requirements stated under Capsules and with the following requirements.<\/div>\n
Content of hydroxycarbamide, CH_{4<\/sub>N_{2<\/sub>O_{2<\/sub><\/strong><\/div>\n95.0 to 105.0% of the stated amount.<\/div>\nIDENTIFICATION<\/h2>\nA. Shake a quantity of the contents of the capsules containing 30 mg of Hydroxycarbamide with 10 mL of methanol and filter. Evaporate the filtrate to dryness and dry the residue at 60\u00b0 at a pressure of 2 kPa for 3 hours. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of hydroxycarbamide (RS 184).<\/div>\nB. In the Assay, the chromatogram obtained with solution (1) shows a peak with the same retention time as that of the principal peak in the chromatogram obtained with solution (2).<\/div>\nTESTS<\/h2>\nUrea<\/strong><\/div>\nCarry out the method for thin-layer chromatography, Appendix III A, using the following solutions in water.<\/div>\n(1) Shake a quantity of the contents of the capsules containing 0.5 g of Hydroxycarbamide with 10 mL of water for 15 minutes and filter through a glass-fibre filter (Whatman GF\/C is suitable).<\/div>\n(2) 0.025% w\/v of urea.<\/div>\n(3) 5.0% w\/v of hydroxycarbamide BPCRS and 0.025% w\/v of urea.<\/div>\nCHROMATOGRAPHIC CONDITIONS<\/div>\n(a) Use as the coating silica gel.<\/div>\n(b) Use the mobile phase as described below.<\/div>\n(c) Apply 10 \u03bcL of each solution.<\/div>\n(d) Develop the plate to 15 cm.<\/div>\n(e) After removal of the plate, dry in air, spray with a 1% w\/v solution of 4-dimethylaminobenzaldehyde in 1M hydrochloric acid.<\/div>\nMOBILE PHASE<\/div>\nHydroxycarbamide Capsules<\/div>\n1 volume of pyridine, 1 volume of water and 5 volumes of ethyl acetate. Shake, allow to separate and use the upper layer.<\/div>\nSYSTEM SUITABILITY<\/div>\nThe test is not valid unless the chromatogram obtained with solution (3) shows two clearly separated spots.<\/div>\nLIMITS<\/div>\nAny spot corresponding to urea in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) (0.5%).<\/div>\nHydroxylamine<\/strong><\/div>\nCarry out the method for liquid chromatography, Appendix III D, using the following solutions in water.<\/div>\n(1) Shake a quantity of the contents of the capsules containing 0.1 g of Hydroxycarbamide with 8 mL of water for 5 minutes, add sufficient water to produce 10 mL and filter through a glass-fibre filter (Whatman GF\/C is suitable).<\/div>\n(2) 1.0% w\/v of hydroxycarbamide BPCRS and 0.02% w\/v of hydroxylamine hydrochloride.<\/div>\n(3) 0.1% w\/v of hydroxycarbamide BPCRS and 1.0% w\/v of hydroxylamine hydrochloride.<\/div>\nCHROMATOGRAPHIC CONDITIONS<\/div>\n(a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 \u03bcm) (Spherisorb ODS is suitable).<\/div>\n(b) Use isocratic elution and the mobile phase described below.<\/div>\n(c) Use a flow rate of 0.5 mL per minute.<\/div>\n(d) Use an ambient column temperature.<\/div>\n(e) Use a detection wavelength of 214 nm.<\/div>\n(f) Inject 20 \u03bcL of each solution.<\/div>\nMOBILE PHASE<\/div>\n5 volumes of methanol and 95 volumes of water.<\/div>\nSYSTEM SUITABILITY<\/div>\nThe test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to hydroxycarbamide and hydroxylamine is at least 2.0.<\/div>\nLIMITS<\/div>\nIn the chromatogram obtained with solution (1): the area of any peak corresponding to hydroxylamine is not greater than the area of the corresponding peak in the chromatogram obtained with solution (2) (1%).<\/div>\nASSAY<\/h2>\nWeigh and powder the contents of 20 capsules. Carry out the method for liquid chromatography, Appendix III D, using the following solutions in water.<\/div>\n(1) Shake a quantity of the capsule contents containing 1 g of Hydroxycarbamide with 450 mL of water for 5 minutes, mix for 30 minutes with the aid of ultrasound, add sufficient water to produce 500 mL and mix well. Filter through a glass-fibre filter (Whatman GF\/C is suitable) and dilute 1 volume of the filtrate with 1 volume of water.<\/div>\n(2) 0.10% w\/v of hydroxycarbamide BPCRS<\/div>\n(3) 0.10% w\/v of hydroxycarbamide BPCRS and 0.4% w\/v of hydroxylamine hydrochloride.<\/div>\nCHROMATOGRAPHIC CONDITIONS<\/div>\n(a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 \u03bcm) (Spherisorb ODS 2 is suitable).<\/div>\n(b) Use isocratic elution and the mobile phase described below.<\/div>\n(c) Use a flow rate of 0.5 mL per minute.<\/div>\n(d) Use an ambient column temperature.<\/div>\n(e) Use a detection wavelength of 214 nm.<\/div>\n(f) Inject 20 \u03bcL of each solution.<\/div>\nMOBILE PHASE<\/div>\nwater.<\/div>\nSYSTEM SUITABILITY<\/div>\nThe test is not valid unless, in the chromatogram obtained with solution (3), the resolution between hydroxycarbamide and hydroxylamine hydrochloride is at least 1.0.<\/div>\nDETERMINATION OF CONTENT<\/div>\nCalculate the content of CH_{4<\/sub>N_{2<\/sub>O_{2<\/sub> in the capsules using the declared content of CH_{4<\/sub>N_{2<\/sub>O_{2<\/sub> in hydroxycarbamide BPCRS.<\/div>\n<\/div>\nSTORAGE<\/h2>\nHydroxycarbamide Capsules should be protected from moisture.<\/div>\n","protected":false},"excerpt":{"rendered":"Edition: BP 2025 (Ph. Eur. 11.6 update) General Notices Action and use Cytotoxic alkylating drug. DEFINITION Hydroxycarbamide Capsules contain Hydroxycarbamide. The capsules comply with the requirements stated under Capsules and with the following requirements. Content of hydroxycarbamide, CH4N2O2 95.0 to 105.0% of the stated amount. IDENTIFICATION A. Shake a quantity of the contents of the…<\/p>\n","protected":false},"author":5,"featured_media":17804,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-17846","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\/17846","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=17846"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/17846\/revisions"}],"predecessor-version":[{"id":17874,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/17846\/revisions\/17874"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/17804"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=17846"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=17846"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=17846"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}}}}}}}}}}