Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n
General Notices<\/p>\n
Action and use<\/p>\n
Adrenoceptor agonist; reversal of hypotension from spinal or epidural anaesthesia.<\/p>\n
Ephedrine Injection is a sterile solution of Ephedrine Hydrochloride. It is supplied as a ready-to-use solution in Water for Injections or it is prepared immediately before use in accordance with the manufacturer\u2019s instructions from Ephedrine Sterile Concentrate.<\/p>\n
The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.<\/p>\n
When supplied as a ready-to-use solution, the injection complies with the following requirements.<\/p>\n
Content of ephedrine hydrochloride, C10H15NO,HCl<\/p>\n
95.0 to 105.0% of the stated amount.<\/p>\n
To a quantity of the injection containing 10 mg of Ephedrine Hydrochloride add 2 mL of 2M hydrochloric acid, shake with two 20-mL quantities of dichloromethane and discard the dichloromethane. Add 5M ammonia until the aqueous layer is alkaline, extract with two 30-mL quantities of a mixture of 3 volumes of dichloromethane and 1 volume of ethanol, dry the combined extracts over anhydrous sodium sulfate, filter and evaporate to dryness at a pressure of 2 kPa, heating gently to remove the last traces of solvent. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of ephedrine hydrochloride (RS 436).<\/p>\n
pH, 4.5 to 7.0, Appendix V L.<\/p>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n
(1) Dilute a volume of the injection, if necessary, with sufficient of the mobile phase to produce a solution containing 0.75% w\/v of Ephedrine Hydrochloride.<\/p>\n
(2) Dilute 1 volume of solution (1) to 500 volumes with mobile phase.<\/p>\n
(3) 0.01% w\/v of ephedrine hydrochloride BPCRS and 0.01% w\/v of pseudoephedrine hydrochloride BPCRS in mobile phase.<\/p>\n
(4) Dilute 1 volume of solution (2) to 10 volumes with mobile phase.<\/p>\n
(a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with phenyl silica gel for chromatography (5 \u00b5m) (Spherisorb Phenyl 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 257 nm.<\/p>\n
(f) Inject 20 \u00b5L of each solution.<\/p>\n
(g) Allow the chromatography to proceed for three times the retention time of the peak due to ephedrine.<\/p>\n
6 volumes of methanol and 94 volumes of a 1.16% w\/v solution of ammonium acetate adjusted to pH 4.0 using glacial acetic acid.<\/p>\n
When the chromatograms are recorded under the prescribed conditions, the retention time of ephedrine is about 13 minutes and the retention time of pseudoephedrine is about 16 minutes.<\/p>\n
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to ephedrine and pseudoephedrine is at least 2.0.<\/p>\n
In the chromatogram obtained with solution (1):<\/p>\n
the area of any secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);<\/p>\n
the sum of the areas of any secondary peaks is not greater than 2.5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.5%).<\/p>\n
Disregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (4) (0.02%).<\/p>\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 50 mg of Ephedrine Hydrochloride with 30 mL of methanol for 10 minutes, add sufficient water to produce 50 mL, filter through glass-fibre paper (Whatman GF\/C is suitable) and use the filtrate.<\/p>\n
(2) 0.1% w\/v of ephedrine hydrochloride BPCRS in methanol (60%).<\/p>\n
(a) Use a stainless steel column (20 cm \u00d7 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (10 \u00b5m) (Nucleosil C18 is suitable).
(b) Use isocratic elution and the mobile phase described below.
(c) Use a flow rate of 2 mL per minute.
(d) Use an ambient column temperature.
(e) Use a detection wavelength of 263 nm.
(f) Inject 20 \u00b5L of each solution.<\/p>\n
0.005M dioctyl sodium sulfosuccinate in a mixture of 1 volume of glacial acetic acid, 35 volumes of water and 65 volumes of methanol.<\/p>\n
Calculate the content of C10H15NO,HCl in the injection using the declared content of C10H15NO,HCl in ephedrine hydrochloride BPCRS.<\/p>\n
EPHEDRINE STERILE CONCENTRATE<\/strong><\/p>\n Ephedrine Sterile Concentrate is a sterile solution of Ephedrine Hydrochloride in Water for Injections. To a quantity of the concentrate containing 10 mg of Ephedrine Hydrochloride add 2 mL of 2M hydrochloric acid, shake with two 20-mL quantities of dichloromethane and discard the dichloromethane. Add 5M ammonia until the aqueous layer is alkaline, extract with two 30-mL quantities of a mixture of 3 volumes of dichloromethane and 1 volume of ethanol, dry the combined extracts over anhydrous sodium sulfate, filter and evaporate to dryness at a pressure of 2 kPa, heating gently to remove the last traces of solvent. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of ephedrine hydrochloride (RS 436).<\/p>\n Acidity Related substances Carry out the Assay described in the requirements for the ready to use injection.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) General Notices Action and use Adrenoceptor agonist; reversal of hypotension from spinal or epidural anaesthesia. DEFINITION Ephedrine Injection is a sterile solution of Ephedrine Hydrochloride. It is supplied as a ready-to-use solution in Water for Injections or it is prepared immediately before use in accordance with the manufacturer\u2019s…<\/p>\n","protected":false},"author":5,"featured_media":12189,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-12187","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\/12187","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=12187"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/12187\/revisions"}],"predecessor-version":[{"id":12207,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/12187\/revisions\/12207"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/12189"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=12187"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=12187"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=12187"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
The concentrate complies with the requirements for Concentrates for Injections or Infusions stated under Parenteral Preparations and with the following requirements.
Content of ephedrine hydrochloride, C10H15NO,HCl
95.0 to 105.0% of the stated amount.<\/p>\nIDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
pH, 4.5 to 7.0, Appendix V L.<\/p>\n
Carry out the method described in the requirements for the ready to use injection.<\/p>\nASSAY<\/h2>\n