requirements of tests stated under Tablets Assay; Protect The solutions from exposure to air and use within 8 hours of preparation. Carry out the method for high performance liquid chromatography, Appendix 4.3, using the following solutions. For solution (1) dssolve a quantity ol the finely powdered tablets equivalent to about 25 mg of Captoprrl In 25 ml of the mobile phase by ultrasonic treatment for 15 minutes, cenirltuge and use the clear supernatant liquid Solution (2) contains 0.1 % w/v of captopril RS in the mobile phase. Carry out the chromatographic procedure using (a) a stainless steel column (25 cm x 46 mm) packed with stationary phase LClh (b) a degassed mixture of 55 volumes of methanol and 45 volumes of water containing 0. 05 voume of phosphoric acid as the mobile phase with aflow rate of 1 ml per minute and (c) a detection wavelength of about 220 nm Calculate the content of C9H15NO3S from the declared content of C9H15NO3S in captopril RS. CARAMEL Burnt Sugar Caramel is a concentrated solution of the product obtained by heating Sucrose or Dextrose until the sweet taste is destroyed. Category Pharmaceutical aid (colouring agent). Description; Thick, free-flowing, dark brown liquid odour, slight and characteristic. Solubility; Misdble with water, with dilute alcohols (upto 60% v/v), with dilute mineral acide and wilh solulions of sodium hydroxide, immiscible with chloroform and with ether. it is precipitated by strong alcohole (more than 60% v/v) Storage; Store in tghtly-closed containers STANDARDS Identification;To 20 ml of a 5% w/v solution add 0.5 ml of phosphoric acid no precipitate is produced.Weight per ml; Not less than 1. 30 g Appencix 3..l5pH; Between 3.0 and 5.5. determined in a 10% w/v solution. Appencix 8.11.Acid-stability; Dilute 50 ml of a
1 % w/v solution to 250 m! with water, add 5 ml of hydrochloric acid and heat gently to boiling under reflux. Allow to cool and set aside for 24 hours, the solution remains clear. Repeat the test on the same testsolution but boil for 30 rninules. the solution remains clear for 24 hours Heavy metals Not more than 10 ppm, determined on 2 g cy Method B, Appendx 3.12. Iron; Evaporate 0.44 g to dryness, add
0.2 ml of nitric acid. Ignite and desolve the residue in 1 ml of dilute nitric acid the solution complies with the limit test for iron, Appendix 3.13 (100 ppm).Sulphated ash; Not more than 2.0%. Appendix 3.22. Microblal limits: 1.0 g is free from Eschenchie coll and salmonellae. Appencix 9.4.CARBAMAZEPINEC15H12N20 Mol. Wt. 236.27 Carbamazepine is 5H-c§benz(b,flazepine-5-carboxamide. Category Anticon vute ant Dose; 200 mg daily, increasing To 1.2 g daily, in divided doses, in accordance with the needs of the patient. Description. White or yellowish-white, crystalline powder, almost odourless, exhibits polymorphism Solubility. Freely soluble in dchloromethane, soluble In ethanol (95%) and In acetone, practically Insoluble in water and in ether. Storage; Store in well-closed containers. STAN DAR DSC arbamazeplne contains not less than 97.0 per cent and not more lhan 103.0 per cent of C15H12N2O. calculated with reference to the dried substance. Identification A Heal O. ! g with 2 ml of nitric acid in a water-bath for 3 minutes, an orange-red colour is produced B The light absorption in the range 230 to 360 run of a 0001% w/v solution in ethanol (95%) exhibits a
1 % w/v solution to 250 m! with water, add 5 ml of hydrochloric acid and heat gently to boiling under reflux. Allow to cool and set aside for 24 hours, the solution remains clear. Repeat the test on the same testsolution but boil for 30 rninules. the solution remains clear for 24 hours Heavy metals Not more than 10 ppm, determined on 2 g cy Method B, Appendx 3.12. Iron; Evaporate 0.44 g to dryness, add
0.2 ml of nitric acid. Ignite and desolve the residue in 1 ml of dilute nitric acid the solution complies with the limit test for iron, Appendix 3.13 (100 ppm).Sulphated ash; Not more than 2.0%. Appendix 3.22. Microblal limits: 1.0 g is free from Eschenchie coll and salmonellae. Appencix 9.4.CARBAMAZEPINEC15H12N20 Mol. Wt. 236.27 Carbamazepine is 5H-c§benz(b,flazepine-5-carboxamide. Category Anticon vute ant Dose; 200 mg daily, increasing To 1.2 g daily, in divided doses, in accordance with the needs of the patient. Description. White or yellowish-white, crystalline powder, almost odourless, exhibits polymorphism Solubility. Freely soluble in dchloromethane, soluble In ethanol (95%) and In acetone, practically Insoluble in water and in ether. Storage; Store in well-closed containers. STAN DAR DSC arbamazeplne contains not less than 97.0 per cent and not more lhan 103.0 per cent of C15H12N2O. calculated with reference to the dried substance. Identification A Heal O. ! g with 2 ml of nitric acid in a water-bath for 3 minutes, an orange-red colour is produced B The light absorption in the range 230 to 360 run of a 0001% w/v solution in ethanol (95%) exhibits a
No comments:
Post a Comment