impulses cause the continence (i.e relaxation of tne detrusor and contraction of the sphincter). When the bladder is filled

impulses cause the continence (i.e relaxation of tne detrusor and contraction of the sphincter). When the bladder is filled, the micturition reflex is initiated and now the maintenance reflex is overcome so that evacuation of bladder can occur applied physiology 1. Automatic bladder. From theoretical consideration it can be magined that when the spinal center is intact, the peripheral nerves supplying the bladder, as well as the bladder muscles, are healthy, but the connection between the higher (= cortical) and spinal centers are lost (or not developed), the bladder will be automatic, that is, whenever the filling of the bladder will reach a required point, the micturition reflex will be set up and evacuation will result, no matter whether it is convenient or inconvenient to pass urine Such a situation, i. e. automatic bladder, develops in a particular stage (phase) of transaction of spinal cord (for details, see chap. 8, sec. XD). In the Infants also, the higher control is not satisfactorily developed and so the evacuation of bladder is rather automatic. Retention Retention of urine in the bladder may be due to anatomical or functional reasons. Common anatomical causes are, (I) enlarged prostate (enlargement may be benign or cancerous) mechanically obstructng the urethral canal and (ji) stricture of the urethra (the stricture may be due to gonorrheal) infection). Functional causes are very commonly due to nervous system disorders. Thus, in the spinal shock (ch. 8, sec. XD) and in the initial phases of hemiplegia, the urine accumulates on and the bladder becomes distended and yet the bladder does not evacuate itself. Both in the spinal shock and earty stage of hemiplegia. spinal centers remain in a state of functionlessness for a variable period When they begin to regain funcbon, the function of the sphincter returns earlier than the detrusor, causing the retention. Effects of emotion it has been already stated that as the urine accumulates more and more, up to a certain stage, the detrusor relaxes so that pressure within the bladder does not rise and the desire for micturition does not develop. However, when a subject is excited or becomes anxious, the ability ofthe detrusor to relax is reduced and the desire for micturition develops even when the bladder contains only small quantity of urine. As a result frequency of urination can develop (e. g. in a panicky person). Effects of pregnancy Pregnancy causes a remarkable loss of tone of the detrusor muscle As a result, the pressure within the bladder remains low even when the volume of urine within it is quite high, and the desire to micturate does not occur. During urination, such bladder may not be completely emptied. The continued presence of residual urine may cause bacterial Infection which is rather common in pregnancy. Plainly, it is somewhat a3dn to the receptive relaxation of the stomach. 1. Functional anatomy: the two types of skin Appendages microscopic anatomy of the skin hairs sweat glands. Sebaceous glands color of the skin nails. 2. Functions of the skin

CAPTOPRIL TABLETS Usual strengths: 12.5 mg, 25 mg, 50 mg. Storage Store in tightly-closed containers. STANDARDSCaptopril Tablets

substance being examined and (2) 0.4% w/v of captopril RS. After removal of the plate, allow it to dry in air and spray with a freshly prepared mixture of 1 volume of strong ammonia solution and 6 volumes of a 0.04% w/v solution of 5,5'-dithiobds(2-nitrobenzoic acid) in methanol and allow to stand for 5 minutes. The principal band in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2).C: Melts between 104° and 110°, Appendix 8.8 Specific optical rotation: Between-125° and-134°, determined in a 1 % w/v solution in ethanol, Appendix 8.9. Heavy metals: Not more than 30 ppm, determined on 0.66 g by Method B, Appendix 3.12 Sulphated ash: Not more than 0.2%, Appendix 3.22. Loss on drying: Not more than 1.0%, determined on 1 g by drying at 600 at a pressure not exceeding 0.7 kPa, Appendix 8.6 Assay: Weigh accurately about 0.3 g, dissolve in 100 ml of water in a stoppered-flask, add 10 ml of 1.8M sulphuric acid and 1 g of potassium iodide. Titrate with 0.025M potassium iodate using 3 ml of starch solution, added towards the end-point, as indicator. Each ml of 0.025M potassium iodate is equivalent to 0.03308 g of C9H15NO3S. CAPTOPRIL TABLETS Usual strengths: 12.5 mg, 25 mg, 50 mg. Storage Store in tightly-closed containers. STANDARDSCaptopril Tablets contain not less than 90.0 per cent and not more than I 10.0 per cent of the stated amount of captopril, C9H15NO3S Identification: A: Comply with test B described under Captopril, using as solution (1) the clear supernatant liquid obtained by extracting the powdered tablets equivalent to 100 mg of Captopril with 25 ml of methanol and centrifuging. Dissolution: Comply with the dissolution test far tablets and capsules. Appendix 7.3, using Apparatus 2, as the medium 900 ml of 0.1M hydrochloric acid and rotating the basket at 50 rpm for 20 minutes. Withdraw a suitable volume of the sample and filter. Measure the absorbance of the filtrate, suitably diluted with the dissolution medium, if necessary, at the maximum at about 212 nm. Appendix 5.5. Calculate the content of CGH15NO3S in the medium from the absorbance obtained from a solution of known concentration of captopril RS in the same medium and from the declared content of C9H15NO3S in captopril RS.D: Not less than 80% of the stated amount of C9H15NO3S. Other requirements: Comply with the 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) dissolve a quantity of the finely powdered tablets equivalent to about 25 mg of Captopril in 25 ml of the mobile phase by ultrasonic treatment for 15 minutes, centrifuge 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 4.6 mm) packed with stationary phase LCI, (b) a degassed mixture of 55 volumes of methanol and 45 volumes of water containing 0.05 volume of phosphoric acid as the mobile phase with a flow 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

BENZATHINE PENICILLIN INJECTIONBenzathine Berizylpenicihin Injection, Benzathine Penicillin G Injection Benzathine Penicillin Injection

: For penicillins - Weigh accurately about 70 mg, dissolve in 20 ml of methanol, add 5 ml of water and 5 ml of 1 M sodium hydroxide and allow to stand for 15 minutes. Add 5 ml of IM nitric acid, 20 ml of acetate buffer pH 4.6 and 20 ml of water and titrate at 35° to 40° with 0. 02M mercuric nitrate. Titrate slowly so that the titration takes about 15 minutes Determine the end-point potentiometrically using a platinum or mercury -indicator electrode and a mercury mercurous sulphate reference electrode. (Cleaningthe reference electrode with dilute nitric acid and the indicator electrode with a 10% w/v solution of sodium thiosulphate followed by rinsing with distilled water is recommended after each assay). Ignore any preliminary inflection on the titration curve. Each ml of 0.02M mercuric nitrate is equivalent to 0.009091 g of total penicillins, calculated as C16H20N2(C16H18N2O4S)2 To a further 0.25 g dissolved in 50 ml of methanol add 25 ml of acetate buffer pH 4.6 and shake until solution is complete. Titrate immediately at room temperature with 0. 02M mercuric nitrate determining the end-point as above. Each ml of 0.02M mercuric nitrate is equivalent to 0.009091 g of degradation products, calculated as C16H20N2(C16H18N2O4S)2 Calculate the percentage content of total penicillins and the percentage content of degradation products. The difference between the two percentages is the content of penicillins. For N,N'-dibenzylethylenediamine - Weigh accurately about 1 g, add 30 ml of a saturated solution of sodium chloride and 10 ml of 5M sodium hydroxide, shake well and extract with four quantities, each of 50 ml, of ether. Wash the combined extracts with three quantities, each of 10 ml, of water, extract the combined washings with 25 ml of ether and add the extract to the main ether solution. Evaporate the ether solution to a low bulk, add 2 ml of ethanol and evaporate to dry ness Dissolve the residue in 50 ml of anhydrous glacial acetic acid and carry out Method B for non-aqueous titration, Appendix 3.45, using 1 ml of naphtholbenzein solution as indicator. Perform a blank determination and make any necessary correction. Each ml of 0.1M perchloric acid is equivalent to 0.01202 g of C16H20N2. Benzathine Penicillin intended for use in the manufacture of injectable preparations complies with the following additional requirements. Pyrogens: Complies with the test for pyrogens, Appendix 2.6, using per kg of the rabbit's weight 1 ml of the supernatant liquid obtaind by suspending 40 mg in 20 ml of water for injection, shaking thoroughly and centrifuging. Sterility: Complies with the tests for sterility, Appendix 9.5 BENZATHINE PENICILLIN INJECTIONBenzathine Berizylpenicihin Injection, Benzathine Penicillin G Injection Benzathine Penicillin Injection is a sterile suspension of Benzalhine Penicillin in Water for Injection. It is prepared by adding to the contents of a seated container the requisite amount of Water for Injection, the seated container, may contain suitable buffering agents and other 'pharmaceutical aids. Usual strength: 450 mg (600,000 Units) (Each mg of Benzathine Penicillin is

: For penicillins - Weigh accurately about 70 mg, dissolve in 20 ml of methanol, add 5 ml of water and 5 ml of 1 M sodium hydroxide and allow to stand

: For penicillins - Weigh accurately about 70 mg, dissolve in 20 ml of methanol, add 5 ml of water and 5 ml of 1 M sodium hydroxide and allow to stand for 15 minutes. Add 5 ml of IM nitric acid, 20 ml of acetate buffer pH 4.6 and 20 ml of water and titrate at 35° to 40° with 0. 02M mercuric nitrate. Titrate slowly so that the titration takes about 15 minutes Determine the end-point potentiometrically using a platinum or mercury -indicator electrode and a mercury mercurous sulphate reference electrode. (Cleaningthe reference electrode with dilute nitric acid and the indicator electrode with a 10% w/v solution of sodium thiosulphate followed by rinsing with distilled water is recommended after each assay). Ignore any preliminary inflection on the titration curve. Each ml of 0.02M mercuric nitrate is equivalent to 0.009091 g of total penicillins, calculated as C16H20N2(C16H18N2O4S)2 To a further 0.25 g dissolved in 50 ml of methanol add 25 ml of acetate buffer pH 4.6 and shake until solution is complete. Titrate immediately at room temperature with 0. 02M mercuric nitrate determining the end-point as above. Each ml of 0.02M mercuric nitrate is equivalent to 0.009091 g of degradation products, calculated as C16H20N2(C16H18N2O4S)2 Calculate the percentage content of total penicillins and the percentage content of degradation products. The difference between the two percentages is the content of penicillins. For N,N'-dibenzylethylenediamine - Weigh accurately about 1 g, add 30 ml of a saturated solution of sodium chloride and 10 ml of 5M sodium hydroxide, shake well and extract with four quantities, each of 50 ml, of ether. Wash the combined extracts with three quantities, each of 10 ml, of water, extract the combined washings with 25 ml of ether and add the extract to the main ether solution. Evaporate the ether solution to a low bulk, add 2 ml of ethanol and evaporate to dry ness Dissolve the residue in 50 ml of anhydrous glacial acetic acid and carry out Method B for non-aqueous titration, Appendix 3.45, using 1 ml of naphtholbenzein solution as indicator. Perform a blank determination and make any necessary correction. Each ml of 0.1M perchloric acid is equivalent to 0.01202 g of C16H20N2. Benzathine Penicillin intended for use in the manufacture of injectable preparations complies with the following additional requirements. Pyrogens: Complies with the test for pyrogens, Appendix 2.6, using per kg of the rabbit's weight 1 ml of the supernatant liquid obtaind by suspending 40 mg in 20 ml of water for injection, shaking thoroughly and centrifuging. Sterility: Complies with the tests for sterility, Appendix 9.5 BENZATHINE PENICILLIN INJECTIONBenzathine Berizylpenicihin Injection, Benzathine Penicillin G Injection Benzathine Penicillin Injection is a sterile suspension of Benzalhine Penicillin in Water for Injection. It is prepared by adding to the contents of a seated container the requisite amount of Water for Injection, the seated container, may contain suitable buffering agents and other 'pharmaceutical aids. Usual strength: 450 mg (600,000 Units) (Each mg of Benzathine Penicillin is

Prophylactic, by intramuscular injection, 900 mg (1,200,000 Units) every 2 or 3 weeks [900 mg of Benzthine Penicillin

[300,000 Units) to 750 mg (1,000,000 Units). Prophylactic, by intramuscular injection, 900 mg (1,200,000 Units) every 2 or 3 weeks [900 mg of Benzthine Penicillin is approximately equivalenl lo 720 mg of benzylpenicillm (1,200,000 Unils of penicillin)]. Description: White, crystalline powder, almost odourless. Solubility: Freely soluble in formamide. and dimethylformamide, slightly soluble in ethanol (95%); very slightly soluble in chloroform and in water, practically insoluble in ether. Storage: Store in lightly-closed containers in a cool, dry place. If the material is intended for use in the manufacture of injectable preparations the container should be sterile and sealed so as to exclude micro-organisms. Labelling: The label states whether or not the contents are intended for use in the manufacture of injectable preparations. STANDARDSBenzathine Penicillin contains not less than 96.0 per cent and not more than 100.5 per cent of penicillins, calculated as C16H20N2(C16H18N2O4S)2 and not less than 24,0 per cent and not more than 27.0 per cent ofN.N'-dibenzylethylenediamineC16H20N2 both calculated with reference to the anhydrous substance. Identification: Test A may be omitted if tests B, C and D are carried out. Tests B, C and D may be omitted if test A is carried out. A: The infra-red absorption spectrum, Appendix 5.4, is concordant with the reference spectrum of benzathine penicillin or with spectrum obtained from benzathine penicillin RS. B: Shake 0.1 g with 1 ml of 1M sodium hydroxide for 2 minutes, add 2 ml of ether, shake for 1 minute and allow to separate Evaporate 1 ml of the ether layer to dryness, dissolve the residue in 2 ml of glacial acetic acid and add 1 ml of potassium dichromate solution; a golden yellow precipitate is formed. C: Shake 0.1 g with 2 ml of 1M sodium hydroxide for 2 minutes, extract the mixture with two quantities, each of 3 ml, of ether, evaporate the combined extracts and dissolve the residue in 1 ml of ethanol (50%) Add 5 ml of picric acid solution, heat at 90° for 5 minutes and allow to cool slowly, the precipitale, after recrystall isation from ethanol (25%) containing a small quantity of picric acid melts at about 214° Appendix 8.8.D: Gives the reactions of penicillins and cephalosporins, Appendix 3.1 pH: Between 5.0 and 7.5, determined in a saturated solution, Appendix 8.11. Water: Between 5.0 and 8.0% w/w, determined on 0.3 g, Appendix 3.24. Assay

and add sufficient water to produce 10.0.0 ml. Place two quantities, each of 2 ml, of the solution in separate stoppered tubes.

degradation products from the calculated percentage content of total penicillins to calculate the percentage content of amoxycillm sodium. Amoxycilln Sodium intended for use in the manufacture of injectable preparations complies with the following additional requirements. Pyrogens: Complies with the test for pyrogens, Appendix 2.6, using 1 ml of a solution in water for injection containing 20 mg per ml per kg of the rabbit's weight. Sterility: Complies with the tests for sterility, Appendix 9.5 AMOXYCILLIN SODIUM INJECTION Amoxycillin Injection; Amoxicilln Sodium Injection; Amoxicillin Injection Amoxycillin Sodium Injection is a sterile solution of Amoxycillin Sodium in Water for Injection. It is prepared by dissolving the contents of a sealed container in the requisite amount of Water for Injectionimmediately before use. Usual strengths: The equivalent of 100 mg, 250 mg, 500 mg and 1 g of amoxycillin. Storage: Store m a cool, dry place. The reconstituted solution should be used immediately after preparation. Labelling: The label states the quantity of Amoxycillin Sodium contained in the sealed container in terms of the equivalent amount of amoxycillm. STANDARDSAmoxycillin Sodium Injection contains not less than 90.0 per cent and not more than 120.0 per cent of the stated amount of amoxycillin, C16H19N3O5S. The injection complies with the requirements of tests stated under Injectable Preparations (Powders for Injection). The contents of the sealed container comply with the following requirements. Description: White or almost white amorphous powder, very hygroscopic. Identification; pH; Clarity and colour of solution; Specific optical rotation; NN-Dimethylanilne, Degradation products; Water;Pyrogens; Sterility: Comply with the requirements stated under Amoxycillin Sodium. Assay: Determine the weight of the contents of 10 containers. Dissolve 0.17 g of the mixed contents of the 10 containers in sufficient water to\ produce 500.0 ml. Transfer 10.0 ml of the resulting solution to a 100-m1 volumetric flask, add 10 ml of alkaline borate buffer pH 9.0 followed by I ml of acetic anhydnde-dioxan solution, allow to stand for 5 minutes and add sufficient water to produce 10.0.0 ml. Place two quantities, each of 2 ml, of the solution in separate stoppered tubes. To one tube add 10 ml of imidazole-mercury reagent, stopper the tube and place in a water-bath at 60° for

a platinum or mercury indicator electrode and a mercury - mercurous sulphate reference electrode. Ignore any preliminary inflection

Weigh accurately about 250 mg, dissolve in a mixture of 25 ml of alkaline borate buffer pH 9.0 and 0.5 ml of acetic anhydride by stirring for 3 minutes, add 10 ml of acetate buffer pH 4.6 and titrate immediately with 0.02M mercuric nitrate, determining the end-point potentiometrically with a platinum or mercury indicator electrode and a mercury - mercurous sulphate reference electrode. Ignore any preliminary inflection in the titration curve. Each ml of 0.02M mercuric nitrate is equivalent to 0.007748 g of degradation products calculated as C C16H18NaO5S. 2-Ethylhexanoic acid. Not more than 2.0%, determined by the following method. Carry out the method for gas chromatography, Appendix 4.2, injecting 1 ul of each of the following solutions. Prepare a 1.0% w/v solution of valeric acid (internal standard) in hexane (solution A). For solution (1) dissolve 1.0 g of the substance being examined in 5 ml of water in a glass-stoppered flask, add 3 ml of 2M hydrochloric acid, 1 ml of solution A and 5 ml of hexane, shake vigorously for 1 minute, centrifuge if necessary and use the clear supernatant layer. Solutions (2) and (3) are prepared in thesame manner but using an extra 1 ml of hexane in place of solution A for solution (2) and 20 mg of 2 ethylhexanoic acid suspended in 5 ml of water in place of the substance being examined for solution (3). The chromatographic procedure may be carried out using (a) a column (1.8 m x 4 mm) packed with a support impregnated with a stationary phase suitable for the separation of free fatty acaidsa (a column containing 10% of SP 1200 and 1% of phosphoric acid on Chromosorb W AW, 80-100 mesh, is suitable) and maintained at 145° with detector temperature of 150°, (b) a flame lonisation detector maintained at 150° and (c) a flow rate of 45 ml per minute of the carrier gas. Water: Not more than 4.0% w/w, determined on 0.4 g, Appendix 3.24 Assay. Weigh accurately about 50 mg, dissolve in 1.0 ml of alkaline