MAIZE STARCH - uspbpep.com

1 MAIZE oil, refined EUROPEAN PHARMACOPOEIA Chlorides ( ) : maximum 500 ppm. IDENTIFICATION. Dilute ml of solution S to 15 ml with water R. Prepare A. Carry out the identification of fatty oils by thin-layer the standard using a mixture of 5 ml of chloride standard chromatography ( ). The chromatogram obtained solution (5 ppm Cl) R and 10 ml of water R. with the test solution is similar to that obtained with the Sulphates ( ) : maximum per cent. reference solution. Dilute ml of solution S to 15 ml with distilled water R. B. It complies with the test for composition of fatty acids (see Tests). Arsenic ( , method A) : maximum 4 ppm, determined on ml of solution S.

2 TESTS. Heavy metals ( ) : maximum 40 ppm. Acid value ( ). Not more than , determined on g. Neutralise 10 ml of solution S with dilute ammonia R1, If intended for use in the manufacture of parenteral dosage using metanil yellow solution R as an external indicator. forms, not more than Dilute to 20 ml with water R and filter if necessary. 12 ml Peroxide value ( ). Not more than If intended for of this solution complies with test A. Prepare the reference use in the manufacture of parenteral dosage forms, not more solution using lead standard solution (2 ppm Pb) R. than Loss on ignition : 17 per cent to 34 per cent, determined Unsaponifiable matter ( ).

3 Not more than per cent, on g by ignition to constant mass at 900 50 C in a determined on g. platinum crucible. Alkaline impurities ( ). It complies with the test for Acid-absorbing capacity. Suspend g in M alkaline impurities in fatty oils. hydrochloric acid, dilute to ml with the same acid Composition of fatty acids ( , Method A). The fatty-acid and allow to stand for 2 h in a water-bath at 37 C, fraction of the oil has the following composition : with frequent shaking. Allow to cool. To ml of the supernatant solution add ml of bromophenol blue fatty acids of chain length less than C16 : not more than solution R and titrate with M sodium hydroxide until a per cent, blue colour is obtained.

4 The acid-absorbing capacity is not palmitic acid : per cent to per cent, less than ml of M hydrochloric acid per gram. stearic acid : not more than per cent, oleic acid : per cent to per cent (equivalent ASSAY. chain length on polyethyleneglycol adipate ), Magnesium oxide. To g in a 200 ml conical flask, linoleic acid : per cent to per cent (equivalent add 35 ml of hydrochloric acid R and 60 ml of water R chain length on polyethyleneglycol adipate ), and heat in a water-bath for 15 min. Allow to cool, filter, wash the conical flask and the residue with water R and linolenic acid : per cent to per cent (equivalent dilute the combined filtrate and washings to ml with chain length on polyethyleneglycol adipate ), water R.

5 Neutralise ml of the solution with strong arachidic acid : not more than per cent, sodium hydroxide solution R (about 8 ml). Carry out the eicosenoic acid : not more than per cent (equivalent complexometric titration of magnesium ( ). chain length on polyethyleneglycol adipate ), 1 ml of M sodium edetate is equivalent to mg behenic acid : not more than per cent, of MgO. other fatty acids : not more than per cent. Silicon dioxide. To g add 10 ml of dilute sulphuric Sterols. Determined by gas chromatography ( ), the acid R and 10 ml of water R. Heat for 90 min on a water-bath sterol fraction of the oil contains not more than per cent with frequent shaking, replacing the evaporated water.

6 Allow of brassicasterol. to cool and decant onto an ashless filter paper (diameter Water ( ). If intended for use in the manufacture 7 cm). Wash the precipitate by decantation with 3 quantities, of parenteral dosage forms, not more than per cent, each of 5 ml, of hot water R, transfer it to the filter and wash determined on g by the micro-determination of water. it with hot water R until 1 ml of the filtrate remains clear Use a mixture of equal volumes of decanol R and anhydrous after the addition of ml of dilute hydrochloric acid R. methanol R as the solvent. and 2 ml of barium chloride solution R1. Incinerate the filter and its contents in a platinum crucible, then ignite the STORAGE.

7 Residue (SiO2) at 900 50 C to constant mass. Store protected from light, at a temperature not exceeding 25 C. 01/2008:1342 LABELLING. The label states : MAIZE OIL, REFINED where applicable, that the substance is suitable for use in the manufacture of parenteral dosage forms, Maydis oleum raffinatum whether the oil is obtained by mechanical expression or DEFINITION by extraction. Refined MAIZE oil is the fatty oil obtained from the seeds of Zea mays L. by expression or by extraction, then refined. 01/2008:0344. CHARACTERS MAIZE STARCH . A clear, light yellow or yellow oil, practically insoluble in water and in alcohol, miscible with light petroleum (bp : Maydis amylum 40 C to 60 C) and with methylene chloride.

8 It has a relative density of about and a refractive index DEFINITION. of about MAIZE STARCH is obtained from the caryopsis of Zea mays L. 2326 See the information section on general monographs (cover pages). EUROPEAN PHARMACOPOEIA Malathion CHARACTERS DEFINITION. Appearance : matt, white to slightly yellowish, very fine Diethyl (2RS)-2-(dimethoxyphosphinodithioyl)buta nedioate. powder which creaks when pressed between the fingers. Content : per cent to per cent (anhydrous Solubility : practically insoluble in cold water and in ethanol substance). (96 per cent). The presence of granules with cracks or irregularities on CHARACTERS.

9 The edge is exceptional. Appearance : clear, colourless or slightly yellowish liquid. Solubility : slightly soluble in water, miscible with acetone, IDENTIFICATION with cyclohexane, with ethanol (96 per cent) and with A. Examined under a microscope, using not less than vegetable oils. 20 magnification and using equal volumes of glycerol R. It solidifies at about 3 C. and water R, it appears as either angular polyhedral granules of irregular sizes with diameters ranging from IDENTIFICATION. about 2 m to about 23 m or as rounded or spheroidal granules of irregular sizes with diameters ranging from Infrared absorption spectrophotometry ( ).

10 About 25 m to about 35 m. The central hilum consists Comparison : malathion CRS. of a distinct cavity or two-to five-rayed cleft and there are no concentric striations. Between crossed nicol TESTS. prisms, the STARCH granules show a distinct black cross Relative density ( ) : to intersecting at the hilum. Optical rotation ( ) : to + . B. Suspend 1 g in 50 ml of water R, boil for 1 min and cool. Dissolve g in ethanol (96 per cent) R and dilute to A thin, cloudy mucilage is formed. ml with the same solvent. C. To 1 ml of the mucilage obtained in identification test B. Related substances. Liquid chromatography ( ). add ml of iodine solution R1.