Project Description

Medical Device Laboratory needed for EUropean Pharmacopeia Testing of Surgical threads to European Pharmacopeia [8.0] Monograph 01:2008:0324, IDENTIFICATION For (Silk sutures) Identification of silk: A. Dissect the end of a suture, using a needle or fine tweezers, to isolate a few individual fibres. The fibres are sometimes marked with very fine longitudinal striations parallel to the axis of the suture. Examined under a microscope, a cross-section is more or less triangular to semi-circular, with rounded edges and without a lumen. B. Impregnate isolated fibres with iodinated potassium iodide solution R. The fibres are coloured pale yellow. For UNILIN (Linen Sutures). Identification of linen A. Dissect the end of a suture, using a needle or fine tweezers, to isolate a few individual fibres. Examined under a microscope, the fibres are seen to be 12µm to 31µm wide and, along the greater part of their length, have thick walls, sometimes marked with fine longitudinal striations, and a narrow lumen. The fibres gradually narrow to a long, fine point. Sometimes there are unilateral swellings with transverse lines. For UNIMIDE / UNIMIDE C (Monofilament Nylon & polyeurothelene sutures) Identification of polyamide-6: It is practically insoluble in the usual organic solvents; it is not attacked by dilute alkaline solutions (for example a 100 g/l solution of sodium hydroxide R) but is attacked by dilute mineral acids (for example a 20 g/l solution of sulphuric acid R), by hot glacial acetic acid R and by a 70 per cent m/m solution of anhydrous formic acid R. A. Heat about 50mg with 0.5ml of hydrochloric acid R1 in a sealed glass tube at 110oC for 18 h and allow tostand for 6 h. No crystals appear. B. 50mg dissolves in 20 ml of a 70 per cent m/m solution of anhydrous formic acid R. For UNIMIDE B / UNIMIDE C (Braided Nylon & Sheathed Braided Nylon). Identification of polyamide-6/6: It is practically insoluble in the usual organic solvents; it is not attacked by dilute alkaline solutions (for example a 100 g/l solution of sodium hydroxide R) but is attacked by dilute mineral acids (for example a 20 g/l solution of sulphuric acid R), by hot glacial acetic acid R and by an 80 per cent m/m solution of anhydrous formic acid R. A. In contact with a flame it melts and burns, forming a hard globule of residue and gives off a characteristic odour resembling that of celery. B. Place about 50mg in an ignition tube held vertically and heat gently until thick fumes are evolved. When the fumes fill the tube, withdraw it from the flame and insert a strip of nitrobenzaldehyde paper R. A violet-brown colour slowly appears on the paper and fades slowly in air; it disappears almost immediately on washing with dilute sulphuric acid R. C. To about 50 mg add 10 ml of hydrochloride acid R1. The material disintegrates in the cold and dissolves within a few minutes. D. 50mg does not dissolve in 20 ml of a 70 per cent m/m solution of anhydrous formic acid R but dissolves in 20 ml of an 80 per cent m/m solution of anhydrous formic acid R. For UNIPRO (Polypropylene) Identification of polypropylene: Polypropylene is soluble in decahydronaphthalene, 1-chloronaphthalene and trichloroethylene. It is not soluble in alcohol, in ether and in cyclohexanone. A. It softens at temperatures between 160oC and 170oC. It burns with a blue flame giving off an odour of burning paraffin wax and of octyl alcohol. B. To 0.25 g add 10 ml of toluene R and boil under a reflux condenser for about 15 min. Place a few drops of the solution on a disc of sodium chloride R slide and evaporate the solvent in an oven at 80oC. Examine by infrared absorption spectrophotometry (2.2.24), comparing with the spectrum obtained with polypropylene CRS. C. To 2 g add 100 ml of water R and boil under a reflux condenser . if yes, please provide your lowest quotation to discuss further for sending the samples.