Analysis of materials | Pharmaceutical analyses
Polyolefins are obtained by polymerisation of ethylene or propylene or by copolymerisation of these substances with not more than 25 per cent of higher homologues (C4 to C10) or of carboxylic acids or of esters. Certain materials may be mixtures of polyolefins.
Polypropylene consists of the homopolymer of propylene or of a copolymer of propylene with not more than 25 per cent of ethylene or of a mixture (alloy) of polypropylene with not more than 25 per cent of polyethylene. It may contain additives.
Poly(ethylene - vinyl acetate), complying with the following requirements, is suitable for the manufacture of containers and tubing for total parenteral nutrition preparations. It is obtained by copolymerisation of mixtures of ethylene and vinyl acetate.
Silicone oil used as a lubricant is a poly(dimethylsiloxane) obtained by hydrolysis and polycondensation of dichlorodimethylsilane and chlorotrimethylsilane. Different grades exist which are characterised by a number indicating the nominal viscosity placed after the name.
ilicone elastomer complying with the following requirements is suitable for the manufacture of closures and tubing. Silicone elastomer is obtained by cross-linking a linear polysiloxane constructed mainly of dimethylsiloxy units with small quantities of methylvinylsiloxy groups; the chain ends are blocked by trimethylsiloxy or dimethylvinylsiloxy groups.
Materials based on non-plasticised poly(vinyl chloride) that comply with the following specifications are suitable for the manufacture of containers for non-injectable aqueous solutions. They may also be used for solid forms for oral administration and in some cases, subject to special studies on the compatibility of the container with its contents, these materials may be suitable for the preparation of containers for suppositories. They consist of 1 or more poly(vinyl chloride/vinyl acetate) or of a mixture of poly(vinyl chloride) and poly(vinyl acetate) or of poly(vinyl chloride).
Materials based on non-plasticised poly(vinyl chloride) for containers for solid dosage forms for oral administration are suitable for the manufacture of sheets or containers, and consist of 1 or more poly(vinyl chloride/vinyl acetate) or of a mixture of poly(vinyl chloride) and poly(vinyl acetate) or of poly(vinyl chloride).
Materials based on plasticised poly(vinyl chloride) contain not less than 55 per cent of poly(vinyl chloride) and contain various additives, in addition to the high-molecular-mass polymer obtained by polymerisation of vinyl chloride.
Polyethylene terephthalate is obtained from the polymerisation of terephthalic acid or dimethyl terephthalate with ethylene glycol. Isophthalic acid, dimethyl isophthalate, 1,4-bis(hydroxymethyl)cyclohexane (cyclohexane-1,4-dimethanol) or diethylene glycol may be used in the polymerisation. It may contain not more than 0.5 per cent of silica or silicates and colouring matter approved by the competent authority.