(Polyamide Suture, Sterile, in Distributor for Veterinary Use, Ph. Eur. monograph 3083)
DEFINITION
Sterile polyamide 6 suture in distributor for veterinary use is obtained by drawing through a suitable die a synthetic plastic material formed by the polymerisation of ε-caprolactam (azepan-2-one). Sterile polyamide 6/6 suture in distributor for veterinary use is obtained by drawing through a suitable die a synthetic plastic material formed by the polycondensation of hexamethylenediamine (hexane-1,6-diamine) and adipic acid (hexanedioic acid).
Blends of polyamide 6 and polyamide 6/6 are common.
Polyamide suture consists of smooth, cylindrical monofilaments or braided filaments, or lightly twisted strands sheathed with the same material, according to the diameter required. It may be coloured with colouring matter or pigments authorised by the competent authority. The suture is then sterilised.
PRODUCTION
ε-Caprolactam monomer and oligomers
(for sutures containing polyamide 6): maximum 2 per cent.
In a continuous-extraction apparatus, treat 1.00 g with 30 mL of methanol R at a rate of at least 3 extractions per hour for 7 h. Evaporate the extract to dryness, dry the residue at 110 °C for 10 min, allow to cool in a desiccator and weigh. The
residue weighs a maximum of 20 mg.
CHARACTERS
It is not attacked by dilute alkaline solutions (for example a 100 g/L solution of sodium hydroxide) but is attacked by dilute mineral acids (for example 20 g/L sulfuric acid) and by hot glacial acetic acid.
IDENTIFICATION
Infrared absorption spectrophotometry (2.2.24). Examine by attenuated total reflection (ATR).
Absorption maxima and intensities: 3296 ± 10 cm-1 (medium); 2930 ± 15 cm-1 (medium); 2862 ± 15 cm-1 (medium); 1635 ± 5 cm-1 (strong); 1539 ± 12 cm-1 (strong); 1462 ± 10 cm-1 (medium); 1262 ± 12 cm-1 (medium).
Additives and coatings of materials might lead to additional peaks.
TESTS
It complies with the tests prescribed in the monograph Strands, sterile non-absorbable, in distributor for veterinary use (0605).
STORAGE
See the monograph Strands, sterile non-absorbable, in distributor for veterinary use (0605).
LABELLING
See the monograph Strands, sterile non-absorbable, in distributor for veterinary use (0605).
The label states whether the suture is braided, monofilament or sheathed.
