INSULIN INJECTION, ISOPHANE - uspbpep.com

1 EUROPEAN PHARMACOPOEIA lispro01/2008:0833corrected injection , ISOPHANEI nsulinum isophanum iniectabileIsophane INSULIN injection complies with the monographon INSULIN preparations, injectable (0854) with themodifications prescribed INSULIN injection is a sterile suspension of bovine,porcine or human INSULIN , complexed with protaminesulphate or another suitable INSULIN injection is prepared by carrying outthe procedures described in the monograph onInsulinpreparations, injectable (0854).The amount of protamine is based on the known isophaneratio and is not less than the equivalent of mg and notmore than the equivalent of mg of protamine sulphatefor each 100 IU of INSULIN in the INSULIN -protamine white or almost white suspension which on standingdeposits a white or almost white sediment and leaves acolourless or almost colourless supernatant liquid; thesediment is readily resuspended by gently shaking.

2 Whenexamined under a microscope, the particles are seen to berod-shaped crystals, the majority with a maximum dimensiongreater than 1 m but rarely exceeding 60 m, free fromlarge the chromatograms obtained in the Assay. Theposition of the peak due to INSULIN in the chromatogramobtained with the test solution corresponds to that of theprincipal peak in the chromatogram obtained with theappropriate reference zinc. Not more than g per 100 IU of INSULIN ,determined as described in the monograph onInsulinpreparations, injectable (0854).01/2008:0834 INSULIN injection , SOLUBLEI nsulinum solubile iniectabileSoluble INSULIN injection complies with the monographon INSULIN preparations, injectable (0854) with theamendments prescribed INSULIN injection is a neutral, sterile solution ofbovine, porcine or human colourless liquid, free from turbidity and foreign matter;during storage, traces of a very fine sediment may the chromatograms obtained in the assay.

3 Theposition of the peak due to INSULIN in the chromatogramobtained with the test solution corresponds to that of theprincipal peak obtained with the appropriate zinc. Not more than g per 100 IU of by the method described in the monograph onInsulin preparations, injectable (0854).Use the following test containing 200 IU to ml withwater if necessary to a suitable concentration (for example, g to g of Zn per millilitre) withwater :2085corrected LISPROI nsulinum lisprumC257H383N65O77S6Mr5808 DEFINITION28B-L-Lysine-29B-L-proline INSULIN (human). A-chain is composed of 21 amino acids and the B-chainis composed of 30 amino acids.

4 It is identical in primarystructure to human INSULIN , only differing in amino acidsequence at positions 28 and 29 of the B-chain. Humaninsulin is Pro(B28), Lys(B29), whereas INSULIN lispro isLys(B28), Pro(B29). As in human INSULIN , INSULIN lisprocontains 2 interchain disulphide bonds and 1 intrachaindisulphide : per cent to per cent (dried substance).By convention, for the purpose of labelling INSULIN lispropreparations, mg of INSULIN lispro is equivalent lispro is produced by a method based on recombinantDNA (rDNA) technology under conditions designed tominimise the degree of microbial to release the following tests are carried out on eachbatch of final bulk product, unless exemption has beengranted by the competent proteins.

5 The limit is approved by thecompetent precursor. The limit is approved by thecompetent authority. Use a suitably sensitive (1)applytoallmonographsandothertexts2141