Reference standards (RS) are highly characterized substances which are specifically required in pharmacopoeial tests and assays. Quality control testing of human insulin is performed using the methods given in the Indian Pharmacopoeia (IP) monograph which requires the use of human insulin RS. However, there was no RS available to support the IP monograph on human insulin. Therefore, National Institute of Biologicals undertook a collaborative study to establish the first National human insulin RS. The methods selected to qualify the candidate material were those included in the IP monograph on human insulin. The study was defined to calibrate the candidate by liquid chromatography in terms of International primary standard i.e. human insulin Ph. Eur. RS and to assign a unit age. The collaborative study involved four laboratories from India, including one regulatory lab and three laboratories of insulin manufacturers. It was demonstrated that candidate material is appropriate for use as an RS in the context of human insulin according to IP monograph. Direct calibration of candidate human insulin RS was established on 26th August, 2010 with assigned potency value of 27.5 IU per mg on as-is basis and it is intended to be used in identification and assays.
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