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Feasibility and Extension of Universal Quantitative Models for Moisture Content Determination in Beta-Lactam Powder Injections by Near-Infrared Spectroscopy

Feasibility and Extension of Universal Quantitative Models for Moisture Content Determination in Beta-Lactam Powder Injections by Near-Infrared Spectroscopy

Xue-Bo Zhang, Yan-Chun Feng, Chang-Qin Hu

Anal Chim Acta. 2008 Dec 23;630(2):131-40.

PMID: 19012824

Abstract:

In present work, we investigated the feasibility of universal calibration models for moisture content determination of a much complicated products system of powder injections to simulate the process of building universal models for drug preparations with same INN (International Nonproprietary Name) from diverse formulations and sources. We also extended the applicability of universal model by model updating and calibration transfer. Firstly, a moisture content quantitative model for ceftriaxone sodium for injection was developed, the results show that calibration model established for products of some manufacturers is also available for the products of others. Then, we further constructed a multiplex calibration model for seven cephalosporins for injection ranging from 0.40 to 9.90%, yielding RMSECV and RMSEP of 0.283 and 0.261, respectively. However, this multiplex model could not predict samples of another cephalosporin (ceftezole sodium) and one penicillins (penicillin G procaine) for injection accurately. With regard to such limits and the extension of universal models, two solutions are proposed: model updating (MU) and calibration transfer. Overall, model updating is a robust method for the analytical problem under consideration. When timely model updating is impractical, piecewise direct standardization (PDS) algorithm is more desirable and applied to transfer calibration model between different powder injections. Both two solutions have proven to be effective to extend the applicability of original universal models for the new products emerging.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP41136225	Ceftezole Sodium		41136-22-5	Price

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