Quality control of ferrous sulphate tablets and oral solutions used on the iron-deficiency anaemia
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Keywords

iron-deficiency anaemia
ferrous sulphate
oral solution
tablets
quality control

How to Cite

1.
Arcon Batistic M, Tirico Auricchio M, Elena Ortega Markman B. Quality control of ferrous sulphate tablets and oral solutions used on the iron-deficiency anaemia. Rev Inst Adolfo Lutz [Internet]. 1998 Jun. 30 [cited 2024 Jul. 22];57(1):25-8. Available from: https://periodicos.saude.sp.gov.br/RIAL/article/view/36617

Abstract

In order to control the quality of some phannaceutical preparations containing ferrous sulphatc uscíul to prevent iron-deficiency in infants, children and young women, 41 samples were analysed. Those samples were presented in two dosage forms, such as oral solutions and tablets. he test results showed that 15(37%) samples didn't mect the requeriments of the oficial monographies anyway From thosc not compliant sarnples, sevendidn't mectthc requerimentfor the statedconcentration of ferrous sulphate andlor ascorbic acid, four didn't meet the requirements for stability and Iour didn't mect the requirements for labcl. Problems with precipitations in the liquids dosagc fonns and crackings in
the tablets are dicussed. Quality control programs have to be established to moni torate the drugs listed as essential drugs in Brasil.

https://doi.org/10.53393/rial.1998.57.36617
pdf (Português (Brasil))

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Copyright (c) 1998 Instituto Adolfo Lutz Journal

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