impurities – Diduco

Ion chromatography

Published case study of analytical quality by design method development and validation

Diduco has published a scientific peer-reviewed case study on how modern analytical method development can be performed in the pharmaceutical industry. The work was performed according to quality by design (QbD) principles to establish the design space and robust setpoint of the ion chromatography assay, and then validated according to the guidelines established by the International Council for Harmonization (ICH).

Ion chromatography

Screening of contaminants and forced degradation products in lithium ion battery electrolyte

Electrolytes in rechargeable batteries for cars, mobile phones, and other portable electric devices typically contain negatively charged counterions that together with lithium and a non-aqueous solvent form an ionic liquid. The bis(fluorosulfonyl)imide anion is a rather new ionic liquid constituent which thus need new quality control procedures.

Ion chromatography

Determination of sulfamate and sulfate in topiramate tablets according to USP monograph

Official quality control method for the second-generation antiepileptic drug topiramate which also have shown effect against migranes. This analysis was performed according to the United States Pharmacopeia monograph and determines the degradation products sulfamate and sulfate which can be formed during storage in humid environments or at elevated temperatures.

Ion-exclusion chromatography

Separation of organic acids by ion-exclusion chromatography

Separation of organic acids can be a challenging task due to their hydrophilic nature and structural diversity. One of the more traditional approaches to this analysis is ion exclusion chromatography, which offer complementary selectivity to other separation techniques, especially for the monovalent acids which tend to be more strongly retained in this mode.

Ion chromatography

Analysis of clodronate related substances according to European Pharmacopoeia monograph

Official quality control method for the first-generation bisphosphonate clodronate, which inhibits bone resorption and is used to treat bone weakness or pain caused by cancer that has spread to the skeleton. This analysis was performed according to the European Pharmacopoeia monograph method which is used to determine related substances that could be present as impurities in the active ingredient.

Alternative method for voriconazole impurity E

Ion chromatography

Alternative method for determination of voriconazole impurity E

Voriconazole is an antifungal medication that is included on the WHO Model list of Essential Medicines. During synthesis of the active ingredient a resolving agent for chiral amines is often used, and it is thus necessary that the quality control prove that this substance is not present at harmful levels in the final product.

Keyword: impurities

Applications

Published case study of analytical quality by design method development and validation

Screening of contaminants and forced degradation products in lithium ion battery electrolyte

Determination of sulfamate and sulfate in topiramate tablets according to USP monograph

Separation of organic acids by ion-exclusion chromatography

Analysis of clodronate related substances according to European Pharmacopoeia monograph

Alternative method for determination of voriconazole impurity E

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