Recent trends in the impurity profile of pharmaceuticals

Abstract

Various regulatory authorities such as the International Conference on Harmonization (ICH), the United States Food and Drug administration (FDA), and the Canadian Drug and Health Agency (CDHA) are emphasizing on the purity requirements and the identification of impurities in Active Pharmaceutical Ingredients (APIs). The various sources of impurity in pharmaceutical products are — reagents, heavy metals, ligands, catalysts, other materials like filter aids, charcoal, and the like, degraded end products obtained during \ after manufacturing of bulk drugs from hydrolysis, photolytic cleavage, oxidative degradation, decarboxylation, enantiomeric impurity, and so on. The different pharmacopoeias such as the British Pharmacopoeia, United State Pharmacopoeia, and Indian Pharmacopoeia are slowly incorporating limits to allowable levels of impurities present in APIs or formulations. Various methods are used to isolate and characterize impurities in pharmaceuticals, such as, capillary electrophoresis, electron paramagnetic resonance, gas–liquid chromatography, gravimetric analysis, high performance liquid chromatography, solid-phase extraction methods, liquid–liquid extraction method, Ultraviolet Spectrometry, infrared spectroscopy, supercritical fluid extraction column chromatography, mass spectrometry, Nuclear magnetic resonance (NMR) spectroscopy, and RAMAN spectroscopy. Among all hyphenated techniques, the most exploited techniques for impurity profiling of drugs are Liquid Chromatography (LC)-Mass Spectroscopy (MS), LC-NMR, LC-NMR-MS, GC-MS, and LC-MS. This reveals the need and scope of impurity profiling of drugs in pharmaceutical research.

Photocurable Bioink for the Inkjet 3D Pharming of Hydrophilic Drugs

“…The abundant norbornene groups in the HA backbone react with PEGDT in the presence of visible light (120 mW/cm 2 ), forming multiple crosslinks through a light induced step-growth polymerization reaction ( Figure 1 B). Visible light represents a safer light source than UV light to be used for the operation of printing equipment and to maintain the stability of certain UV light labile APIs [ 23 ].…”

Stability of Hydrocortisone in Oral Powder Form Compounded for Pediatric Patients in Japan

“…Hydrocortisone (target substance, purity > 99.0%) was purchased from Tokyo Chemical Industry (Tokyo, Japan). Impurities of hydrocortisone were procured from Sigma-Aldrich (Tokyo, Japan) as follows: prednisolone (impurity A), cortisone (impurity B), hydrocortisone acetate (impurity C), 6β-hydroxy-hydrocortisone (impurity D), 6-dehydrocortisol (impurity E), Reichstein substance S (impurity F), hydrocortisone-21-aldehyde (impurity G), 7α-hydroxy-hydrocortisone (impurity H), 14α-hydroxy-hydrocortisone (impurity I), and hydrocortisone dimer (impurity N) [ 16 , 17 , 18 , 19 ] ( Figure 1 ). Lactose monohydrate (extra-fine crystal lactose hydrate “Hoei”, Pfizer, Tokyo, Japan) was used as a diluting agent.…”

Validation of the ICP-MS Method for Determination of Trace Elements Provided by ICH Q3D Guideline in Fosamprenavir Calcium

“…Therefore, it is highly expected that traces of metals will appear in pharmaceutical products. 2,3 Metals present in the active pharmaceutical ingredient (API) are of great concern due to the possible toxicity of the metals present in the product, which could put human health at high risk. 4 Elemental impurities control is a segment of pharmaceutical quality control, which ensures that elemental impurities stay within the permitted daily exposure (PDE) limits for specific pharmaceutical product.…”