Various pharmacopoeias regulate the quality of active pharmaceutical ingredients in detail in monographs, in particular the European Pharmacopoeia (Ph. Eur.), the International Pharmacopoeia of the WHO (Ph. Int.), the US Pharmacopoeia (USP) or the British Pharmacopoeia (BP). The latter also include monographs on finished medicinal products. InphA can offer the full range of analysis according to these monographs, almost all analytical techniques in demand are available at the institute or can be subcontracted if required. Typical tests are identity tests, purity tests and assay determinations, which are carried out in a wide variety of ways.
Screening for residual solvents
Solvents can be used during the synthesis of active ingredients and during the production of medicinal products, and these may not be removable completely from the end-product. Some of these solvents can be highly detrimental to health, which is why their use is entirely forbidden in the European Union (EU). For others, strict threshold values are in place.
The European Pharmacopoeia (Ph. Eur.) limits the amount of residual solvents in active ingredients, excipients and finished products (Ph. Eur. 5.4). The solvents are grouped into Classes 1 – 3, depending on their potential danger to health and their environmental compatibility. Class 1 contains solvents with a carcinogenic risk or a risk for the environment. Class 2 contains solvents with non-genotoxic carcinogenic toxicity and other solvents with irreversible (neurotoxic, teratogenic) and significant reversible toxicity. Solvents with low toxic potential fall into Class 3.
The method used by InphA is suitable for screening active ingredients and excipients for the presence of residues of the following solvents:
- Class 1: Benzene, 1,1-dichlorethylene, 1,2 dichlorethane, carbon tetrachloride, 1,1,1-trichlorethane,
- Class 2: Acetonitrile, chlorobenzene, chloroform, cyclohexane, cis 1,2-dichlorethene, trans 1,2-dichlorethene, dichlormethane, 1,2-dimethoxyethane, 1,4-dioxane, n-hexane, methanol, methylbutylketone (2-hexanone), methylcyclohexane, nitromethane, pyridine, tetrahydrofuran, tetralin, toluene, 1,1,2-trichlorethene, xylene.
Active ingredients and excipients.