RESUMO
Newcastle disease vaccines
Assuntos
Animais , Embrião de Galinha , Galinhas/virologia , Vírus da Doença de Newcastle/patogenicidade , Doenças das Aves Domésticas/prevenção & controle , Vacinas Atenuadas/uso terapêutico , Vacinas Virais/uso terapêutico , Técnicas de Cultura de Células , Células Cultivadas , Galinhas/imunologia , Vírus da Doença de Newcastle/classificação , Vírus da Doença de Newcastle/crescimento & desenvolvimento , Cultura Primária de Células , Doenças das Aves Domésticas/imunologia , Doenças das Aves Domésticas/virologia , Vacinação , Vacinas Atenuadas/efeitos adversos , Vacinas Atenuadas/imunologia , Vacinas Virais/efeitos adversos , Vacinas Virais/imunologiaRESUMO
GMP conditions commands to control adequately the quality of APIs by checking the levels of residual solvents. Organic solvents such as acetone, ethyl acetate, isopropyl alcohol, methanol, tetrahydrofuran and toluene frequently used in pharmaceutical industry for the manufacturing of Active Pharmaceutical ingredients [APIs]. A selective Gas Chromatographic [GC] method has been developed and validated as per ICH guidelines for residual solvent analysis in 10 different hydro chloride salts of APIs. Residual solvents in APIs were monitored using gas chromatography [GC] with Flame Ionisation detector [FID]. The separation was carried out on BP 624 column [30m X 0.53mm i.d. X 0.25micro m coating thickness], using GC 17 A shimadzu, with nitrogen as carrier gas in the split mode by direct injection method. The method described is simple, sensitive, rugged, reliable and reproducible for the quantitation of acetone, ethyl acetate, isopropyl alcohol, methanol, tetrahydrofuran and toluene at residual level from hydrochloride chloride salts of APIs