Especificaciones Técnicas: Stoppers de Goma para Meropenem en China National Medicines Guo, Monografías, Ensayos de Inglés

¡Descarga Especificaciones Técnicas: Stoppers de Goma para Meropenem en China National Medicines Guo y más Monografías, Ensayos en PDF de Inglés solo en Docsity! China National Medicines Guorui Pharmaceutical Co., Ltd Chaoyang East Road, Huainan City,Anhui Province(Huainan Economic and Tecnological Development Zone) TECHNICALSPECIFICACIONOFLEAFLET Name of the raw material: Rubber stoppers to Meropenem for injection Page N“:1 of1 0.Sg Reference: In house EffectiveDate:2021/01/01 Specification of Rubber stoppers — In house Test items Specification Appearance It should be clean, smooth, uniform, and having no pinholes or punctures Size Neck Diameter: 13.0£0.1mm Cap Diameter: 19.50.2mm Cap Thickness: 3.040.25mm Total height:8.740.3mm Identification It should produce white or yellowish precipitate Itis uniform with the reference spectrum Puncture chip Not more than $ pieces Puncture force Not more than 10N Suitability of stopper and vial The solution of methylene blue should not infiltrate into the vials Self-airtightness test The solution of methylene blue should not infiltrate into the vials Ash Not more than 50% Volatile Sulfide Meet the requirements Particular matter =104m, <60 >25m, <6 Color and clarity of solution NMT turbid than reference suspension II, NMT intensely colored than reference solution GYs pH Difference between the two should be not more than 1.0 UV absorbance The maximum absorbance at 220-360nm is not more than 0.2 Non-volatile matter Not more than 4.0mg Readily oxidizable substance Not more than 7.0m1 Heavy metal Not more than Ippm Ammonium <0.0002% ReviewDate:2021/01/01