Estudios de estabilidad en tiempo real de Meropenem inyección 500mg, Monografías, Ensayos de Inglés

¡Descarga Estudios de estabilidad en tiempo real de Meropenem inyección 500mg 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) Real Time Stability Studies Generic name: Meropenem for injection 500mg Name and country of the Manufacturer: China National Medicines Guorui Pharmaceutical Co., ltd Name andcountry of the laboratory that performs this stability study: Chaoyang East Road,Huainan City, Anhui Province(Huainan Economic and technological Development Zone) Each vial content: Quality-Quantitative Formula Generic Meropenem for injection 500Ómg Name Specificat | USP 43 ion Dosage 500mg/vials form Compositi | Each vial per 500mg contains Standard Function Concentration on Active 1 USP 43 Active 500mg Pharmace . Ingredient . Meropenem utical Ingredient Excipients | 1 | Sodium Carbonate USP 43 Excipients | 104g Excipients | 2 | Sodium USP 43 Excipients | q.s Storage condition: Temperature: 30+2*”Crelativehumidity:65%:+5%. a A. Batch type , Strength | Batenno | Manufacturing | Expiring_ | Batch (pito: Sample quantity date date size z 4 orindustrial) 101121 Nov2010 Nov 2013 50000 Industrial 1000 500mg 101122 Nov 2010 Nov. 2013 50000 Industrial 1000 101123 Nov.2010 Nov. 2013 50000 Industrial 1000 Shelf life of the product is 36months. China National Medicines Guorui Pharmaceutical Co., Ltd Chaoyang East Road,Huainan City,Anhui Province(Huainan Economic and Tecnological Development Zone) Storage condition of the finished product: Store at temperature not greater than 30*C. QAmanager: * HR LinXingChen China National Medicines Guorui Pharmaceutical Co., Ltd Chaoyang East Road,Huainan City,Anhui Province(Huainan Economic and Tecnological Development Zone) of the Meropenem dimer, with a relative retention time of 1.9. -Not more than 0.10% of any induvial unspecified impurity -Not more than 1.0 of total unspecified impurities. -Not more than 2.0 of total impurities. 10 80%-120% of the 99.9% 99.9% 99.6% 99.5% 99.9% 99.9% 99.9% Content of . labeled amount of 105% sodium . sodium 1 pH 7.3-8.3 EXU 8.0 8.0 8.0 8.0 8.0 8.0 8.0 12 Loss on drying | 9.0%-12.0% 10.2% 9.9 9.9 9.9 9.9 9.9 9.9 9.9 13 Assay content 90.0%-120.0% 99.9% 110. 101.0 110. 101.0 110. 101.0 110. of Meropenem Conclusion: No significant changes observed to 36 months at real time condition and is stable at 30%C + 2%and 65% + 5% Relative Humidity. China National Medicines Guorui Pharmaceutical Co., Ltd Chaoyang East Road,Huainan City,Anhui Province(Huainan Economic and Tecnological Development Zone) REAL TIMESTABILITYANALYSIS emperature: 30%C + 2*C and Name Product: Meropenem for injection 500mg Storage Condition: | Relative Humidity: 65% + 5% RH Batch N*:111022 Manufacturing Date: Oct 2011 Expiry Date: Oct 2014 Batch Type: Industrial Batch of rawmaterial: 10121662 BatchSize:50000 Start Date: Oct 2011 Study end date: Oct 2015 Reference: USP 43 SampleSize: 1000 packing: vials Tests Specification Frequency e 3 6 18 24 Initial month months 9months 12months months months 36months Description b) White or light Complies | Comply Comply Comply Comply Comply Comply Comply c) Before of yellow crystalline Constituted powder. . d) After of b) Colorless or light Constituted yellow clear liquid A. The retention time | Complies | Comply | Comply | Comply Comply Comply |Comply | Comply of the meropenem peak of the Sample solution corresponds to that of the Standard solution, as obtained Identification in the Assay. B. The UV spectrum of the major peak of the Sample solution corresponds to that of the Standard China National Medicines Guorui Pharmaceutical Co., Ltd Chaoyang East Road,Huainan City,Anhui Province(Huainan Economic and Tecnological Development Zone) solution, as obtained in the Assay. a relative retention time of 1.0. At the time of use, it Complies | Complies | Complies | Complies | Complies Complies | Complies | Complies meets the requirements | Complies | Complies | Complies | Complies | Complies Complies | Complies | Complies for Injections and Implanted Drug Constituted Products<1>, Product solution Quality Tests Common to Parenteral Dosage Forms, Specific Tests, Completeness and clarity of solutions. Bacterial Complies | Complies | Complies | Complies | Complies Complies | Complies | Complies endotoxins Meet the requirements Test Sterility Test Meet the requirements | Complies | Complies | Complies | Complies | Complies Complies | Complies | Complies Uniformity % laV<LI%(Li=15) 2.9 29 29 29 29 29 29 2.9 losage units Average weight | 655.975-725.025mg 685.60mg | 685.60mg | 685.60mg | 685.60mg | 685.60mg 685.60mg | 685.60mg | 685.60mg D 0;0 y 00 K) 0;0 L) 0;0 M) 0;0 N) 0;0 O) 0:0 P) 0;0 Particles matter Meets the requirements | Free from | Free from | Free from | Free from | Free from | Free from | Free from | Free from in injection: for small-volume particles | particles | particles | particles of | particles of | particles | particles | particles of : injections of foreign | of foreign | of foreign | foreign foreign of foreign | of foreign | foreign matter matter matter matter matter matter matter matter ee 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% open rines, witha Complies | Complies | Complies | Complies | Complies Complies | Complies | Complies : Po 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% Organic relative retention time | (pp, 0.0% 0.0% [0.0% 0.0% 0.0% 0.0% 0.0% impurity of 0.45. «0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% “The meropenem with [ 7, 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% China National Medicines Guorui Pharmaceutical Co., Ltd Chaoyang East Road,Huainan City,Anhui Province(Huainan Economic and Tecnological Development Zone) time of 1.0. -Not more than 0.6% of the Meropenem Assay. At the time of use, it Complies | Complies | Complies | Complies | Complies Complies | Complies | Complies meets the requirements | Complies | Complies | Complies | Complies | Complies Complies | Complies | Complies for Injections and Implanted Drug Constituted Products<1>, Product solution Quality Tests Common to Parenteral Dosage Forms, Specific Tests, Completeness and clarity of solutions. Bacterial Complies | Complies | Complies | Complies | Complies Complies | Complies | Complies endotoxins Meet the requirements Test Sterility Test Meet the requirements | Complies | Complies | Complies | Complies | Complies Complies | Complies | Complies tormity %laVSLIó(LI=15) 2.9 29 29 29 29 29 29 29 losage units Average weight | 655.975-725.025mg 685.60mg | 685.60mg | 685.60mg | 685.60mg | 685.60mg 685.60mg | 685.60mg | 685.60mg Q) 0;0 R) 0;0 S) 0;0 T) 0;0 U) 0;0 v) 0;0 W) 0;0 X) 0;0 4 Meets the requirements | Free from | Free from | Free from | Free from | Free from | Free from | Free from | Free from Particles matter . . : : . . : . in injection: for small-volume particles particles particles particles of particles of particles particles particles of injections of foreign | of foreign | of foreign | foreign foreign of foreign | of foreign | foreign matter matter matter matter matter matter matter matter -Not more than 0.8% o open 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 5 ve orion time Complies | Complies | Complies | Complies | Complies Complies | Complies | Complies Organic 00.45. 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% impurit -The meropenem with 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% punty IC IrONCIAOE: 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% a relative retention 0.1% 0.1% 0.1% [0.1% 0.1% 0.1% 0.1% 0.1% China National Medicines Guorui Pharmaceutical Co., Ltd Chaoyang East Road,Huainan City,Anhui Province(Huainan Economic and Tecnological Development Zone) dimer, with a relative retention time of 1.9. -Not more than 0.10% of any induvial unspecified impurity -Not more than 1.0 of total unspecified impurities. -Not more than 2.0 of total impurities. 10 Content £ 80%-120% of the 99.9% 99.9% 99.6% 99.5% 99.9% 99.9% 99.9% onren 0% | tabeled amount of 105% sodium . sodium 11 pH 7.3-8.3 8.0 8.0 8.0 8.0 8.0 8.0 8.0 8.0 12 Loss on drying | 9.0%-12.0% 10.2% 9.9 9.9 9.9 9.9 9.9 9.9 9.9 13 Assay content 90.0%-120.0% 99.9% 110. 101.0 110. 101.0 110. 101.0 110. of Meropenem Conclusion: No significant changes observed to 36 months at real time condition and is stable at 30C + 2%and 65% + 5% Relative Humidity. China National Medicines Guorui Pharmaceutical Co., Ltd Chaoyang East Road,Huainan City,Anhui Province(Huainan Economic and Tecnological Development Zone) Conclusion: According to the stability studies under normal test conditions: we could make a conclusion that the finished product is stable and its packing form is suitable, also the shelf-life of the finished product is recommended to beat least 3 years under routine storage condition. Approved by: Qp: GuMa