| Objective:To establish quality evaluation system for quality research of cefmetazole sodium for injection.Especially the content and related substances,polymer determination,Study on stability of preparation,including factors influencing test,accelerated test and long-term test.All these provides a scientific basis for the production,packaging,storage,transport conditions and the period of validity,in order to ensure clinical safety and effectiveness of drugs.Method:Study physical properties and stability of cefmetazole sodium raw material,such as solubility,specific rotation,melting point,hygroscopicity and acidity.Because of the compound stability,content related substances and polymers are the key of control for the quality of the preparation so establish methods for determination,the methods can accurately on the three indexes.And the method have been proven.Investigation of the stability of raw materials by factors influencing test and forced degradation sotest.Effects of raw materials for main stability factors,reference Injection relevant regulations of injection in CP.Investigation the preparation,color and clarity of the appearance of solution,pH value,loss on drying.In order to effectively control the quality of injection Check;Content,related substance and polymer of the Preparation Combination Factors influencing test accelerated test,and long-term test to comprehensive research preparation stability,.Determination of the effective period and storage conditions.Result:This product is white to slightly yellow powder.Odorless or slight stinky.With a moist.Using HPLC,UV,IR and sodium flame reaction to identify.pH of value the products between 4.2?6.2.Moisture content of less than 1%,the solution is clear and colourless,visible foreign matter,sterile,insoluble particles are in line with the CP 2010 ' s relevant provisions.Determination method of related substances has been proved(include specificity,destructive testing,reproducibility,linearity,system suitability test).Show that the method has high specificity,accuracy and reliability.The test results show that:The related substances of samples single maximum impurity about 0.42%,about 1.57%?1.62%of the total impurities.Domestic and foreign varieties are not the polymer check items,This study established the determination method of polymer,Method study show the method is accurate,reproducible,the precision is good.The polymer samples in 0.03%or so.Method study(include specificity,linearity,precision,solution stability,repeatability,system suitability test),show content determination method can accurately on the preparation.According to the result,The sample in the anhydrous with cefmetazole(C15H17N7O5S3)shall not be less than 86%.According to the average load with cefmetazole(C15H17N7O5S3)should be marked volume 90?110%.This product conforms to specified.Factors affecting test results show,the sample in 60?and 40 ?,color is deepened apparently.And related substances increased significantly.The sample in RH 60%and RH 75%into a gelatinous viscous solution.And there is a lot of bubbles.At the same time related substances increased significantly,and so under glare conditions.Therefore,the samples should be sealed,leave to cool and dry place.Conclusion This product adopts glass bottle packaging after 6 months of accelerated test,12 months long term sample test,its content,polymer,visible foreign matter,sterile did not significantly change.pH decreased(4.74-4.34);increase the moisture(0.52%?0.84%).Clarity of solution and deepening the color(clarification from colorless to light in the 3 standard solution;shallow at No.1 turbidity liquid);related substances(total impurities from 1.57%?3.52%).All the indicators are in line with standards. |
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