Desmopressin Acetate Synthesis Of Bulk Drugs And Quality Standard Research

Desmopressin acetate is mainly used for the treatment of hemophilia,postoperative hemostasis,central diabetes insipidus,nocturnal enuresis and so on,which has a good hemostatic effect and does not produce pressurized side effects.Desmopressin acetate is a polypeptide drug that is a structural analogue of natural arginine vasopressin,which is the deamination of 1-cysteine and the replacement of 8-L-Arginine,so this product is also known as ammonia arginine vasopressin,which is similar to the natural hormone arginine vasopressin structure.The difference between it and arginine vasopressin is mainly that of deamination of cysteine and substitution of L-arginine with D-arginine.These structural changes,the clinical dose of desmopressin to extend the role of time,without the pressure side effects.This product preparation process using conventional solid-phase synthesis method,through the study of the proposed synthetic route to explore and through small batch production and pilot production amplification test,that the synthesis of the production process is stable and feasible for mass production.Through structural confirmatory studies,the resulting raw materials proved to be consistent with the structural characteristics of desmopressin acetate.In this study,the quality standard of desmopressin acetate was studied.In this study,the methods of validation,identification,related substances,determination of residual solvents,bacterial endotoxin,trifluoroacetic acid,microorganisms,heavy metals,arsenic salts and polymers were established.This product by high temperature,high humidity,light exposure to 30 days of influencing factors test,accelerated test for 6 months and long-term test for 9 months,the inspection indicators were no significant changes.Stability test results show that the properties of this product is stable,storage conditions at 2?8?,sealed.Validity is tentative 24 months.The proposed market packaging and compatibility of this product is better,do not interact with this product.Conclusion:The desmopressin acetate developed in this paper has a stable preparation process,strict quality standards,accurate control of the quality of the product,for the preparation of production to provide stable chemical synthesis of API.At present,there is no such kind of species listed in our country.This study can better meet the needs of the majority of patients.Therefore,to declare acetic acid desmopressin has better market prospects and profit margins.