Is it possible that USP will consider setting standards for residual solvents in packaging components?
USP是否可能考虑设定包材中残留溶剂的标准?
Inorganic impurities and residual solvents should also be addressed.
无机杂质和溶剂的残留,也应该被提到。
The popularity of this technique has grown over recent years and has now gained worldwide acceptance for analyses of alcohols in blood and residual solvents in pharmaceutical products.
这项技术的普及已经增长了近几年已获得了在血液中的酒精和药物残留溶剂分析全世界所接受。
Conclusion: This method has been successfully used for the detection of residual acetonitrile and toluene as organic solvents in fluvoxamine.
结论:本方法可应用于测定马来酸氟伏沙明中有机溶剂乙腈与甲苯的残留量。
Drug products should contain no higher levels of residual solvents than can be supported by safety data.
残留溶剂的量不应该高于安全性数据支持的量。
Residual solvents in active substances, excipients, and in medicinal products are within the scope of this guideline.
因此,检测应该针对在生产和纯化过程中使用到的溶剂。
Residual solvents in packaging are not addressed by this chapter.
本章中未说明包材中残留溶剂情况。
RESULTS This kind of patch has good surface quality, proper adhesive ability, low-level organic solvents residual volume and higher release speed.
结果所研制的中药浸膏压敏胶贴片外观均一,黏附性良好,残留有机溶剂含量低,测试的药物有效成分的体外释放速率高于橡皮膏。
To found a method to detect the residual solvents of penicillin sodium for injection: butanol acetic ether and butyl acetate.
摘要目的:建立一种气相色谱法同时测定注射用青霉素钠中有机溶剂丁醇、乙酸乙酯、乙酸丁酯残留量的方法。
The assay of residual solvents were calculated according to the external standard method.
通过外标法计算残留溶剂的含量。
The objective of this guideline is to recommend acceptable amounts of residual solvents in pharmaceuticals for the safety of the patient.
这篇指南的目的是为了病人的安全而推荐中残留溶剂的合理用量。
Higher levels of residual solvents may be acceptable in certain cases such as short term (30 days or less) or topical application.
高水平的残余溶剂量在下列情况下是可以接受的:短期(小于30天)或局部滴旋。
Medicinal products should contain no higher levels of residual solvents than can be supported by safety data.
药品中含有的残留溶剂必定不能高于安全数据的要求。
OBJECTIVE To determine the contents of residual volatile organic solvents, chloroform, in cordyceps Polysaccharide liposomes oral liquid.
目的:测定冬虫夏草多糖脂质体口服液中有机溶剂氯仿残留量。
By using gas chromatography residual organic solvents were determined in 22 batch Numbers of ampicillin sodium produced by 7 pharmaceutical factories of our country.
本文用气相色谱法考察测定了全国7个生产厂家22个批号的氨苄青霉素钠的有机溶媒残留量。
OBJECTIVE to establish a capillary gas chromatography method for the determination of residual organic solvents in organometallic antitumor crude drug titanocene dichloride.
目的建立毛细管气相色谱法测定有机金属抗癌原料药二氯二茂钛中的有机溶剂残留量。
Conclusion: the method is simple, rapid and of high sensitivity, it is an available method for the determination of residual organic solvents in Ginkgo Biloba leaves extract.
结论:该方法简便快速,灵敏度高,可作为银杏叶提取物中有机溶剂残留量的测定方法。
This paper reports the text on the validation of determining procedures of these residual solvents in adefovir dipivoxil.
本文对检测阿德福韦双匹酯甲醇、乙腈和醋酸异丙酯残留量的方法学进行了研究。
The method was simple, accurate and sensitive with good reproducibility. It can be used for the determination of the residual organic solvents in nucleoside medications.
本方法简单、准确、灵敏高,重现性好,适用于核苷类药物中有机溶剂残留量的测定。
A capillary GC method with FID detector for the determination of residual organic solvents ethanol, isopropanol, dichloromethane, n-hexane, tetrahydrofuran, DMF and dimethyl malonate was established.
建立了毛细管气相色谱法测定甲磺酸齐拉西酮中残留溶剂乙醇、异丙醇、二氯甲烷、正己烷、四氢呋喃、D MF、丙二酸二甲酯的残留量。
Therefore, testing should be performed for residual solvents when production or purification processes are known to result in the presence of such solvents.
只需要检测在合成或纯化药物有效成分、赋形剂和医药产品的过程中使用或产生的溶剂。
Objective If the presence of residual solvents in pharmaceuticals exceeds tolerance limits as suggested by safety data, they may be harmful to the human body or the environment.
当药品中所含的残留溶剂水平高于安全值时,残留溶剂对人体或环境将产生危害。
The residual and migration of solvents in the retort pouch after high-temperature sterilization were reduced by changing solvents.
通过改换溶剂减少了高温杀菌后蒸煮袋材料的溶剂残留及迁移。
The results showed this method would be suitable for determining several residual solvents and quality control of sertraline hydrochloride.
该法能分离多种有机溶剂,可以作为质量检查方法。
Conclusion the methodology appeared to be simple, accurate and efficient, and can be used for the determination of the residual organic volatile solvents of block cream.
结论该方法简单、准确、快捷,适用于测定防晒霜中有机溶剂残留量。
The guideline recommends the use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents.
此指南推荐使用低毒性溶剂,并且描述了一些溶剂人体能够接受的毒性水平。
The residual solvents in bicalutamide substance were determined by GC.
采用气相色谱法测定比卡鲁胺原料药中有机溶剂残留量。
Objective: to found a method to detect the residual solvents of Penicillin Sodium for Injection: butanol, acetic ether and butyl acetate.
前言:目的:建立一种气相色谱法同时测定注射用青霉素钠中有机溶剂丁醇、乙酸乙酯、乙酸丁酯残留量的方法。
Objective: to found a method to detect the residual solvents of Penicillin Sodium for Injection: butanol, acetic ether and butyl acetate.
前言:目的:建立一种气相色谱法同时测定注射用青霉素钠中有机溶剂丁醇、乙酸乙酯、乙酸丁酯残留量的方法。
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