04/2013:2034
EP 7.5
SUBSTANCES FOR PHARMACEUTICAL USE
什么是bsc药用物质
DEFINITION 定义
Substances for pharmaceutical u are any organic or inorganic substances that are ud as active substances or excipients for the production of medicinal products for human or veterinary u. They may be obtained from natural sources or produced by extraction from raw materials, fermentation or synthesis.
pudong airport药用物质是指人用或兽用医疗产品生产中所使用的活性物质或辅料，其可能是有机的或无机的物质。这些物质可能是从自然途径获取，或从原料中萃取、发酵或合成得到。
tip of your tongueThis general monograph does not apply to herbal drugs, herbal drugs for homoeopathic pre
parations, herbal drug preparations, extracts, or mother tinctures for homoeopathic preparations, which are the subject of parate general monographs (Herbal drugs (1433), Herbal drugs for homoegopathic preparations (2045), Herbal drug preparations (1434), Extracts (0765), Mother tinctures for homoeopathic preparations (2029)). It does not apply to raw materials for homoeopathic preparations, except where there is an individual monograph for the substance in the non-homoeopathic part of the Pharmacopoeia.
四六级作弊
本通论不适用于草药制品、顺势疗法制剂用草药、草药制剂、提取物、或顺势闻法制剂的药酒母体，这些品种应参照各自的各论（草药制品（1433）、顺势疗法制剂用草药（2045）、草药制剂（1434）、提取物（0765）、或顺势闻法制剂的药酒母体（2029））。也不适用于顺势疗法制剂用的原料，除非在药典的非顺势疗法部分另有各论。
Where a substance for pharmaceutical u not described in an individual monograph of the Pharmacopoeia is ud in a medicinal product prepared for the special needs of indivi
dual patients, the need for compliance with the prent general monograph is decided in the light of a risk asssment that takes account of the available quality of the substance and its intended u.
如果某种药用物质在药典里没有各论，这种物质用于满足个别病人的特殊需求的医疗产品制备，则应该考虑可以获得的该物质的质量及其用途，基于风险评估来决定该药用物质需符合的相关总论要求，且该物质应满足这些要求。
Where medicinal products are manufactured using substances for pharmaceutical u of human or animal origin, the requirements of chapter 5.1.7. Viral safety apply.
如果药品生产中使用的药用物质是人类或动物来源，则需要满足中国高校外语慕课平台5.1.7病毒安全性的要求
Substances for pharmaceutical u may be ud as such or as starting materials for subquent formulation to prepare medicinal products. Depending on the formulation, certain substances may be ud either as active substances or as excipients. Solid substances may be compacted, coated, granulated, powdered to a certain fineness, or pr
ocess in other ways. A monograph is applicable to a substance procesd with an excipient only where such processing is mentioned in the definition ction of the monograph.
药用物质可能会直接使用，或用作药用产品生产的原料。根据剂型不同，特定的物质可能会用作活性物质，或用作辅料。固体物质可能会被压制、涂层、整粒、磨粉至特定细度，或经过其它形式的加工。只有当某加工在各论定义部分被提及时，该各论方适用于与辅料一起加工的物质。
Substance for pharmaceutical u of special grade. Unless otherwi indicated or restricted in the individual monographs, a substance for pharmaceutical u is intended for human and veterinary u, and is of appropriate quality for the manufacture of all dosage forms in which it can be ud.
特殊规格药用物质。除另有说明，或在各论中有限制外，药用物质适用于人兽通用，具备的品质可以用于使用该药用物质的所有制剂形式。
Polymorphism. Individual monographs do not usually specify crystalline or amorphous forms, unless bioavailability is affected. All forms of a substance for pharmaceutical u comply with the requirements of the monograph, unless otherwi indicated.
多晶型。除非对生物利用度会造成影响，各论中通常不说明晶形或非晶型形态。除非另有说明，物质的所有形态均符合各论的要求。
PRODUCTION 生产
Substances for pharmaceutical u are manufactured by procedures that are designed to ensure a consistent quality and comply with the requirements of the individual monograph or approved specification.
药用物质应根据程序进行生产，
The manufacture of active substances must take place under conditions of good manufacturing practice.
活性物质的生产应在GMP条件下进行。
The provisions of general chapter 5.10 apply to the control of impurities in substances for pharmaceutical u.
总论5.10适用于药用物质中的杂质控制。
neutralization
Whether or not it is specifically stated in the individual monograph that the substance for pharmaceutical u:
无论在各论中是否申明为药用，该药用物质
拿下马来— Is a recombinant protein or another substance obtained as a direct gene product bad on genetic modification, where applicable, the substance also complies with the requirements of general monograph Products of recombinant DNA technology (0784);
— 如果是重组蛋白质或另一物质为基于基因修饰的直接基因产品，适当时，该物质应符合通论0784重组DNA技术产品要求
— 幼师培训班Is obtained from animals susceptible to transmissible spongiform encephalopathies
other than by experimental challenge, where applicable, the substance also complies with the requirements of the general monograph Products with risk of transmitting agents of animal spongiform encephalopathies (1483);五月的英文
—mortal什么意思 如果是动物来源物质，可能会有TSE风险，适用时，该物质还应符合通论1483具有TSE风险的产品要求
