24小时热门版块排行榜

返回列表

lx李欣

新虫 (初入文坛)

应助: 1 (幼儿园)
金币: 3.1
散金: 5
帖子: 10
在线: 14.9小时
虫号: 3138339
注册: 2014-04-15
性别: MM
专业: 环境微生物学

[求助] 求助美国药典38，Factor IX Complex 3434的标准已有2人参与

求助美国药典38，Factor IX Complex 3434的标准。

回复此楼

» 猜你喜欢

基金申报已经有5人回复
基金委咋了？2026年的指南还没有出来？已经有7人回复
国自然申请面上模板最新2026版出了吗？已经有17人回复
纳米粒子粒径的测量已经有8人回复
疑惑？已经有5人回复
计算机、0854电子信息（085401-058412）调剂已经有5人回复
Materials Today Chemistry审稿周期已经有5人回复
溴的反应液脱色已经有7人回复
推荐一本书已经有12人回复
常年博士招收(双一流，工科) 已经有4人回复

1楼 2015-09-22 08:34:39

已阅回复此楼关注TA 给TA发消息送TA红花 TA的回帖

orionwei

至尊木虫 (著名写手)

应助: 25 (小学生)
金币: 23566.7
帖子: 1990
在线: 243.8小时
虫号: 311310
注册: 2006-12-26
性别: GG
专业: 药物分析

【答案】应助回帖

Factor IX Complex
(fak' tor).
» Factor IX Complex conforms to the regulations of the federal Food and Drug Administration concerning biologics (see Biologics 1041 ). It is a sterile, freeze-dried powder consisting of partially purified Factor IX fraction, as well as concentrated Factors II, VII, and X fractions, of venous plasma obtained from healthy human donors. It contains no preservative. It meets the requirements of the test for potency in having not less than 80 percent and not more than 120 percent of the potency stated on the label in Factor IX Units by comparison with the U.S. Factor IX Standard or with a working reference that has been calibrated with it.
Packaging and storage— Preserve in hermetic containers in a refrigerator.
Expiration date— The expiration date is not later than 2 years from the date of manufacture.
Labeling— Label it with a warning that it is to be used within 4 hours after constitution, and to state that it is for intravenous administration and that a filter is to be used in the administration equipment.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Anita Y. Szajek, Ph.D.
Principal Scientific Liaison
(301) 816-8325 (BIO22010) Monographs - Biologics and Biotechnology 2

USP38–NF33 Page 3434