蒲公英 - 制药技术的传播者 GMP理论的实践者

搜索
查看: 2154|回复: 4
收起左侧

[其他] 【求助】USP附录<1115><1112><922>中英文版,谢谢!

[复制链接]
回帖奖励 80 金币 回复本帖可获得 10 金币奖励! 每人限 1 次
大师
发表于 2021-4-2 08:12:18 | 显示全部楼层 |阅读模式

欢迎您注册蒲公英

您需要 登录 才可以下载或查看,没有帐号?立即注册

x
江湖救急:论坛谁有USP附录<1115><1112><922>中英文版,麻烦分享一下,如果只有英文版也可以,谢谢!

回复

使用道具 举报

药徒
发表于 2021-4-2 08:43:40 | 显示全部楼层

回帖奖励 +10 金币

922没有找到。

1112.pdf

1.33 MB, 下载次数: 96, 下载积分: 金币 -1

1112

1115.pdf

3.89 MB, 下载次数: 75, 下载积分: 金币 -1

1115

点评

收到,谢谢!  发表于 2021-4-2 09:33
回复

使用道具 举报

药徒
发表于 2021-4-2 08:48:01 | 显示全部楼层
<922> Water Activity
Type of Posting: General Announcement
Posting Date: 30–Mar–2018
Input Deadline:  30–Apr–2018
Expert Committee: General Chapters—Physical Analysis

Proposed new title:  <922> Water Activity

Suggested audience: Suppliers and manufactures of excipients, drug substances, drug products, veterinary products, regulatory agencies, and manufacturers of water activity instruments

Estimated proposal PF: Pharmacopeial Forum 44(6) [Nov.–Dec. 2018]

Background and objective(s):  
Water activity (Aw) refers to the effective concentration of pure water in a raw material or product. When water is strongly bound to a solute or surface, it does not contribute to the water activity. Measurements of water activity are made by allowing a sample to equilibrate with the moisture in the headspace above the sample and then measuring the equilibrium relative humidity (ERH) of the headspace. At equilibrium, the ERH is also a measure of the Aw in the formulation. Water activity meters measure the relative humidity with a moisture-dependent resistor or capacitor or may use psychometry (wet bulb temperature) or dew point depression. Regardless of the principle of measurement, water activity meters can be calibrated and qualified using the same saturated salt reference solutions. This chapter will outline the recommended methods to qualify, calibrate, and use water activity meters to accurately measure the water activity of raw materials and products.

Description of scope and application:  This new general chapter is intended to provide guidance for performing measurements of water activity (Aw). The general chapter will specify methods for qualification of instruments, calibration of instruments, methods for performing water activity measurements, and reporting of results.

Preliminary outline:  

    Introduction
    Background
    Application of Water Activity Measurements
    Types of Water Activity Meters
    Electronic Hygrometer
    Resistance hygrometer
    Capacitive hygrometer
    Psychrometric (wet bulb temperature)     
    Dew Point
    Chilled-mirror hygrometer
    Thermocouple
    Hair hygrometer
    Freezing-point depression sensor
    Near infrared spectrometry
    Operation and Calibration of Water Activity Meters
    Standard Saturated Salt Solutions
    Calibration of Water Activity Meters
    Dew Point Hygrometer
    Electronic Hygrometer
    Near Infrared spectrometry
    Precision/Repeatability Assessment (Performance Qualification)
    Measurement of Water Activity
    Sample Preparation
    Calibration Check
    Measurement Procedure
    Reporting Results
    Assay Verification and Validation
  Troubleshooting
    Dew Point Hygrometer
    Electronic Hygrometer
    Near Infrared spectrometry
    Glossary
    References
Anticipated proposed design phase activities: The general chapter will be developed by a Joint Subcommittee with representation from General Chapters—Physical Analysis, General Chapters—Microbiology, and the Non-botanical Dietary Supplements Expert Committees. In addition, the Joint Subcommittee will assess the impact of the new general chapter on the existing General Chapter <1112> Microbiological Attributes Of Nonsterile Pharmaceutical Products—Application Of Water Activity Determination and work with the General Chapters—Microbiology EC to update <1112> to align with this new general chapter.

Anticipated implementation timing: Routine

Contact: Antonio Hernandez-Cardoso, M.Sc., Senior Scientific Liaison, (301-816-8308),AHC@usp.org).
回复

使用道具 举报

药徒
发表于 2021-5-18 21:04:53 | 显示全部楼层

回帖奖励 +10 金币

本帖最后由 lin428 于 2021-5-18 21:06 编辑

这是之前下载的征求意见搞,你可以参考一下,现行版目前没有

USP 922 Draft revision.pdf

318.44 KB, 下载次数: 54, 下载积分: 金币 -1

回复

使用道具 举报

您需要登录后才可以回帖 登录 | 立即注册

本版积分规则

×发帖声明
1、本站为技术交流论坛,发帖的内容具有互动属性。您在本站发布的内容:
①在无人回复的情况下,可以通过自助删帖功能随时删除(自助删帖功能关闭期间,可以联系管理员微信:8542508 处理。)
②在有人回复和讨论的情况下,主题帖和回复内容已构成一个不可分割的整体,您将不能直接删除该帖。
2、禁止发布任何涉政、涉黄赌毒及其他违反国家相关法律、法规、及本站版规的内容,详情请参阅《蒲公英论坛总版规》。
3、您在本站发表、转载的任何作品仅代表您个人观点,不代表本站观点。不要盗用有版权要求的作品,转贴请注明来源,否则文责自负。
4、请认真阅读上述条款,您发帖即代表接受上述条款。

QQ|手机版|蒲公英|ouryao|蒲公英 ( (京)-非经营性-2014-0058 京ICP证150354号 京ICP备14042168号-1 )

GMT+8, 2024-3-29 23:35

Powered by Discuz! X3.4运维单位:苏州豚鼠科技有限公司

Copyright © 2001-2020, Tencent Cloud.

声明:蒲公英网站所涉及的原创文章、文字内容、视频图片及首发资料,版权归作者及蒲公英网站所有,转载要在显著位置标明来源“蒲公英”;禁止任何形式的商业用途。违反上述声明的,本站及作者将追究法律责任。
快速回复 返回顶部 返回列表