加拿大外贸
Dear Linda,Working Standard
We already supplied product of ****** Pharma grade to many customers for cough drugs.
The local FDA requires the Registration number to be renewed every 5 years & during the renewal the FDA will request complete document related to the formulation and API.
All the API to be completed with the CoA (Certificate of Analysis) of the Working Standard, including the Ammonium Chloride.
The Working Standard has to mentioned to which Reference Standard, it is re-produced.
Kindly support for the required registration document above, otherwise the customer will not be able to extend their Marketing Authorization.
Herewith, we attach information of Working Standard.
http://wiki.answers.com/Q/Differ ... d_in_analytical_lab
A reference standard is the traceable, raw material standard (usually in crystallized form) that you dissolve and volumetrically dilute to make your working standard. The working standard is what you use to "do your work."
Let's say you are performing an HPLC purity and degradation assay on aspirin tablets for your client. The client corporation would supply the reference standard(s) (or in this case could be purchased from the US Pharmacopeia) with a lot number, purity coefficient and expiration date (among other things like storage requirements). This information makes it traceable and is recorded in the preparation notebook. Then per the assay method the working standard is dissolved in a volumetric flask and diluted to volume (with subsequent dilutions if necessary) to make the working standard. The working standard is then used to make calibration curve injections on the HPLC to estimate the quantities of your aspirin tablets being analyzed.
Note: In the above example, reference standards are also used to make a system suitability solution. This would contain the A) reference standard material used for the calibration curve and B) another reference standard of at least one possible degradant to show peak separation.
这是客户的邮件去年走的货，现在非问我要 Working Standard，这个是什么东西啊？
有知道的朋友请留意下，谢谢了！
评论
貌似就是类似于你们产品的适用方法，用法用量标准什么的吧
评论
工作标准，药典的标准品~
评论
分析中的working standard常译为 标准品，
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