c*******7
发帖数: 525 | 1 The ability to rapidly measure metals at the low ppm levels is becoming
increasingly important in pharmaceutical manufacturing. Ensuring the removal
of metal impurities arising from residual organometallic catalysts is
required to avoid toxicity associated with heavy metals. Current approaches
(e. g. ICP MS) rely on the use of expensive equipment that cannot be
conveniently co-located with the reaction and purification equipment where
metal removal is performed, thus resulting in the need to transport
laboratory samples for testing and adding time and cost to the drug
development process. An improved approach would allow low ppm metals
analysis to be performed at point of use, employing affordable, robust
equipment that would be easy to operate by any lab technician (not requiring
specialized training). Ideally, such an instrument could be used for the
continuous monitoring of metal impurities associated with continuous
processing operations. Finally, a technique that would be amenable to detect
low ppm levels of the entire suite of metals commonly used in modern
synthetic organic chemistry (Pd, Rh, Cu, Zn, Fe, Ir, etc.), or at least a
few metals, would be preferable to a technique that is specific to a single
metal.
麻烦问一下大牛，通常这种金属检测试检测金属离子还是complex？一般都是有机溶剂
吗？有哪种有机溶剂是经常被用到的吗？万分感谢 | s**********8
发帖数: 25265 | 2 读 USP 232 and 233. 最普通的sample prep是close vessel strong acid digestion
removal
approaches
【在 c*******7 的大作中提到】
: The ability to rapidly measure metals at the low ppm levels is becoming
: increasingly important in pharmaceutical manufacturing. Ensuring the removal
: of metal impurities arising from residual organometallic catalysts is
: required to avoid toxicity associated with heavy metals. Current approaches
: (e. g. ICP MS) rely on the use of expensive equipment that cannot be
: conveniently co-located with the reaction and purification equipment where
: metal removal is performed, thus resulting in the need to transport
: laboratory samples for testing and adding time and cost to the drug
: development process. An improved approach would allow low ppm metals
: analysis to be performed at point of use, employing affordable, robust
| c*******7
发帖数: 525 | 3 谢谢楼上的回复，但是usp232是指最后的药品的impurity检测吧，但是在制药过程中是
不是也需要监测metal impurity的含量啊？ | s**********8
发帖数: 25265 | 4 Raw material also needs to meet heavy metal spec | a****e
发帖数: 606 | 5 API, excipients, and drug product. I don't think there is regulatory
requirement for intermediates.
The new USP chapter will be effective on Dec 2015. A totally re
-write of the current heavy metal chapter. The effective date is pushed back
from June 2014 because of the resistance from the industry.
Is this change partially triggered by the scandal of gelatin made from waste
leather in china?
【在 s**********8 的大作中提到】
: Raw material also needs to meet heavy metal spec
| o**n
发帖数: 2130 | 6 ICP只能检测金属离子,一般只能测试水溶液中的样品 | s**********8
发帖数: 25265 | 7 heavy metal is an important quality aspect, however, there is no harmonized
procedure across industry. before it was tested by USP 231, which is just a
color limit test for combined cd pb as hg. with availability of ICP MS ICP
OES, it is highly recommended now to refine this procedure.
however, due to so many existing products on market, this is not gonna
happen overnight. regulatory bodies are making manufactures aware of this
change for a really long grace period before implementation just in case
there is no enough response time.
also, ICH is rolling out heavy metal quality guide under Q3 impurity group
to harmonize this testing requirement and practice. I believe once this ICH
guideline is released, the procedure and requirement will be clear.
ICH Q3d draft on heavy metal:
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guide
A presentation: Heavy Metals – USP Perspective
http://www.fda.gov/ohrms/dockets/ac/08/slides/2008-4370s1-10-Gu
back
waste
【在 a****e 的大作中提到】
: API, excipients, and drug product. I don't think there is regulatory
: requirement for intermediates.
: The new USP chapter will be effective on Dec 2015. A totally re
: -write of the current heavy metal chapter. The effective date is pushed back
: from June 2014 because of the resistance from the industry.
: Is this change partially triggered by the scandal of gelatin made from waste
: leather in china?
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