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October 07, 2016
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   White Paper on Elemental Impurities: Implications for Manufacturers of Drug Products, APIs, and Excipients
MilliporeSigma
The ICH Q3D Guideline for Elemental Impurities introduces risk assessment approaches and limits for maximum permitted daily exposure based on safety assessments for chronic exposure. However, it does not provide specific daily limits for major components of final drug products, bringing excipients in particular under scrutiny. Unlike APIs, excipients do not have established daily doses, leaving manufacturers with less information for calculating concentration limits. This white paper discusses an ICH Q3D-compliant control strategy model for risk assessment.

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» Industry News
 
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» Featured Articles
Scaling-Down Local Mixing Effects for Biotechnology Applications
Scaling-Down Local Mixing Effects for Biotechnology Applications
The scale-up/down of an industrial process is still a big challenge. The mixing conditions should ... read more »
Resolution of Low Endotoxin/ Lipopolysaccharide Recovery (LER/LLR)Testing
Resolution of Low Endotoxin/ Lipopolysaccharide Recovery (LER/LLR)Testing
The Low Endotoxin (LER) and Lipopolysaccharide Recovery (LLR) phenomena have been debated as a ... read more »
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» Featured Videos
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  Automate your endotoxin testing with robotic pipetting
Automate your endotoxin testing with robotic pipetting
Automate your Pyros Kinetix®Flex Assay from Associates of Cape Cod with the Hudson SOLO™ Robotic Pipettor. The SOLO Pipettor accommodates all required... read more »
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  NanoRam for Non-Destructive ID and Verification of Materials
NanoRam for Non-Destructive ID and Verification of Materials
This video demonstrates how the NanoRam handheld Raman spectrometer makes non-destructive raw material identification faster and easier. It can ... read more »

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» Featured Whitepapers & Application Notes
Stray Light and Performance Verification Advances in UV/VIS Spectroscopy
Stray Light and Performance Verification Advances in UV/VIS Spectroscopy
This paper discusses the origin and accurate measurement of stray light. Methods for measuring stray light according to the current and previous version of the US Pharmacopeia are compared and the ... read more »
Innovative Membrane Filtration Technologies for Upstream and Downstream Bioprocessing
Innovative Membrane Filtration Technologies for Upstream and Downstream Bioprocessing
In bioprocessing, process development scientists and engineers regularly seek improvements in filter performance to facilitate safe, cost-effective manufacture of drug and vaccine products. The latest... read more »

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| Events
EVENT
  Pharmaceutical Microbiology
London, UK –  01/18/2017
SMi proudly presents the return of the 6th annual Pharmaceutical Microbiology conference to London in 2017! ?The microbiology market has ... event details »
EVENT
  PHARM Connect Congress 2017
Budapest, Hungary –  02/22/2017
PHARM Connect Congress is the largest and most important pharmaceutical and biotechnology business summit in the Central Eastern European and the CIS ... event details »

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