American Pharmaceutical News In Review

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April 05, 2017

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Analyzing Glass Container Quality

Glass has been the material of choice for packaging pharmaceuticals. However, the quality of glass for packaging pharmaceuticals can vary. It is important to test glass for elemental impurities and leachables and extractables. In this video, Jeffrey Reid, Global Marketing Manager, DWK, provides information on the inner surface chemistry of Wheaton glass and the tests and quality assurances that go into producing pharmaceutical-quality glass packaging.

	Industry News

PDA Recognized as an ANSI Accredited Standards Developer

FDA Accepts for Review the Application of IMBRUVICA® for Chronic Graft-Versus-Host-Disease (cGVHD)

FDA Oks Abridged Clinical Trial for Wockhardt’s Antibiotic

Astellas to Acquire Ogeda SA

FDA Grants Kitov a Waiver for New Drug Application Filing Fee

Mylan Provides Update on Expanded Voluntary Worldwide Recall of EpiPen® Auto-Injector

	Featured Articles

Particle Engineering For Improved Bioavailability In Oral Solid Dose Medications Particle Engineering For Improved Bioavailability In Oral Solid Dose Medications Oral solid dose (OSD) form medications remain the industry juggernaut. Though biopharmaceuticals ... read more »

Experience and Expertise Facilitate Controlled Substance Manufacturing Experience and Expertise Facilitate Controlled Substance Manufacturing Requirements for the manufacture of controlled substances impact all aspects of drug development, ... read more »

	Featured Video

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 »

GlycanAssure Glycan Analysis Technology from Thermo Fisher Scientific
GlycanAssure Glycan Analysis Technology from Thermo Fisher Scientific
The Applied Biosystems GlycanAssure Glycan Analysis and Quantitation System is the first glycan analysis platform that combines both throughput and ... read more »

	Featured Products

i-Raman Plus High Resolution Fiber Optic Raman System
read more »

	Featured Whitepaper

Physical, Chemical, and Performance Assessment of Amorphous Solid Dispersions of Ritonavir Prepared by Hot Melt Extrusion
Physical, Chemical, and Performance Assessment of Amorphous Solid Dispersions of Ritonavir Prepared by Hot Melt Extrusion
In this study amorphous solid dispersions of ritonavir (RTV) were prepared by hot melt extrusion using the polymeric carriers AFFINISOL™ HPMC HME and copovidone at 3 different drug loads (25%, 33% and... read more »

Elemental Impurities: Implications for Manufacturers of Drug Products, APIs, and Excipients
Elemental Impurities: Implications for Manufacturers of Drug Products, APIs, and Excipients
The International Conference on Harmonization (ICH) finalized the ICH Q3D Guideline for Elemental Impurities in December 2014. Regulators are now implementing the requirements worldwide. The U.S. ... read more »

	Events

CPhI China 2017
Shanghai, China – 06/20/2017
CPhI & P-MEC China are the leading pharma events in China and Pacific region. It acts as a platform for 33,000+ local and international pharma experts... event details »

Quality Risk Management Summit 2017
Lisbon, Portugal – 05/10/2017
Summit Overview: Presentations and panel discussions will take place throughout the 2-days, led by senior industry and regulatory experts for a robust... event details »

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