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ICH Q3D Guideline for Elemental Impurities – How BASF supports its pharmaceutical customers towards compliance - BASF SE

19-Mar-2015 - On December 19, 2014, the Guideline "ICH Q3D - Elemental Impurities" was issued by the ICH, providing a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients. The required comprehensive view on a products’ elemental...
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The in-PharmaTechnologist Anti-counterfeiting Forum - William Reed Business Media

18-Mar-2015 - Drug counterfeiting: a pharmaceutical industry problemCounterfeiters rely on two things: poorly secured pharmaceutical supply chains; and the fact people want to pay less for less for drugs.Most fake erectile dysfunction drugs seized in Europe contain at least some trace of...
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Amino Acid Analysis According to Ph.Eur 2.2.56 - SGS

23-Feb-2015 - Employing spectrophotometry and liquid chromatography quantitation of Ninhydrin-positive substances achieves 0.05% reporting sensitivity as required by the updated Ph.Eur 2.2.56. This white paper details our results compliant with the new monographs
Download now!Technical / white paper

A Method to Meet the New Ph Eur Ninhydrin-Positive Substances Requirement - Butterworth

03-Feb-2015 - The European Pharmacopeia (Ph Eur) is moving away from the historical thin layer chromatography technique for the determination of Ninhydrin-positive substances, to more specific and sensitive methods utilising Liquid Chromatography (LC) or Amino Acid Analysers. This paper will explore the...
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Residual moisture in lyophilized pharmaceuticals - Metrohm – customized analysis for the pharmaceutical industry

15-Sep-2014 - This method describes near-infrared spectroscopy in diffuse reflection for determining residual moisture in a lyophilized pharmaceutical product. The results were correlated with the water content determined by Karl Fischer.
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Customized Biosimilarity Analytical Testing from Catalent - Catalent

26-Jan-2015 - Assessment of biosimilar molecules requires an orthogonal analytical approach.  Any one particular analytical technique is not able to fully define the physical and biological characteristics of the original biotherapeutic or its potential biosimilar.  Instead, a panel of analytical techniques must...
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OptiPact™ Technology Introduced by Catalent - Catalent

19-Jan-2015 - Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, has announced the launch of OptiPact™, an integrated service and technology offer based on the company’s expertise in roller...
Download now!Technical / white paper

Using texture analysis in regenerative medicine - Stable Micro Systems

03-Nov-2014 - Research in the field of regenerative medicine is progressing at a rapid pace. Download this free white paper to find out how texture analysis can help set quality control standards for the next generation of health care.
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Nondestructive, single tablet analysis - Metrohm – customized analysis for the pharmaceutical industry

16-Jun-2014 - NIRS Spectroscopy allows rapid (<30 s) and nondestructive screening of solid dosage forms. It requires neither sample preparation nor solvent use. Interferences that derive from scattering are minimized by converting to second-derivative spectra.
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Determination of moisture in a protein sample using a portable NIR instrument - Thermo Fisher Scientific

03-Jun-2014 - Near infrared spectroscopy has been used effectively to measure moisture in a wide variety of samples. Due to the large overtone band for water in NIR, levels of accuracy tend to be high and limits of detection are lower than...
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Elemental Impurity Analysis in Pharmaceuticals - Butterworth

06-May-2014 - A method to identify the presence of heavy metals in pharmaceuticals was introduced in the United States Pharmacopoeia more than 100 years ago. Today pharmaceutical companies are still using essentially the same method, the USP <231> Heavy Metals Limit Test....
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Near-infrared spectroscopy - Metrohm – customized analysis for the pharmaceutical industry

01-May-2014 - NIRSystems Technology:  Improved productivity and faster quality control of starting materials, intermediates and final products. Learn more
Download now!Technical / white paper

Validation, Qualification and Calibration - SGS

21-Apr-2014 - This white paper outlines outsourcing requirements for Validation, Qualification and Calibration activities in a pharmaceutical facility. These ongoing activities cover development, operation, and maintenance and must meet high quality standards.
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Want to Strengthen Your Supply Chain Security? -

18-Mar-2014 - The challenges of ensuring safe drugs for patients are universal, international and pervasive. The Global Forum on Access to Safe Medicines brings together a host of global leaders dedicated to improving supply chain security and preventing falsified, counterfeit, diverted and...
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Enhancing Actives Delivery for Optimal Formulation Efficacy - Croda

24-Feb-2014 - Excipients designed to enhance skin penetration can maximize the efficacy of topical formulations.  Through lipid disruption and skin polarity modification, topical penetration enhancers allow for more targeted API delivery.  Fill out the form for more information
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New Developments in Controlled Nucleation during Lyophilization - IMA LIFE

08-Jan-2014 - For the past few years, controlled nucleation during the freeze drying process has been a subject of great interest to the bio-pharm community. The potential benefits of enhanced process control, process repeatability, and cycle time reduction are exciting to both...
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Texture analysis for pharma QC - Stable Micro Systems

25-Nov-2013 - Looking for objective, reliable and cost-effective QC solutions? Download this free white paper to find out how texture analysis can help uphold quality standards while providing essential product data and benchmarking statistics.
Download now!Case study

Clinical Document distribution - Secure and Automated - PharmaSOL

04-Nov-2013 - psiXchange automates the distribution of your safety related documents. The distribution engine handles country specific rules and user specific escalation paths, with full receipt tracking. Recipients don't have to learn a new system, and your internal overhead is dramatically reduced.psiXchange...
Download now!Technical / white paper

NEOBEE® MCTs Enhance Pharmaceutical Bioavailability - Stepan Lipid Nutrition

04-Nov-2013 - An efficient solvent for many lipophylic drugs and vitamins, NEOBEE® MCTs emulsify in aqueous environments and help uptake in intestinal cells. They are odorless, tasteless and extremely stable and offer a safe, versatile, affordable and simple solution for many bioavailability...
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METHOD VALIDATION – USP PROPOSED <233> - SGS

04-Nov-2013 - The USP is continuing to modify a proposal for using inductively coupled plasma (ICP) and ICP-mass spectroscopy (ICP-MS) to detect contaminating heavy metals in drug products. The new USP <233> describes testing methods to detect elements of interest specifically, accurately...

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