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31-45 of 61 results
Amino Acid Analysis in Pharmaceuticals
| By Butterworth Laboratories Ltd
The European Pharmacopeia (Ph Eur) is moving away from the historical Thin Layer Chromatography technique (TLC) 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 history of the test, the benefits of the change and considerations for validation of the LC approach to analysis.
Contract Research & Services > Contract Services > White Papers
Enhanced Residual Solvents Analysis: A Practical Approach to Sampling, Transport, Storage and Analysis.
| By Butterworth Laboratories Ltd
Residual solvents are organic volatile chemicals used or produced in the manufacture of active pharmaceutical ingredients (API), excipients or drug products, which remain in the material at the end of the manufacturing process. Their control is important in limiting exposure and guidelines exist to maintain patient safety, not just to satisfy competent authorities. It is a requirement that all pharmaceutical substances comply with ICH limits even if not required by individual monographs or if no compendial monograph exists.
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Elemental Impurity Analysis in Pharmaceuticals
| By Butterworth Laboratories Ltd
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. This paper will give an overview of the current method limitations, considerations for the new methodology and the risk-based assessments being carried out by manufacturers.
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Designing Wellness for Fun and Satisfaction: Gummies - Based Nutrition
| By Softigel pbr
The gummy delivery form for vitamins, minerals and supplements is the single-largest source of growth among the supplements category. Vitamin users report preference for gummy/soft chewable products because these offer not only pleasure and a fun experience, but efficacy and convenience. The selection of materials during the design process of the formula is critical for the final product in order to meet the expectations of the consumers, which is to find a healthy product that will give them a delicious reward as well. Based on the design and development process, this paper reviews review in detail the stage of selection of materials and validation as a critical phase to obtain a product that represents quality and stability as well as the specific requirements of the costumers and the consumers.
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pAVEway™ Expression System for the Efficient Expression of Therapeutic Proteins
| By Fujifilm Diosynth Biotechnologies
One of the major bottlenecks in the production of biopharmaceuticals is the efficient expression of therapeutic proteins in microbial or mammalian cells. The Escherichia coli pAVEway™ expression system described here has been developed to ensure high product titres and efficient scale up to GMP manufacture, whilst minimising many common issues seen in other expression systems, such as ‘leaky’ expression (expression of recombinant protein in the absence of inducer).
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Signed by Syncom - Designing Chemistry in 25 Milestones
| By Syncom BV pbr
There are so many reasons to be proud of this company. In the first 25 years of Syncoms’ existence, we have truly made a contribution to science, the pharmaceutical industry, the health of many people across all continents, to the economy of our city (Groningen), as well as to the careers and lives of employees and former employees.
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Syncom Catalogue
| By Syncom BV pbr
Click here to download our catalogue of products.
Contract Research & Services > Contract Services > White Papers
Softigel Technologies Brochure
| By Softigel pbr
From selecting the best gelatin source, throughout the soft gelatin capsule development, manufacturing, labeling and packaging process, until delivering a final product to your warehouse with supporting marketing strategies, SoftiGel is vertically integrated to fulfill your needs and deliver the best drug to any marketplace in the world.
Contract Research & Services > Contract Services > White Papers
SoftiGel Product Catalogue
| By Softigel pbr
Download our whitepaper for details of our pharmaceutical capsules and products.
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Lindeq Brochure
| By Lindeq
Discover the Lindeq brochure which provides an overview of the company and the people behind, our solutions, services and systems.
Contract Research & Services > Contract Services > White Papers
Lindeq’s electronic PSMF solution
| By Lindeq
Find out more about our time saving, fully compliant PSMF solution, meeting all by the EMA and HMA required (quality) standards.
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Lindeq’s intelligent Quality Management System ItQMS
| By Lindeq
Have a look at our web-based ItQMS which includes document and training workflow, non-conformity reporting and easy controlled online access.
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Lindeq's Drug Safety Database incl. maintenance solution
| By Lindeq
Discover our solution we provide together with our safety database partner BaseCon.
Contract Research & Services > Contract Services > White Papers
31-45 of 61 results