Leachables from Dry Powder Inhalers (DPI) - MORE>
Leachables may impact drug efficacy and potency - MORE>
Applications in pharmaceutical analysis.
The process of bringing a new pharmaceutical drug to market requires assuring its integrity during the entire life cycle – from concept, through manufacturing and eventually to the consumer.
Whether solids, liquids or gases, Raman analysis can be used to rapidly characterize the chemical composition and structure of a sample, supporting drug formulation, development, and scale-up. It can also be helpful in quality control to make sure that the product contains the right amount of active, its polymorph, excipient and other additives.
Pharmaceutical Testing – USP <660> containers-glass
Testing glass containers for their hydrolytic resistance to protect your medicinal products
Containers and container closures must not interact physically or chemically with the substance in any way that would alter its quality. They must retain a drug’s therapeutic efficacy from the time of packaging until it is consumed.
Specifically, glass containers that come into direct contact with pharmaceutical products must comply with USP <660> CONTAINERS – GLASS. This method guides the selection of appropriate containers for a given drug formulation, assuring drug integrity and commercialization of quality medicines. Failure to meet the compendial requirements will compromise the integrity of the drug product, resulting in a severe public health hazard.
This article will help you understand:
- the glass types
- the regulation and its updates
- the testing: Glass Grains test and Surface Glass test.
Validating ICP-MS for the Analysis of Elemental Impurities According to Draft USP General Chapters <232> & <233>
The presence of impurities in pharmaceutical samples is a concern, not only because of potential toxicity, but also because of the potential impact on drug stability, shelf-life, or unwanted side-effects.
Both organic and inorganic (elemental) impurities must be monitored and controlled in raw materials used for drug manufacturing, in intermediates and active pharmaceutical ingredients (APIs), in excipients (stabilizers, fillers, binders, colorings, flavors, coatings, and so forth), and in final drug products.
Bridge Bearing Testing
An overview of the Ontario Provincial Standard Specification – OPSS 1202
Design and construct bridges that perform greatly under every environmental condition is a major tenet of civil engineers and construction companies. The bridge structure should be able to cope with unavoidable degradation factors such as cold, heat and ozone exposure, which cause vibrations and movements in the bridge.
Bridge bearings are key structural elements able to accommodate these movements and reduce the stresses involved. Their efficiency highly influences the stiffness and stability of a bridge. Hence, a bridge will not be effective if the supporting bearings are faulty. Adherence to the Ontario Provincial Standard Specification - OPSS 1202 - means that the structural integrity of the bridge is ensured under all circumstances.
Detecting contamination and identifying sources
The presence of unexpected and unwanted particulate material in pharmaceuticals may affect the product performance and pose a health hazard to patients. The Food and Drug Administration (FDA) and Health Canada demand that any contaminants be identified and analyzed to guarantee the integrity of the product. Also, manufacturers need to know the source of contamination to take necessary measures to mitigate production delays and maintain good customer relationships.
Particulate identification and analysis allow detecting the contaminant and source so that manufacturing processes can be improved, recurrent contamination problems avoided, and the production of safe products is safeguarded.
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