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Drug quality is defined not only how a drug is man
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Drug quality is defined not only how a drug is manufactured but also how it previously performed throughout its lifecycle in the pharmaceutical community. To uphold this, stability and impurity testing are essential.
The process of achieving this goal requires dependable manufacturing operations and reliable product performance throughout the entire production period until expiration. Pharmaceutical companies achieve global standards compliance through complete chemical, physical and microbiological assessments which detect potential impurities and determine shelf life.
The necessity for impurity profiling is crucial. The origins of pharmaceutical impurities come from various sources including raw materials and production intermediates as well as drug substance degradation that occurs with time. Small amounts of impurities can threaten both the drug’s operational effectiveness and patient health outcomes.
The International Council for Harmonisation (ICH) and United States Pharmacopeia (USP) along with other global regulatory bodies demand complete impurity profiling to detect and quantify and control these risks. The detection of chemical impurities through HPLC and LC-MS analysis requires advanced analytical techniques while microbial contaminant control demands reliable Culture Media and systematic monitoring protocols.
Brand like TM Media from Titan Biotech Ltd. is being a reliable partner in quality assurance. TM Media provides invaluable support in this area. They provide a full range of microbial test solutions aimed at satisfying the high qauality requirements of the pharmaceutical business. Their products allow the pharmaceutical companies to maintain and sustain a level of safety and trust.
For your convenience, Culture Media is available in two forms: Dehydrated Powder and Ready-to-use. Media bases and additives can be utilized for establishing specific test environments. They offer a variety of laboratory consumables and equipment for sanitary, smooth operations.
TM Media enables manufacturers to achieve cost-effective and efficient microbiological detection by providing pre-prepared tubes, bottles, and plates. Sterilization by gamma irradiation and triple packaging decreases the incidence of contamination. Gamma-irradiation sterilization, along with triple-layer packaging, gives assurance of sterility to the pharma manufacturers.
Microorganisms are prevalent, but in pharmaceutical manufacturing and cleanrooms, sterility requirements have limited the number of microorganisms.
Pharma stability and impurity testing is not just necessary for regulation compliance; it is critical for patient faith on which your company stands. By combining chemical analysis with checks for microbial safety, manufacturers can be sure their medicines stay pure, stable, and effective for the entire time they are meant to be used. TM Media Features an extensive range of Dehydrated Culture Media, Ready-to-Use Culture Media, Media Bases, Media Supplements, Lab Consumables and Equipment, it offers pharmaceutical companies necessary tools to support dependable stability and impurity testing. For each canister you give a patient, it has to be good for what the industry values most: quality without compromise.
