Two new quality standards, one for MDMA and another for psilocybine, have been published. These standards each specify the minimum quality requirements for both the active pharmaceutical ingredient (API) and finished product. From 6 January 2025, all MDMA and psilocybine API and finished products supplied or manufactured in Australia must comply with the relevant TGO. Read more: https://lnkd.in/gNDrfTyi
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When others concentrate on the cost we focus on quality. Our Active pharmaceutical ingredients is independently tested to the highest quality standards. Sulfachloropyrazine Sodium Monohydrate CAS 1392129-96-2: https://lnkd.in/gjjJ9Khz #activepharmaceuticalingredients #sulfachloropyridazinesodium
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How To Purchasing Highly Potent Active Pharmaceutical Ingredients (HPAPIs)?
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Nitrosamine impurities are nitroso derivatives where the nitroso group is attached to an amine. The active pharmaceutical ingredient (API) derived class of nitrosamines are known as nitrosamine drug-substance-related impurities (NDSRI). They are structurally related to APIs as there could be degradant products or byproducts generated during the storage period or during the manufacturing process of the drug product. The acceptable intake for N-nitroso sitagliptin impurity (3-nitroso-1-(3- (trifluoromethyl)-5,6-dihydro- [1,2,4] triazolo[4,3-a] pyrazin-7(8H)-yl)-4-(2,4,5- trifluorophenyl) butane-1-one) is 37 ng/day as per the European Medicines Agency (EMA) regulation. This application note describes the procedure for the multiple reaction monitoring (MRM)-based low-level quantitation of nitroso sitagliptin using an Agilent 1290 Infinity II liquid chromatograph (LC) coupled to an Agilent 6475 triple quadrupole mass spectrometer (LC/TQ). Read more: https://lnkd.in/dwiqWTVT
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Sniffles dramatically "Spring is beautiful they said...” 🤧🐝🌸🌳 Are you one of many that suffer from pesky hay fever? Constantly stocked up on antihistamines? Well, us too. In June's Map of the Month, we use Raman to examine a widely used antihistamine formulation that contains the active pharmaceutical ingredient (API) cetirizine hydrochloride (CTZ). Find out how the RM5 can detect the API and other important compounds, and visualise their distribution within a drug formulation in our latest Map of the Month. https://ow.ly/OwAN50S8628 #MyEdinburghInstrument #pharmaceutical
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WHO: Draft for the Prevention and Control of Nitrosamine Contamination The WHO has published a new draft guideline on considerations for the prevention and control of nitrosamine contamination in pharmaceutical products. This guideline applies to all manufacturers of excipients, active pharmaceutical ingredients and finished pharmaceutical products. >>> read more: https://bit.ly/4dnhIra #gmpnews #gmp #WHO #nitrosamine #draft
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Edinburgh Instruments Sniffles dramatically "Spring is beautiful they said...” 🤧🐝🌸🌳 Are you one of many that suffer from pesky hay fever? Constantly stocked up on antihistamines? Well, us too. In June's Map of the Month, we use Raman to examine a widely used antihistamine formulation that contains the active pharmaceutical ingredient (API) cetirizine hydrochloride (CTZ). Find out how the RM5 can detect the API and other important compounds, and visualise their distribution within a drug formulation in our latest Map of the Month. https://ow.ly/OwAN50S8628 #MyEdinburghInstrument #pharmaceutical
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Orally disintegrating films (ODFs) are an appealing drug dosage form because they allow safe, easy, and exact dose administration of an active pharmaceutical ingredient (API). The API and excipients are mixed on a molecular level with HME, resulting in a more uniform dispersion of the API in the ODF, which increases the bioavailability of the drug. Learn more about the benefits of ODFs. https://lnkd.in/gHSkM8aQ #HME #ODF #DrugDelivery
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When we think about medications, we often focus on the active pharmaceutical ingredients (APIs) – the compounds that directly treat our ailments. However, lurking behind these therapeutic superstars is a supporting cast of ingredients known as excipients. These seemingly inert substances play a crucial role in determining how effectively a drug works in the body, a property known as bioavailability. https://lnkd.in/eMyGAPc3
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🔹 Bioequivalence EU: two medicinal products with the same active ingredient are bioequivalent if they have similar pharmaceutical properties and their bioavailability in terms of rate and extent after the same molar dose falls within acceptable predefined ranges, ensuring comparable safety and efficacy. 🔹 Bioequivalence US: “Bioequivalence is the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.” #Bioequivalence #EU #US #medicinal #onlinecourses #SymmetricTraining
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𝘐𝘯𝘨𝘳𝘦𝘥𝘪𝘦𝘯𝘵 𝘚𝘱𝘰𝘵𝘭𝘪𝘨𝘩𝘵: Actylis manufactures 𝟮-𝗣𝗵𝗲𝗻𝗼𝘅𝘆𝗲𝘁𝗵𝗮𝗻𝗼𝗹 multi-compendial meeting USF-NF, EP and BP monographs. 2-Phenoxyethanol can be used as a vaccine preservative, as well as an antibacterial active pharmaceutical ingredient (API) for pharmaceutical preparations. Its low toxicity and its excellent bactericidal and bacteriostatic properties make 2-Phenoxyethanol highly valued in pharmaceutical applications. Actylis' 2-Phenoxyethanol Multi-Compendial Grade: • Is an excipient grade GMP-manufactured ingredient complying to IPEC GMP standard • Meets USP-NF and EP compendia for Phenoxyethanol • Truly GMP and GDP compliant start to finish, full supply chain transparency To know more, discover the product information in the sheet below or request a quote here https://lnkd.in/eRirfQWr #Actylis #ThePartnerOfChoice #Pharma #Biopharma
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