Veeprho Group
Veeprho Group
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Identification of Extractables and Leachables Impurities | Veeprho
Identification of Extractables and Leachables Impurities
Extractables are chemical compounds that migrate from any product contact material when exposed to an appropriate solvent under exaggerated conditions of time and temperature.
Leachables are chemical compounds that migrate into the drug formulation from any product contact material, including glass, plastic, stainless steel, elastomeric, or coating components as a result of direct contact with the drug formulation under normal process conditions or accelerated storage conditions and are found in the final drug product. They can increase the toxicity and impurity levels of the drug product and react with product components.
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Видео

Analytical Method Development for New Products: Assay and Related Substances | Veeprho
Просмотров 1016 часов назад
Analytical Method Development for New Products: Assay and Related Substances The purpose of the study is to develop an analytical method for the determination of Assay & Related substances in a new formulation product by HPLC using a UV-Visible detector. Visit our Websites:- www.veeprho.com | www.eshop-veeprho.com
Genotoxic Impurities: An Overview | Veeprho
Просмотров 13День назад
Genotoxic Impurities: An Overview Genotoxic Impurities (GTIs) in pharmaceutical products at trace levels are of concern due to human carcinogen and their detection at trace levels are of increasing concern to pharmaceutical industries and regulatory agencies. Pharmaceutical regulatory agencies Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have raised concerns about ...
Elemental Impurities: Risk Assessment and Significances | Veeprho
Просмотров 35День назад
Elemental Impurities: Risk Assessment and Significances The ICH Q3D Guideline for Elemental Impurities came into effect in January 2018 for all products for human use. It is supplementary safety-based guidance for toxic impurities that added the existing ICH Q3C and ICH M7 as well as the existing guidelines for non-toxic impurities ICH Q3A and non-toxic degradants ICH Q3B. However, it does not ...
Nitrosamine Impurities Traces in Ranitidine | Veeprho
Просмотров 13День назад
Nitrosamine Impurities Traces in Ranitidine Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease. The FDA and EMA investigation also led to the detection of N-nitrosodi...
Nitrosamine Impurity: A Regulatory Perspective | Veeprho
Просмотров 14День назад
Nitrosamine Impurity: A Regulatory Perspective The Regulatory agency announced that Nitrosamine impurities N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) are said to be present in generic drug substances and drug products, especially in angiotensin II receptor blockers (ARBs) and belong to a family of analog compounds referred to as the sartans. Further FDA and EMA investigation...
Thermogravimetric Analysis in Pharmaceuticals | Veeprho
Просмотров 21День назад
Thermogravimetric Analysis in Pharmaceuticals The terms Thermogravimetric Analysis (TGA) describes an experimental method whereby changes in mass are used to detect and measure the chemical and, less frequently, the physical (e.g., sublimation) processes that occur on heating a reactant under investigation. Data obtained by this method are often more accurate than those from other techniques. V...
Forced Degradation Studies for Drug Substances & Drug Products- Scientific Considerations | Veeprho
Просмотров 2614 дней назад
Forced Degradation Studies for Drug Substances & Drug Products- Scientific Considerations Forced degradation or stress testing is commenced to determine specificity when developing stability-indicating methods, particularly when little information is available about potential degradation products. These studies also provide information about the degradation pathways and degradation products tha...
Potential Impurities in Drug Substance & Drug Products | Veeprho
Просмотров 814 дней назад
Potential Impurities in Drug Substance & Drug Products Potential impurities are substances that are formed during the reaction or already present in the form of starting materials, by-products, or intermediate products. Potential Impurities have no therapeutic value and are potentially harmful. Therefore, they need to be controlled. Visit our Websites:- www.veeprho.com | www.eshop-veeprho.com
Forced Degradation Studies for Drug Substances and Drug Products - A Regulatory Considerations
Просмотров 1514 дней назад
Forced Degradation Studies for Drug Substances and Drug Products - A Regulatory Considerations Various regulatory guidance is available which provides useful definitions and general comments about degradation studies. However, guidance concerning the scope, timing, degradation condition, and best practices for degradation studies is very general. Various issues related to stress testing are add...
Nitrosamine Impurities and the Sartans | Veeprho
Просмотров 1214 дней назад
Nitrosamine Impurities and the Sartans Medicine Regulatory Authorities first became aware of the presence of the nitrosamine impurity, N-nitrosodimethylamine (NDMA), in products containing valsartan in July 2018. Valsartan is an Angiotensin II Receptor Blocker (ARB) and belongs to a family of analog compounds commonly referred to as the sartans. Visit our Websites:- www.veeprho.com | www.eshop-...
A Glimpse on Quality by Design (QbD) Approach in Pharmaceutical Industry | Veeprho
Просмотров 4714 дней назад
A Glimpse on Quality by Design (QbD) Approach in Pharmaceutical Industry The concept of Quality by design (QbD) means signifies designing and developing pharmaceutical products and manufacturing processes to ensure predefined product quality objectives. Quality by Design (QbD) brings a systematic approach to drug development that aims to ensure quality by applying analytical and risk-management...
Recent Control and Testing Strategies for Genotoxic Impurities
Просмотров 4814 дней назад
Recent Control and Testing Strategies for Genotoxic Impurities Analytical Method development and routine QC analysis for the determination of Genotoxic impurities (GI) at trace levels present exceptional challenges to pharmaceutical development and QC laboratories. These impurities are required to be controlled at trace levels in new drug substances and drug products. The International Conferen...
Control of Pharmaceutical Impurities in Pharmaceutical Drug Products
Просмотров 1721 день назад
Control of Pharmaceutical Impurities in Pharmaceutical Drug Products Impurities in pharmaceutical products do not offer any therapeutic benefit for the patient and sometimes they are potentially toxic. The impurity level is a critical quality attribute for a drug substance or a drug product. Impurity control is one of the most important tasks in a process scale-up. Visit our Websites:- www.veep...
Impurity Profiling in Drug Development
Просмотров 10121 день назад
Impurity Profiling in Drug Development Impurities in pharmaceuticals are unwanted chemicals that remain with the active pharmaceutical ingredients (APIs) or develop during formulation or upon ageing of both API and formulation. In the pharmaceutical industry, an impurity is considered as any other inorganic or organic material, or residual solvents other than the drug substances, or ingredients...
Impurities in Pharmaceutical Drug Substances
Просмотров 8421 день назад
Impurities in Pharmaceutical Drug Substances
Clindamycin: Drug Information
Просмотров 7921 день назад
Clindamycin: Drug Information
Understanding the Classification of Potentially Mutagenic Impurities as per ICH M7 Guidelines
Просмотров 7228 дней назад
Understanding the Classification of Potentially Mutagenic Impurities as per ICH M7 Guidelines
N-Nitroso Ticagrelor (CAS 2476859-55-7) Formation & Cyclized Impurity Insights
Просмотров 3528 дней назад
N-Nitroso Ticagrelor (CAS 2476859-55-7) Formation & Cyclized Impurity Insights
Pharmaceutical Staff Qualifications and Training: The Path to Effective Practice & Compliance
Просмотров 75Месяц назад
Pharmaceutical Staff Qualifications and Training: The Path to Effective Practice & Compliance
Laboratory Quality Testing: Best Practices & Compliance
Просмотров 11Месяц назад
Laboratory Quality Testing: Best Practices & Compliance
Duloxetine Drug Information
Просмотров 35Месяц назад
Duloxetine Drug Information
Analytical Method Transfer
Просмотров 27Месяц назад
Analytical Method Transfer
Determination of Response factors of Impurities in Drugs by HPLC
Просмотров 32Месяц назад
Determination of Response factors of Impurities in Drugs by HPLC
Nitrosamine Current Challenges and Way Forward
Просмотров 46Месяц назад
Nitrosamine Current Challenges and Way Forward
Chemically Bonded Phases in Chromatographic Silicas
Просмотров 30Месяц назад
Chemically Bonded Phases in Chromatographic Silicas
Counter Current Chromatography
Просмотров 82Месяц назад
Counter Current Chromatography
Good Documentation Practices in the Pharmaceutical Industry (GDocP)
Просмотров 103Месяц назад
Good Documentation Practices in the Pharmaceutical Industry (GDocP)
Liquid-liquid extraction (LLE), supported liquid extraction (SLE), and solid-phase extraction (SPE)
Просмотров 46Месяц назад
Liquid-liquid extraction (LLE), supported liquid extraction (SLE), and solid-phase extraction (SPE)
Regulatory Updates from FDA and EDQM
Просмотров 29Месяц назад
Regulatory Updates from FDA and EDQM

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