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Veeprho Group
เข้าร่วมเมื่อ 18 มิ.ย. 2013
VEEPRHO is a global manufacturer and supplier of Impurity Reference Standards for the Pharmaceutical industry. We are involved in the research, development, and supply of synthesized impurities, metabolites, intermediates, and API’s with custom synthesis.
Our global network is comprised with our headquarters in Czech Republic EU, manufacturing and R&D facilities in India, as well as distribution offices in New Jersey US and United Kingdom equipped to provide immediate support within all time zones.
We have strategically developed our business model to ensure product quality and regulatory compliance in a very cost-efficient way, ultimately allowing us to provide our products/services at competitive rates. Our team also works closely with clients to provide tailored solutions throughout entire project cycles so we deliver our services/products as per project needs.
Our global network is comprised with our headquarters in Czech Republic EU, manufacturing and R&D facilities in India, as well as distribution offices in New Jersey US and United Kingdom equipped to provide immediate support within all time zones.
We have strategically developed our business model to ensure product quality and regulatory compliance in a very cost-efficient way, ultimately allowing us to provide our products/services at competitive rates. Our team also works closely with clients to provide tailored solutions throughout entire project cycles so we deliver our services/products as per project needs.
N Nitroso Propranolol FormationToxicological Risks Regulationsand Analytical Detection
N-Nitroso propranolol is a nitrosamine impurity originating from the secondary amine group of propranolol hydrochloride, a non-selective beta-adrenergic receptor antagonist extensively employed in clinical therapeutics. The emergence of this impurity raises substantial concerns due to its potential genotoxic and carcinogenic properties. This comprehensive scientific review explores the chemical pathways leading to its formation, associated toxicological risks, pertinent regulatory guidelines-including acceptable intake limits-and advanced analytical methods for its detection. Emphasis is placed on elucidating the nitrosation mechanisms, factors influencing impurity formation, and strategic approaches for risk mitigation within pharmaceutical manufacturing processes.
มุมมอง: 9
วีดีโอ
Drug Degradation Mechanism | Veeprho
มุมมอง 12321 วันที่ผ่านมา
Drug Degradation Mechanism Impurities are critical quality attributes of drug substances and drug products because they have the potential to affect the safety and efficacy of the product. As per ICH Impurity is any component of the drug substance that is not the chemical entity that is defined as the drug substance; for a drug product, any component of a drug product that is not the drug subst...
Identification of Extractables and Leachables Impurities | Veeprho
มุมมอง 3528 วันที่ผ่านมา
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, ...
Analytical Method Development for New Products: Assay and Related Substances | Veeprho
มุมมอง 43หลายเดือนก่อน
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
มุมมอง 35หลายเดือนก่อน
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
มุมมอง 55หลายเดือนก่อน
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
มุมมอง 60หลายเดือนก่อน
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
มุมมอง 27หลายเดือนก่อน
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
มุมมอง 26หลายเดือนก่อน
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
มุมมอง 47หลายเดือนก่อน
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
มุมมอง 11หลายเดือนก่อน
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
มุมมอง 39หลายเดือนก่อน
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
มุมมอง 15หลายเดือนก่อน
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
มุมมอง 88หลายเดือนก่อน
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
มุมมอง 66หลายเดือนก่อน
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
มุมมอง 21หลายเดือนก่อน
Control of Pharmaceutical Impurities in Pharmaceutical Drug Products
Impurity Profiling in Drug Development
มุมมอง 110หลายเดือนก่อน
Impurity Profiling in Drug Development
Impurities in Pharmaceutical Drug Substances
มุมมอง 102หลายเดือนก่อน
Impurities in Pharmaceutical Drug Substances
Understanding the Classification of Potentially Mutagenic Impurities as per ICH M7 Guidelines
มุมมอง 99หลายเดือนก่อน
Understanding the Classification of Potentially Mutagenic Impurities as per ICH M7 Guidelines
N-Nitroso Ticagrelor (CAS 2476859-55-7) Formation & Cyclized Impurity Insights
มุมมอง 42หลายเดือนก่อน
N-Nitroso Ticagrelor (CAS 2476859-55-7) Formation & Cyclized Impurity Insights
Pharmaceutical Staff Qualifications and Training: The Path to Effective Practice & Compliance
มุมมอง 75หลายเดือนก่อน
Pharmaceutical Staff Qualifications and Training: The Path to Effective Practice & Compliance
Laboratory Quality Testing: Best Practices & Compliance
มุมมอง 11หลายเดือนก่อน
Laboratory Quality Testing: Best Practices & Compliance
Determination of Response factors of Impurities in Drugs by HPLC
มุมมอง 342 หลายเดือนก่อน
Determination of Response factors of Impurities in Drugs by HPLC
Nitrosamine Current Challenges and Way Forward
มุมมอง 502 หลายเดือนก่อน
Nitrosamine Current Challenges and Way Forward
Chemically Bonded Phases in Chromatographic Silicas
มุมมอง 342 หลายเดือนก่อน
Chemically Bonded Phases in Chromatographic Silicas
Good Documentation Practices in the Pharmaceutical Industry (GDocP)
มุมมอง 1052 หลายเดือนก่อน
Good Documentation Practices in the Pharmaceutical Industry (GDocP)
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