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- Czech Republic, EU
- Mumbai, India
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Documentation
内容: HPLC、MASS/LC-MS、1H NMR、FT-IR、含量、構造解析レポート（SER）、および製品に応じた追加分析データ。
オンライン注文
に関する追加情報 CAS
1. Investigation Approach:
Impurity Peak Reproduction: Replicating stress conditions within laboratories to reproduce impurity formation and increase corresponding chromatographic peaks. Peak Recognition: Optimizing chromatographic methods to resolve and identify the peak of interest.2. MS (Mass Spectrometry) Experiments:
MS and MS2 Experiments: Conducting mass spectrometry scans on the sample to identify ionizable species present under the peak, followed by fragmentation experiments on selected parent ions to hypothesize molecular structure.3. Confirmatory Experiments:
Assaying putative identities using commercially available standards and customized analytical methods.4. Impurity Isolation:
Evaluating the feasibility of preparative method scale-up, performing isolation cycles, and providing NMR characterization when needed.5. Toxicological Risk Assessment:
Classifying impurities based on ICH M7 guidelines for hazard assessment involving database searches for carcinogenicity and bacterial mutagenicity data.6. In Silico Prediction:
Utilizing in silico QSAR predictors for predicting toxicological profiles when relevant data from literature is not available.7. Permitted Daily Exposure (PDE) Determination:
Deriving PDE for systemic toxicity based on substance-specific doses is unlikely to cause adverse effects with daily exposure over a lifetime.8. Margin Of Safety (MOS):
Comparing PDE with Maximum Daily Intake (MDI) to determine MOS and associated toxicological concerns.説明
Impurity profiling is a critical aspect of pharmaceutical manufacturing | ensuring the quality and safety of drug products. The identification and characterization of unknown impurities are essential steps in this process | as they can pose potential health risks to patients. Here?s an overview of the techniques and procedures used for structural elucidation of unknown impurities in pharmaceutical products: We employ a range of methods to separate impurities from your compound. Prior to purification | we may conduct experiments to enhance impurity levels through forced degradation reactions. Our goal is to purify or isolate the compound using techniques such as liquid-liquid extraction | normal phase or reversed-phase purification | semi-preparative HPLC | crystallization | etc. | to obtain sufficient quantities of the impurity (ies). This will enable us to conduct analyses for their structural elucidation.
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