Vitamin K1 Impurity;29171-23-1
Product Code: V017031
English Name: Vitamin K1 Impurity 31
English Alias: 3,7,11,15-tetramethylhexadec-1-yn-3-ol
CAS No.：29171-23-1
Molecular Formula: C₂₀H₃₈O
Molecular Weight: 294.52
High Purity and Structure Confirmation: With a purity of ≥99.0% detected by HPLC, its structure is confirmed by NMR, HRMS and other techniques, providing a precise and reliable reference standard for the analysis of Vitamin K1 impurities.
Good Stability: Under the storage conditions of 2 - 8°C in the dark and dry environment, the shelf life can reach 24 months, and the degradation rate in solution (such as ethanol) is less than 0.5% within 1 month, ensuring the stability of experimental data.
Compliance Assurance: Strictly produced in accordance with international pharmaceutical regulatory standards such as ICH and FDA, meeting the regulatory requirements of pharmaceutical companies in drug research and development, quality control and application processes.
Quality Control Testing: Used for the detection of Impurity 31 in Vitamin K1 active pharmaceutical ingredients and formulations by HPLC, LC - MS, etc., strictly controlling the impurity content to ensure that the product quality meets the pharmacopoeia and relevant regulatory standards.
Process Optimization: During the synthesis of Vitamin K1, monitor the generation of Impurity 31. Adjust process parameters such as reaction temperature, raw material ratio, and reaction time to reduce the amount of impurities generated and improve product purity.
Analytical Method Validation: As a reference standard for the development and validation of Vitamin K1 impurity detection methods, evaluate the specificity, sensitivity and repeatability of the methods, and provide reliable analytical means for quality control.
Stability Studies: Track the content changes of Impurity 31 in accelerated stability tests (such as 60℃/RH75%) and long - term stability tests, analyze its impact on drug stability, and provide data support for determining the storage conditions and shelf life of drugs.
Vitamin K1 is an important fat - soluble vitamin that plays a key role in physiological processes such as blood coagulation and bone health. It is commonly used to treat vitamin K deficiency and other diseases. During the production of Vitamin K1, various impurities may be generated due to factors such as raw material purity, reaction conditions, and synthesis processes, and Impurity 31 is one of them. With the continuous improvement of global requirements for drug quality and safety, pharmaceutical regulatory agencies around the world have become increasingly strict in controlling impurities in Vitamin K1, requiring comprehensive research on impurities and the establishment of strict limit standards. Therefore, the research and control of Vitamin K1 Impurity 31 have become an important part of ensuring drug quality and patient medication safety.
Detection Technology: Currently, UPLC - MS/MS technology is mainly used to detect Impurity 31. By optimizing the chromatographic column (such as C18 column, 1.7μm particle size), mobile phase system (acetonitrile - water gradient elution) and mass spectrometry parameters (electrospray ionization source, multiple reaction monitoring mode), highly sensitive detection of impurities can be achieved, with a detection limit as low as 0.003 ng/mL.
Formation Mechanism: Research shows that Impurity 31 may originate from side reactions in the carbon - chain construction or alkynyl introduction steps during the synthesis of Vitamin K1, or from the incomplete reaction and conversion of related unsaturated alcohol substances in raw materials. By improving the synthesis process, such as optimizing catalyst selection and precisely controlling reaction conditions, the generation of Impurity 31 can be effectively reduced.
Safety Evaluation: The safety research on Impurity 31 is still in the preliminary stage. In vitro cell experiments show that it has a certain impact on some cell lines at high concentrations, but the specific toxic mechanism is still unclear. Currently, the limit set in drug quality standards is ≤0.1%. Further animal experiments and pre - clinical studies are needed to deeply explore its toxic characteristics and improve the impurity control strategy.
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NOTE！
We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.
This product is intended for laboratory use only!
WhatsAPP: +86 17320513646
E-mail: anna@molcoo.com
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