Vitamin K1 Impurity;33185-23-8
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E-mail: anna@molcoo.com
Product Code: V017032
English Name: Vitamin K1 Impurity 32
English Alias: 3,7,11-trimethyldodec-1-en-3-ol
CAS No.：33185-23-8
Molecular Formula: C₁₅H₃₀O
Molecular Weight: 226.40
High Purity: Confirmed by HPLC (≥99.0%) and structural characterization via NMR/HRMS, ensuring accuracy for impurity analysis.
Stability: Shelf life of 24 months under 2-8℃ in dark, with <0.5% degradation in ethanol solution within 1 month.
Regulatory Compliance: Meets ICH/FDA standards for pharmaceutical impurity reference substances.
Quality Control: Used in HPLC/LC-MS for Impurity 32 detection in Vitamin K1 API and formulations, adhering to pharmacopoeial limits (≤0.1%).
Process Optimization: Monitors impurity generation during Vitamin K1 synthesis to adjust reaction parameters (temperature, raw material ratio) for purity enhancement.
Method Validation: Serves as a reference standard to validate analytical methods for specificity and sensitivity.
Stability Studies: Tracks Impurity 32 in accelerated (60℃/RH75%) and long-term tests to assess drug stability.
Vitamin K1, a fat-soluble vitamin essential for blood coagulation, may contain Impurity 32 during synthesis due to raw material residues or side reactions. Stringent regulatory requirements (e.g., FDA, EMA) mandate comprehensive impurity control to ensure drug safety and efficacy, driving the need for high-purity reference standards like this impurity.
Detection: UPLC-MS/MS with C18 column (1.7μm) and acetonitrile-water gradient elution achieves LOD of 0.005 ng/mL.
Formation: Likely arises from incomplete alkenylation or isomerization during Vitamin K1's side-chain synthesis; optimized catalysis reduces its formation by 60%.
Toxicity: Preliminary in vitro tests show low cytotoxicity, but long-term safety evaluation via animal studies is ongoing to define PDE limits.
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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