Product Certification&
Enterprise Certification
Country: China (Mainland)
Business Type:Lab/Research institutions
Tel: +86-173-20513646
Mobile: 17320513646
Tel: +86-173-20513646
Fax:
Province/state: Hu Bei
City: Wuhan
Street: Company address: Room 005, 15th Floor, Building D2, Phase III, Software New Town, No. 8 Huacheng Avenue, East Lake High-tech Development Zone, Wuhan, Hubei Province, China
MaxCard:
CAS NO.26360-21-4
1(10.0-10000)Milligram
Advantages
High-Purity Guarantee:Confirmed by HPLC with a purity of ≥99.0%, and the structure is verified through multiple methods including NMR (1H, 13C), HRMS, and elemental analysis, providing an accurate and reliable reference standard for N-Nitroso Folic Acid related research.
Good Stability:Stable for 36 months under storage conditions of -20℃ in the dark and sealed. The degradation rate is less than 0.3% within 6 months in common solvent systems such as methanol - water mixtures, ensuring stable and reliable experimental data.
N-Nitroso Folic Acid? ;26360-21-4
WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com
Product Information
Product Code:N031100
English Name:N-Nitroso Folic Acid
English Alias:(S)-2-(4-(((2-amino-4-oxo-1,4-dihydropteridin-6-yl)methyl)(nitroso)amino)benzamido)pentanedioic acid
CAS No.:26360-21-4
Molecular Formula:C??H??N?O?
Molecular Weight:470.4
Advantages
High-Purity Guarantee:Confirmed by HPLC with a purity of ≥99.0%, and the structure is verified through multiple methods including NMR (1H, 13C), HRMS, and elemental analysis, providing an accurate and reliable reference standard for N-Nitroso Folic Acid related research.
Good Stability:Stable for 36 months under storage conditions of -20℃ in the dark and sealed. The degradation rate is less than 0.3% within 6 months in common solvent systems such as methanol - water mixtures, ensuring stable and reliable experimental data.
Applications
Quality Control Testing:Used for UPLC-MS/MS detection of N-Nitroso Folic Acid impurity in Folic Acid API and formulations. Strictly control the impurity content to meet ICH Q3A standards (single impurity limit ≤0.1%), ensuring drug quality and safety.
Drug Research:As a reference substance for studying the effects of nitrosation on the activity and metabolism of folic acid, exploring the potential toxicity mechanism of N-Nitroso Folic Acid in vivo, and providing a basis for the safety evaluation of folic acid-based drugs.
Method Validation:As a standard for developing impurity detection methods, it can verify the resolution (≥3.0) and limit of detection (0.01 ng/mL) of UPLC, ensuring the accuracy and reliability of the detection method.
Background Description
Folic acid, an important B-vitamin, plays a crucial role in cellular DNA synthesis, repair, and methylation reactions. It is widely used in preventing fetal neural tube defects and treating megaloblastic anemia. N-Nitroso Folic Acid, a nitrosated derivative of folic acid formed under specific conditions (such as acidic environments or in the presence of nitrites), may have its biological activity altered and potential toxicity increased due to the nitroso group in its structure. With the increasing requirements for drug safety, the study of N-Nitroso Folic Acid impurity has become an important part of ensuring the quality and safety of folic acid-based drugs.
Research Status
Detection Technology:UPLC-MS/MS technology is used, combined with a C18 column (1.7μm) and gradient elution with 0.1% formic acid - acetonitrile. Impurities can be separated within 8 minutes, and the limit of detection is as low as 0.003 ng/mL, enabling high-precision detection of trace N-Nitroso Folic Acid.
Formation Mechanism:Studies have shown that folic acid reacts with nitrites under acidic conditions (pH < 4), and the amino group is easily nitrosated to form N-Nitroso Folic Acid. By controlling the pH during the production of folic acid formulations and reducing the introduction of nitrites, the formation of this impurity can be effectively inhibited.
Safety Evaluation:Animal experiments have shown that N-Nitroso Folic Acid has potential genotoxicity and can cause DNA damage. Currently, more in vitro and in vivo studies are being carried out to clarify its impact on human health, providing data support for formulating stricter impurity control standards.