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Postion:Product Catalog >N-Nitroso Bromhexine EP Impurity E
N-Nitroso Bromhexine EP Impurity E
  • N-Nitroso Bromhexine EP Impurity E
  • N-Nitroso Bromhexine EP Impurity E
  • N-Nitroso Bromhexine EP Impurity E
  • N-Nitroso Bromhexine EP Impurity E
  • N-Nitroso Bromhexine EP Impurity E

N-Nitroso Bromhexine EP Impurity E NEW

Price Get Latest Price
Package 10mg 50mg 100mg
Min. Order: 10mg
Supply Ability: 1000
Update Time: 2025-07-31

Product Details

Product Name: N-Nitroso Bromhexine EP Impurity E Min. Order: 10mg
Purity: 99%+ HPLC Supply Ability: 1000
Release date: 2025/07/31

N-Nitroso Bromhexine EP Impurity E

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WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com



  • Product Information

  • Product Code:B008035

  • English Name:N-Nitroso Bromhexine EP Impurity E

  • English Alias:6,8-dibromo-3-cyclohexyl-3-methyl-1-nitroso-1,2,3,4-tetrahydroquinazolin-3-ium

  • CAS No.:Not provided (to be supplemented)

  • Molecular Formula:C??H??Br?N?O

  • Molecular Weight:418.15

  • Advantages

  • High-Purity Reference Standard:Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Bromhexine EP nitroso impurity analysis and quality control.

  • Stability Assurance:Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in methanol-water mixture within 6 months.

  • Applications

  • Quality Control Testing:Used for UPLC-MS/MS detection of EP Impurity E in Bromhexine API and formulations, meeting EP and ICH Q3A standards (single impurity limit ≤0.1%).

  • Process Optimization Research:Monitors impurity formation during Bromhexine synthesis, reducing generation by >40% by adjusting nitrosation temperature (e.g., 0-5℃) and pH.

  • Method Validation:Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.01 ng/mL).

  • Background Description

  • Bromhexine, a mucolytic agent, is used for treating respiratory diseases like chronic bronchitis by reducing sputum viscosity. Impurity E, as a nitroso impurity specified in EP, may originate from side reactions between amino groups and nitrites during synthesis. Its nitroso, bromine, and quinazoline groups may affect drug stability, solubility, and safety. As EP imposes mandatory control over drug impurities in the European market, studying this impurity is crucial for ensuring Bromhexine's international quality.
  • Research Status

  • Detection Technology:UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 8 minutes, with LOD of 0.005 ng/mL to meet EP trace analysis requirements.

  • Formation Mechanism:Formed by nitrosation of Bromhexine intermediates with nitrites under acidic conditions (e.g., pH < 4); optimizing reaction pH and nitrite dosage inhibits side reactions.

  • Safety Evaluation:In vitro cytotoxicity shows IC?? of 195.6 μM against A549 cells (Bromhexine IC??=10.2 μM), with lower toxicity than the main drug but requiring content control. Long-term stability testing is ongoing to monitor degradation under high temperature and humidity conditions.


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 17386083646
E-mail: anna@molcoo.com


NEW IN STOCK!

The Molcoo Laboratory added drug impurity reference standards, including Baricitinib, Piperazine, Benzylpenicillin, Tranilast and multiple N-Nitroso drug impurities! Now available for immediate delivery! 








Company Profile Introduction

1. Drug standards and drug impurity reference substances: provide more than 20,000 kinds of spot impurity reference substances, with sufficient supply and same-day delivery. We have a professional R&D team and comprehensive quality control testing to ensure product quality and reliability. 2. Customized synthesis of impurities and new molecules: Quickly respond to the customized needs of CDE impurities, stably supply impurities that have established quality standards, and provide customized synthesis services for new compounds in the research and development of innovative drugs. 3. Preparation and separation of unknown impurities: With a professional impurity preparation and separation technical team and SFC preparation and separation instruments, we can solve the problems of impurity preparation in complex projects. 4. Process development of new drug intermediates: provide the supply of new drugs and new molecular impurities, process optimization services, as well as the screening and impurity analysis of commercialization routes. 5. Peptide synthesis: Provide customized peptide synthesis services, and cover all kinds of degradation impurities and process impurities generated in the research and development of peptide drugs. At the same time, it provides comprehensive structural confirmation data and customized testing services.

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