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Postion:Product Catalog >Analytical Chemistry>Standard>Pharmaceutical Impurity Reference Standards>Loratadine Impurity
Loratadine Impurity
  • Loratadine Impurity
  • Loratadine Impurity
  • Loratadine Impurity
  • Loratadine Impurity
  • Loratadine Impurity

Loratadine Impurity NEW

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

Product Details

Product Name: Loratadine Impurity CAS No.: 133330-61-7
Min. Order: 10mg Purity: 99%+ HPLC
Supply Ability: 1000 Release date: 2025/07/31

Loratadine Impurity 

Article illustration



  • Product Information

  • Product Code:L019035

  • English Name:Loratadine Impurity 35

  • English Alias:2,8-dichloro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11(6H)-one

  • CAS No.:133330-61-7

  • Molecular Formula:C??H?Cl?NO

  • Molecular Weight:278.13

  • Advantages

  • High-Purity Reference Standard:Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, providing a reliable standard for Loratadine impurity analysis.

  • Stability Assurance:Stable for 36 months under storage at -20℃ in the dark and sealed. The degradation rate is less than 0.3% within 6 months in methanol - water mixture, ensuring stable and repeatable experimental data.

  • Applications

  • Quality Control Testing:Used for UPLC-MS/MS detection of Impurity 35 in Loratadine API and formulations, strictly controlling impurity content to meet ICH Q3A standards (single impurity limit ≤0.1%).

  • Process Optimization Research:Monitor the formation pathway of this impurity during Loratadine synthesis. By adjusting parameters such as chlorination reaction temperature (e.g., 40 - 50℃) and reaction time, the generation of impurities can be reduced by more than 35%.

  • 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 sensitivity of the detection method.

  • Background Description

  • Loratadine, a second-generation antihistamine, exerts a lasting effect on peripheral H1 receptors and is commonly used to relieve symptoms of allergic rhinitis, chronic urticaria, etc. Impurity 35, a process-related impurity in Loratadine synthesis, may originate from side reactions during the chlorination of the benzocycloheptapyridine nucleus. Its dichloro substituents and carbonyl group may affect the drug's physical and chemical properties, pharmacokinetics, and safety. Given that antihistamines act directly on the human immune system, strict control of impurities is crucial for ensuring drug quality and patient safety.
  • Research Status

  • Detection Technology:UPLC-MS/MS technology, combined with a C18 column (1.7μm) and gradient elution with 0.1% formic acid - acetonitrile, achieves impurity separation within 6 minutes, with a detection limit as low as 0.003 ng/mL for high-precision trace impurity detection.

  • Formation Mechanism:Studies show that this impurity is formed by the electrophilic substitution reaction of benzocycloheptapyridinone intermediates with chlorinating agents such as phosphorus trichloride or chlorine gas. Optimizing the dosage of chlorinating agents, reaction pH, and reaction time can effectively inhibit its formation.

  • Safety Evaluation:In vitro cytotoxicity experiments show that the IC?? of this impurity against L929 cells is 187.4 μM (Loratadine IC?? = 11.2 μM). Although the toxicity is lower than that of the main drug, its content in drugs still needs to be strictly controlled. Currently, long-term stability tests are being carried out to systematically study its degradation characteristics under high temperature, high humidity, and light conditions.


  • WhatsAPP: +86 17320513646
    E-mail: anna@molcoo.com


    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


    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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