Loratadine Impurity J

Product Information

• Product Code：L019010

• English Name：Loratadine Impurity J

• English Alias：4,8-dichloro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11(6H)-one

• CAS No.：133330-60-6

• 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, suitable for Loratadine impurity analysis and quality control.

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

Applications

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

• Process Optimization Research：Monitors impurity formation during Loratadine synthesis, reducing generation by >30% by adjusting chlorination temperature (e.g., 50-60℃) and reaction time.

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

Background Description

Research Status

• Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 7 minutes, with LOD of 0.005 ng/mL for trace impurity analysis.

• Formation Mechanism：Formed by electrophilic substitution of benzocycloheptapyridinone with chlorinating agents (e.g., phosphorus oxychloride); optimizing chlorinating agent dosage and reaction pH inhibits side reactions.

• Safety Evaluation：In vitro cytotoxicity shows IC?? of 195.6 μM against Hela cells (Loratadine IC??=12.3 μM), with lower toxicity than the main drug but requiring strict content control. Long-term stability testing is ongoing to monitor degradation under high temperature and humidity 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!