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Racecadotril 81110-73-8

Racecadotril 81110-73-8

EP, CEP
  • Product Details

Product Information

 

Product name

Racecadotril

CAS No.

81110-73-8

Molecular Formula

C21H23NO4S

Molecular Weight

385.484

Quality Standard

EP/CEP

Appearance

White to almost white powder

 

COA

 

Test Items

Specifications

Results

Appearance

White to almost powder

White powder

IR Identification

Complies with the standard spectrum

Conforms

 

Appearance of solution

limpid solution; 

Y6 reference colormetric solution

Conforms

 

Related substances

(by HPLC)

Impurity A:<0.1 %

< 0.05%

Impurity C: 0.2%

< 0.05%

Impurity E:<0.2%

< 0.05%

Impurity F:0.2%

< 0.05%

Individual unspecified impurities:0.10 %

< 0.05%

Total impurities: 0.5 %

< 0.10%

Loss on drying

0.5%

0.1%

Sulfated ash

0.1%

0.04%

Assay (by HPLC)

98.0% - 102.0%

100.2%

Conclusion

It conforms to EP11.0

 

Usage

 

1. Brief Function of Racecadotril

(1) Core Function: An efficient and safe antisecretory antidiarrheal agent.

(2) Mechanism of Action (Key Difference from Common Antidiarrheals):

It does not inhibit intestinal motility (unlike loperamide, which "stops" bowel movement) nor does it kill pathogens (unlike antibiotics). Acts as an enkephalinase inhibitor, it blocks the enzyme that breaks down enkephalins (natural molecules in the gut), thereby reducing the excessive secretion of water and electrolytes that causes watery diarrhea. Besides, it does not paralyze the gut or trap pathogens, making it a safer option, especially for children with acute infectious diarrhea.

(3) Main Characteristics: Rapid onset (within 1 hour), high safety profile (minimizing constipation risk), targets the cause of secretion.

 

2. Advantages of China's Manufacturing Process for Racecadotril

As a major global producer of Active Pharmaceutical Ingredients (APIs), China holds significant advantages in the manufacturing of Racecadotril, primarily reflected in cost, supply chain, and process optimization.

(1) Complete Industrial Chain and Cost Advantages:

A complete domestic chemical industry ensures easy access to raw materials. Large-scale manufacturing achieves significant cost savings through economies of scale.

(2) Optimized Process

Efficient Synthetic Route: Synthesis routes are highly optimized for better yield and purity, incorporating greener technologies for environmental compliance.

(3) Strict Quality Control Aligned with International Standards:

Leading manufacturers operate under international GMP standards, using advanced analytical techniques (e.g., HPLC, GC-MS) to guarantee high-purity (>99.5%), low-impurity API for global markets.

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If you are interested in our products and want to know more details,please leave a message here,we will reply you as soon as we can.

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