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Product Information |
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Product name |
Racecadotril |
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CAS No. |
81110-73-8 |
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Molecular Formula |
C21H23NO4S |
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Molecular Weight |
385.484 |
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Quality Standard |
EP/CEP |
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Appearance |
White to almost white powder |
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COA |
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Test Items |
Specifications |
Results |
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Appearance |
White to almost powder |
White powder |
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IR Identification |
Complies with the standard spectrum |
Conforms |
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Appearance of solution |
limpid solution; ≤Y6 reference colormetric solution |
Conforms |
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Related substances (by HPLC) |
Impurity A:<0.1 % |
< 0.05% |
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Impurity C: ≤0.2% |
< 0.05% |
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Impurity E:<0.2% |
< 0.05% |
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Impurity F:≤0.2% |
< 0.05% |
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Individual unspecified impurities:≤0.10 % |
< 0.05% |
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Total impurities: ≤0.5 % |
< 0.10% |
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Loss on drying |
≤0.5% |
0.1% |
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Sulfated ash |
≤0.1% |
0.04% |
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Assay (by HPLC) |
98.0% - 102.0% |
100.2% |
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Conclusion |
It conforms to EP11.0 |
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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.