About Esomeprazole Magnesium Pellets
Esomeprazole Magnesium Pellets
- Other Name : magnesium; 5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]benzimidazol-1-ide; 5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]benzimidazol-1-ide
- CAS Number : 161973-10-0
- Molecular Formula : 2(C17H18N3O3S)2.Mg
- Application : Antiulcerative
Superior Gastro-Resistant PelletsThese esomeprazole magnesium pellets feature robust enteric coating, rendering them gastro-resistant and stable under pharmaceutical processing conditions. Tailored for delayed-release oral formulations, they ensure effective, targeted delivery to the intestine. Their spherical shape and particle size between 200 and 800 microns facilitate superior blending and handling during tablet or capsule manufacturing.
Quality and Compliance AssuredManufactured in strict accordance with pharmacopoeial guidelines (IP/USP/EP), each batch undergoes rigorous quality control tests for purity, heavy metal content, microbial limits, and physical characteristics. Pellets are supplied in pharmaceutical grade purity (99%) and are stable for up to 36 months under recommended storage conditions.
FAQs of Esomeprazole Magnesium Pellets:
Q: How should Esomeprazole Magnesium Pellets be stored and transported?
A: These pellets must be stored in a cool, dry place, protected from light and moisture. Transport should be in tightly sealed HDPE drums, lined with double polyethylene bags, to maintain stability and prevent contamination.
Q: What is the manufacturing process for these pellets?
A: Esomeprazole Magnesium Pellets are produced using a non-pelletizing process followed by enteric coating. This unique method ensures the pellets are gastro-resistant and suitable for delayed-release pharmaceutical formulations.
Q: When and where are these pellets typically used?
A: These pellets are used during the formulation stage for manufacturing delayed-release tablets and capsules. They are widely utilized by pharmaceutical companies, distributors, and manufacturers dealing with acid-related disorders.
Q: What is the application and therapeutic benefit of these pellets?
A: The pellets are formulated into oral dosage forms to treat acid-related conditions such as GERD and peptic ulcers. Their gastro-resistant property allows the drug to bypass the stomach and release in the intestine, enhancing therapeutic efficacy.
Q: How do the quality control standards ensure product safety?
A: Each batch complies with pharmacopoeial standards (IP/USP/EP), including limits for heavy metals (10 ppm), microbial presence, and high purity (99%). Strict adherence to these standards ensures safe and effective pharmaceutical ingredients.
Q: Why is the particle size and bulk density important in these pellets?
A: Particle size (200800 microns) and bulk density (0.450.75 g/ml) are critical for uniform blending during tablet or capsule production, achieving consistent dosage forms, and ensuring reliable performance in final pharmaceutical products.