Clopidogrel IR Pellets Manufacturer in India

Clopidogrel IR Pellets

Clopidogrel IR Pellets are pharmaceutical-grade immediate-release multiparticulate pellets containing clopidogrel as the active pharmaceutical ingredient. These pellets are designed for oral formulation applications where an immediate-release pellet format is required for capsule filling, multiparticulate formulation development and other solid oral dosage applications.

Clopidogrel is commonly supplied as Clopidogrel Bisulfate, with CAS Number 120202-66-6, molecular formula C₁₆H₁₆ClNO₂S·H₂SO₄ and molecular weight 419.90 g/mol. The USP definition for Clopidogrel Bisulfate specifies 97.0% to 101.5% on a dried basis for the active pharmaceutical ingredient. This API specification should not be confused with the assay/loading of the finished pellets.

Clopidogrel IR Pellets are available commercially in different active loading levels. Published pharmaceutical pellet portfolios document 50% w/w as a commonly available strength, while other commercial portfolios report additional loadings.

For the SDP product page, the finished-pellet strength should be stated only according to the applicable SDP product specification or COA. If the SDP product is the commonly listed 50% w/w presentation, it can be displayed as Clopidogrel IR Pellets 50% w/w.

Pharmaceutical-Grade Clopidogrel IR Pellets

Clopidogrel IR Pellets provide a multiparticulate format that can support formulation flexibility. Compared with a conventional single-unit dosage form, pellet systems allow the active ingredient to be distributed among multiple individual particles. The pellets can be used for capsule-filling applications and can also be incorporated into other multiparticulate formulation approaches.

Important finished-product characteristics can include active ingredient loading, particle-size distribution, bulk density, tapped density, moisture, friability, pellet morphology, content uniformity and immediate-release dissolution performance.

The final specifications should be established specifically for the finished Clopidogrel IR Pellets. API specifications such as the USP assay of 97.0–101.5% should not be copied directly into the finished-pellet specification because the pellet contains the active ingredient together with pellet excipients and processing materials.

Applications

Clopidogrel IR Pellets can be considered for:

• Immediate-release oral formulations
• Multiparticulate formulations
• Capsule-filling applications
• Pharmaceutical formulation development
• Pellet-based oral dosage systems
• Bulk pharmaceutical formulation
• Pharmaceutical research and development

Key Product Characteristics

The finished Clopidogrel IR Pellet system can be evaluated for:

• Active ingredient loading
• Identification
• Assay
• Content uniformity
• Particle-size distribution
• Moisture / loss on drying
• Bulk density
• Tapped density
• Friability
• Pellet morphology
• Flow properties
• Dissolution performance
• Microbiological quality where applicable

Why Clopidogrel IR Pellets from Swapnroop?

• Pharmaceutical-Grade Pellets – Developed for pharmaceutical formulation applications.
• Immediate-Release Format – Designed for immediate-release multiparticulate formulations.
• Defined Active Loading – 50% w/w can be offered where confirmed by the applicable product specification.
• Multiparticulate System – Suitable for formulations requiring multiple discrete pellet units.
• Capsule-Filling Applications – Suitable for pellet-based capsule formulation.
• Controlled Pellet Characteristics – Particle size and physical parameters can be specified according to product requirements.
• Formulation Flexibility – Suitable for pharmaceutical formulation development.
• Bulk Pharmaceutical Supply – Suitable for commercial formulation requirements.
• Manufacturer & Supplier Support – Suitable for pharmaceutical formulation and bulk requirements.

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