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Rosuvastatin Calcium Ip API

Name of Product Rosuvastatin Calcium Ip
CAS No 147098-20-2
Therapeutic use:- General Api
Grade BP/USP
Form:- API Powder
Status Commercial

Product Overview

Rosuvastatin Calcium IP API is a high-quality powder that is generally white or off-white in colour.

It is designed to meet Indian Pharmacopoeia standards, making it a trusted active ingredient in solid oral dosage forms.

This API undergoes strict quality checks. It has a uniform particle profile and is widely accepted in regulated global markets.

Therapeutic Applications

Rosuvastatin Calcium IP API is used for developing lipid-regulating solid oral formulations.

It is part of the statin chemical class and works well for tablet and combination product development.

This API helps create formulation pipelines. It ensures steady purity and stability, and meets regulatory requirements for long-term production and global supply.

Specification Parameters

The specification parameters protect the purity of Rosuvastatin Calcium IP.

They ensure quality, meet regulations, and fit different formulations.

  • Chemical Name (IUPAC): Calcium bis[(3R,5S,6E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-(methyl(methylsulfonyl)amino)pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoate]

  • CAS Number: 147098-20-2

  • Molecular Formula: C₄₄H₅₄CaF₂N₆O₁₂S₂

  • Appearance: White to off-white crystalline powder

  • Identification Tests: IR spectroscopy, HPLC retention time

  • Assay Method: HPLC

  • Assay: Typically ≥ 99.0% (on a dried basis)

  • Related Substances / Impurities: Managed based on IP monograph limits.

  • Residual Solvents: Complies with ICH Q3C guidelines

  • Elemental Impurities: Complies with ICH Q3D requirements.

  • Loss on Drying / Water Content: As specified in IP limits.

  • Microbial limits: Not applicable (N/A) for API grade

      Packaging & Storage

      Rosuvastatin Calcium IP bulk API is packed securely in HDPE, fiber, or cardboard drums.

      Each package usually contains 25 kg. Store the material in a cool, dry place.

      Keep it away from light and heat. Make sure containers are tightly closed.

      Why Choose Us

      Actiza Pharma provides trusted Rosuvastatin Calcium IP API.

      We ensure high-quality global supply support and customer-focused manufacturing.

      Quality Focus

      We follow a strict quality system to produce our Rosuvastatin Calcium IP API.

      Every batch is checked to ensure it meets IP standards and our validated processes.

      So, you can rely on it being pure, consistent, and performing well in your formulations.

      Advanced Facilities

      We operate modern, automated manufacturing units with controlled environments.

      Dedicated zones, clean utilities, and skilled teams help ensure the safe production of APIs.

      We also maintain stability, traceability, and regulatory readiness.

      Global Compliance

      Actiza Pharmaceutical Pvt. Ltd. caters to various market requirements with documents that meet IP and global standards.

      Our systems help customers easily meet regulatory expectations and manage both local and global supply chains with confidence.

      Reliable Supply

      We have solid backward integration and a strong network of vendors.

      This helps us keep stock levels full, provide flexible ordering, and ensure fast delivery.

      Our customer support team helps you from your first question to order dispatch.