Impurities are substances that affect the purity of drugs or finished products and can impact the efficacy, safety, and quality of pharmaceutical products. They may appear at any stage of synthesis, formulation, purification, or storage. As a trusted manufacturer and supplier in Hyderabad, India, Manasa Life Sciences provides APIs, intermediates, and high-quality reference standards with complete documentation and global regulatory compliance.

At Manasa Life Sciences, we employ advanced analytical techniques to detect and quantify impurities in pharmaceutical substances. Our capabilities include Gas Chromatography (GC) and High-Performance Liquid Chromatography (HPLC) for precise separation and quantification, Ultraviolet (UV) and Infrared (IR) Spectroscopy for structural and functional group analysis, Nuclear Magnetic Resonance (NMR) Spectroscopy for detailed molecular characterization, and Mass Spectrometry (MS) for highly accurate mass determination. These state-of-the-art methods ensure reliable impurity profiling, regulatory compliance, and high-quality pharmaceutical products.

We implement comprehensive quality audits, monitoring, and ICH Q3A-compliant processes to minimize impurities throughout production. This ensures safe, effective, and high-quality pharmaceutical products for clients worldwide. We supply to Asia, Europe, Africa, the GCC, and UAE markets, ensuring reliable delivery, full traceability, and adherence to Good Documentation Practices (GDP) for impurities.

Impurities are undesirable compounds that may remain with APIs during formulation. If their levels exceed acceptable limits, they can lead to unintended pharmacological or toxicological effects. They may arise from raw materials, chemical reagents, intermediates, atmospheric contamination, storage conditions, drug degradation, or microbial contamination. Impurities are addressed at all stages of API manufacturing and drug formulation to ensure the highest quality standards.

Types of Impurities

  • Impurities in APIs are broadly classified into three categories:
  • Organic Impurities
  • Originate from starting materials, by-products, intermediates, or degradation products.
  • Identified as volatile, non-volatile, or unknown compounds and analyzed for chemical structure and safety.
  • Controlled according to ICH guidelines, with thorough evaluation during synthesis.
  • Inorganic Impurities
  • Arise from reagents, salts, heavy metals, or catalysts used in manufacturing.
  • Quantified using pharmacopeial or validated methods, with strict adherence to safety limits.
  • Residual Solvents
  • Also called organic volatile contaminants, remaining from API, excipient, or finished product manufacturing.
  • Classified as undesirable substances and controlled even at trace levels.
  • Identified and quantified using Gas Chromatography (GC), following ICH Q3C guidelines.
  • Control and Monitoring of Impurities

Organic impurities: Monitored through raw material evaluation, reaction intermediates, stress testing (ICH Q1A), and batch analysis during process development and commercial production.

Inorganic impurities: Assessed for catalyst carry-over and other contaminants using pharmacopeial methods, with acceptance criteria based on safety and regulatory standards.

Residual solvents: Controlled through validated manufacturing processes in compliance with ICH Q3C guidelines.

Disadvantages of Impurities

  • Reduce shelf life of the finished product
  • Complicate formulation and processing
  • Affect the purity and potency of APIs
  • Cause changes in physical properties (color, odor, taste) due to instability or hygroscopic nature

 

Filter sub products categories alphabetically

Displaying 1 - 20 of 583 sub product categories