How is Glibenclamide Sulfonamide(Intermediate) Manufactured?
Glibenclamide Sulfonamide is a sulfonylurea-based pharmaceutical intermediate used in the synthesis of Glibenclamide (Glyburide), an oral antidiabetic agent. It is not an active pharmaceutical ingredient but serves as a crucial structural component during API formation.
The quality of pharmaceutical intermediates plays a critical role in the downstream manufacturing process. Inadequate purity, inconsistent parameters, or non-compliance with manufacturing standards can compromise the safety, efficacy, and regulatory acceptance of the final drug product.
Overview of Glibenclamide Sulfonamide as a Key Intermediate
Glibenclamide Sulfonamide falls under the sulfonylurea intermediates used in the formulation of Glibenclamide. It plays a structural role in the synthesis pathway, serving as a building block in the stepwise chemical process.
Chemical Profile:
- Molecular Formula: C16H17ClN2O4S
- Physical Form: White to yellowish crystalline powder
This intermediate is typically required by API manufacturers, CDMOs, and generic formulation companies. It is used during early to mid-synthesis stages and must meet stringent impurity limits and characterization requirements. It is widely used by pharmaceutical exporters and generic drug manufacturers who require a reliable and scalable intermediate supply.
Ensuring Purity and Quality Compliance
Analytical Testing Protocols
Each batch of Glibenclamide Sulfonamide is tested for identity, purity, and consistency. HPLC is used for assay and impurity profiling. NMR and IR confirm structural integrity. Melting point, loss on drying (LOD), and particle size distribution are recorded.
Residual solvents are analyzed using GC as per ICH guidelines. Limits for Class 1, 2, and 3 solvents are strictly followed. Impurity thresholds are kept within pharmacopeial limits or client-specific specifications.
A Certificate of Analysis (CoA) is issued for every batch, including complete analytical data, specifications, and release criteria.
Regulatory Documentation
Supporting documentation includes:
- MSDS: For safe handling, transport, and storage
- CoA: Batch-specific quality confirmation
- Stability Data: If required for long-term storage or export
- Regulatory Support: Includes REACH registration and USDMF (if applicable)
These documents are provided to facilitate qualification and regulatory filings for clients operating in regulated markets.
Manufacturing Standards and Compliance
Manufacturing of Glibenclamide Sulfonamide follows defined internal quality protocols. Processes are structured to maintain consistency, material traceability, and documentation standards from the stage the intermediate is classified as an API Starting Material. Batch-wise controls and detailed records are maintained to support technical audits and meet international compliance expectations.
India’s Revised Schedule M (2023–2024) outlines updated quality requirements for pharmaceutical manufacturers, including principles of Quality Risk Management (QRM), ALCOA+ data integrity standards, equipment qualification frameworks, and improved quality system oversight. These guidelines help ensure traceable, well-documented production aligned with regulatory needs for intermediates intended for use in regulated markets.
Each production batch is assigned a unique identification code. Cleaning and equipment usage logs are maintained. Environmental conditions are monitored in controlled areas to prevent contamination and cross-contamination, with specific controls and procedures implemented as appropriate for the stage of manufacture and product sensitivity.
Environmental, Health, and Safety (EHS) protocols are implemented. Waste is treated as per local regulations, and effluents are neutralized before disposal.
Challenges in Manufacturing Glibenclamide Sulfonamide
One of the key challenges in this process is handling sulfonylating agents, which are hazardous and require controlled environments. Reaction steps are sensitive to temperature and time, and deviations can cause byproduct formation.
Maintaining impurity levels below acceptable thresholds is a significant manufacturing challenge. Impurity content above 0.5% can affect API yield and regulatory acceptance. Therefore, purification steps must be rigorously optimized to ensure compliance with quality specifications.
Reproducibility in crystallization and drying is also critical. Variation in particle size or polymorphic form can affect subsequent API processing.
Why Source from a Reliable Intermediate Manufacturer
A consistent and high-quality intermediate supply minimizes the risk of downstream synthesis failures and enhances batch reproducibility. Using well-characterized intermediates improves API synthesis consistency and regulatory compliance.
At PYG Lifesciences, manufacturing is aligned with international quality benchmarks. All intermediates are produced under strict GMP standards, supported with technical documentation. Our focus on local sourcing and trained workforce enables consistent supply at competitive costs.
Working with a trusted partner helps reduce rework, improve batch yield, and accelerate time to market for API manufacturers and CDMOs.
PYG Lifesciences remains committed to delivering pharmaceutical intermediates that align with international regulatory standards and quality benchmarks. Contact us for detailed specifications or partnership inquiries.
