High-Purity API Intermediate with Consistent Quality and Scalable Supply.
Glibenclamide Sulfonamide
Glibenclamide Sulfonamide
(5-Chloro-2-methoxy-N-[2-(4-sulfamoylphenyl)ethyl]benzamide)
- CAS No.: 16673-34-00
- Molecular formula: C₁₆H₁₇ClN₂O₄S
- Molecular Weight: MW ≈ 368.83
- Therapeutic uses: anti diabetic
- Class: Sulfonamide-benzamide intermediate
- Specifications: Pharmaceutical intermediate grade
- Appearance: Off white to light pale yellow colour
- Storage: Cool, dry place; protect from light and moisture
Product overview
Applications of Glibenclamide Sulfonamide
Pharmaceutical Intermediate
Serves as a critical intermediate in the multi-step synthesis of Glibenclamide (Glyburide), a second-generation sulfonylurea oral antidiabetic drug. High assay and controlled impurity levels in this intermediate are essential for ensuring consistent downstream reaction performance, optimal crystallinity of the final API, and regulatory compliance during commercial production. Its purity profile directly impacts the yield, particle morphology, and stability of the finished Glibenclamide API, making it indispensable in maintaining therapeutic quality and bioavailability.
Research & Process Development
Widely adopted in route scouting studies to evaluate synthetic pathways for Glibenclamide and other structurally related sulfonylurea derivatives. Supports impurity fate and mapping investigations, enabling chemists to trace degradation or by-product formation throughout the synthesis process. Used in crystallization optimization and formulation studies to refine particle size distribution, dissolution profile, and scalability. Suitable for scale-up from kilo-lab quantities to pilot and commercial scale, ensuring process reproducibility.
Custom Synthesis Programs (CRAMS/CDMO Integration)
Can be customized as part of Contract Research and Manufacturing Services (CRAMS) or Contract Development and Manufacturing Organization (CDMO) projects. Enables the development of closely related sulfonamide and sulfonylurea building blocks, which are essential for new chemical entity (NCE) development in the antidiabetic category. Supports process optimization initiatives, including impurity reduction, solvent substitution, and yield enhancement, tailored to client specifications.
Regulatory & Analytical Use
Suitable for generating reference standards and conducting method development and validation for Glibenclamide API analysis. Used in stability studies to assess intermediate shelf-life under various storage and packaging conditions. Plays a role in regulatory submissions by enabling data generation for Drug Master Files (DMFs) or Certificate of Suitability (CEP) dossiers.Technical Specifications of Our Glibenclamide Sulfonamide
| Sr. No. | Specification | Details |
| 1 | Chemical Name | Glibenclamide Sulfonamide |
| 2 | Synonyms | (5-Chloro-2-methoxy-N-[2-(4-sulfamoylphenyl)ethyl]benzamide) |
| 3 | CAS Number | 16673-34-00 |
| 4 | Molecular Formula & Weight | (C₁₆H₁₇ClN₂O₄S, MW ≈ 368.83) |
| 5 | Appearance | Off white to light pale yellow colour |
| 6 | Assay (HPLC) | NLT 98.0% (typical ≥99.0%) |
| 7 | Related Substances (HPLC) | Each ≤0.15%, total ≤0.50% or per customer-approved spec |
| 8 | Residual Solvents (GC) | In compliance with ICH Q3C |
| 9 | Water (KF) | ≤0.5–1.0% (depending on processing and packaging) |
| 10 | Melting Range | Provided on request (typical literature range: 209–216°C) |
| 11 | Retest Period | 1 year under recommended storage conditions (subject to stability data) |
| 12 | HS Code | Available upon request |
| 13 | Analytical Documentation | Complete IR, ¹H/¹³C NMR, MS, method summaries, impurity rationale, and stability data available under CDA/NDA |
| Specification | Details |
|---|---|
| Chemical Name | Glibenclamide Sulfonamide |
| Synonyms | As used in client-specific synthetic routes |
| CAS Number | 16673-34 |
| Molecular Formula & Weight | Provided on request with CDA/NDA |
| Appearance | Off-white to light beige crystalline powder |
| Assay (HPLC) | NLT 98.0% (typical ≥99.0%) |
| Related Substances (HPLC) | Each ≤0.15%, total ≤0.50% or per customer-approved spec |
| Residual Solvents (GC) | In compliance with ICH Q3C |
| Water (KF) | ≤0.5–1.0% depending on processing and packaging |
| Melting Range | Provided on request |
| Retest Period | Up to 24 months under original sealed conditions (subject to stability data) |
| HS Code | Available upon request |
| Analytical Documentation | Complete IR, ¹H/¹³C NMR, MS, method summaries, impurity rationale, and stability data available under CDA/NDA |
Key Safety Information
- Use appropriate personal protective equipment (PPE) during handling
- Avoid inhalation of dust or direct skin/eye contact
- Handle in well-ventilated and controlled manufacturing environments
- Follow GMP-compliant material handling procedures
- Refer to Safety Data Sheet (SDS) for detailed handling and emergency guidance
Safety Precaution
- Handle only within certified pharmaceutical manufacturing facilities
- Ensure use of appropriate personal protective equipment (PPE) at all times
- Prevent direct exposure through inhalation, skin contact, or eye contact
- Maintain proper containment and follow established GMP protocols
- Dispose of material strictly in accordance with applicable regulatory and environmental guidelines
Frequently Asked Questions (FAQs)
What is Glibenclamide Sulfonamide used for?
It’s the key intermediate used to manufacture Glibenclamide (Glyburide), a widely prescribed oral drug for type 2 diabetes. Any company producing Glibenclamide API needs this compound as a starting material earlier in the synthesis route.
What is the CAS number of Glibenclamide Sulfonamide?
CAS 16673-34. Use this number when comparing quotes across suppliers, it’s the fastest way to confirm you’re evaluating the exact same compound and not a related sulfonamide.
What purity does PYG Lifesciences supply, and how is it verified?
Assay NLT 98.0% by HPLC, typically ≥99.0%, with related substances controlled to ≤0.15% each and ≤0.50% total. Every batch is tested in-house before dispatch, and the COA you receive reflects the actual batch you’re buying not a generic spec sheet.
How long does it take to receive an order, and can I get a sample first?
Trial packs of 50 g–5 kg are available for R&D evaluation before you commit to bulk, so you can validate the material in your own process first. Standard commercial orders (25–50 kg MOQ) typically ship within 2–4 weeks of confirmed purchase order, depending on quantity and current production schedule.
Will the quality stay consistent if I place repeat orders?
Yes, batch-to-batch consistency is maintained through validated manufacturing processes and in-house QC on every lot (HPLC, GC, KF). If you’re switching from another supplier, PYG can run a side-by-side COA comparison against your current material to confirm equivalence before you commit.
Can PYG support my regulatory filing (DMF/CEP) for this intermediate?
Yes. Beyond the standard COA and SDS, full analytical documentation IR, ¹H/¹³C NMR, MS, and stability data is available under CDA/NDA to support DMF or CEP submissions.
Does PYG Lifesciences only sell standard intermediates, or can they manufacture to my own process?
Both. PYG Lifesciences supplies standard-grade Glibenclamide Sulfonamide directly, and also operates as a CMO meaning they can manufacture your own validated process at commercial scale under cGMP conditions. This is useful if you need dedicated capacity, scale-up support, or an alternate manufacturing source for your existing supply chain.
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