Glibenclamide Sulfonamide Manufacturer in India
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
Glibenclamide Sulfonamide is a sulfonylurea-based pharmaceutical intermediate crucial to the synthesis of Glibenclamide (Glyburide), a widely prescribed oral antidiabetic agent for type 2 diabetes. As a prominent manufacturer and supplier in India, PYG Lifesciences offers pharma-grade Glibenclamide Sulfonamide with rigorous impurity control, dependable batch-to-batch consistency, and export-compliant documentation. Backed by deep expertise in sulfonamide and sulfonylurea chemistry, PYG delivers on-spec supply for both commercial production and R&D in regulated and semi-regulated markets.
Applications of Glibenclamide Sulfonamide
Pharmaceutical Intermediate
A key intermediate in the multi-step synthesis of Glibenclamide (Glyburide), a second-generation sulfonylurea oral antidiabetic drug. Its high assay and controlled impurity levels support consistent downstream reactions, final API quality and regulatory compliance.
Research & Process Development
Used in route scouting for Glibenclamide and related sulfonylurea derivatives, impurity fate and mapping studies, and crystallization optimization. Suitable for scale-up from kilo-lab quantities to pilot and commercial scale.
Custom Synthesis Programs (CRAMS/CDMO Integration)
Available as part of CRAMS or CDMO projects to develop related sulfonamide and sulfonylurea building blocks for antidiabetic NCE development, with support for impurity reduction, solvent substitution and yield enhancement.
Regulatory & Analytical Use
Suitable for reference standard generation, method development and validation for Glibenclamide API analysis, and stability studies. Supports data generation for DMF and CEP regulatory submissions.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
- Low acute toxicity
- Primarily a nuisance dust irritant for eyes, mucous membranes, and upper respiratory tract
This pharmaceutical intermediate is intended exclusively for industrial pharmaceutical manufacturing and research applications, particularly in the synthesis of sulfonylurea-class antidiabetic drugs (such as Glibenclamide). It is not intended for direct medicinal or human use.
Safety Precaution
- Minimize airborne dust formation and static accumulation during scooping or bulk transfer
- Follow standard cGMP powder handling protocols
- Wear standard safety glasses with side shields, disposable nitrile gloves, and an N95 dust mask for particulate protection
- Store in well-closed, moisture-resistant containers at controlled room temperature (15–25°C) in a dry, ventilated area away from direct sunlight
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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