Sulfachlorpyridazine API Manufacturer in India

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Sulfachlorpyridazine API Manufacturer in India

Sulfachlorpyridazine API is a synthetic sulfonamide antibacterial active pharmaceutical ingredient used primarily in veterinary pharmaceutical applications. It belongs to the sulfonamide class of antibacterial compounds and is chemically identified as N¹-(6-Chloro-3-pyridazinyl)sulfanilamide or 4-amino-N-(6-chloropyridazin-3-yl)benzenesulfonamide. Sulfachlorpyridazine has the molecular formula C₁₀H₉ClN₄O₂S, molecular weight 284.72 g/mol, and CAS Number 80-32-0.

Sulfachlorpyridazine is listed by USP and is recognized by FDA substance records. The USP monograph identifies the substance as containing 97.0% to 103.0% of C₁₀H₉ClN₄O₂S, calculated on the dried basis. USP also specifies that the material is labeled for veterinary use only.

Chemical and Pharmaceutical Profile

Sulfachlorpyridazine is a synthetic sulfonamide compound containing a chloropyridazine ring linked to a sulfanilamide moiety. FDA's substance database identifies it as an achiral active moiety with molecular formula C₁₀H₉ClN₄O₂S and molecular weight 284.72 g/mol.

The compound is generally described as a white to faint-yellow crystalline powder. A USP reference-standard safety data sheet reports a melting range of approximately 187–193°C, while commercial analytical specifications commonly report values around 186–190°C.

Sulfachlorpyridazine has low water solubility. Published physicochemical data indicate substantially greater solubility in organic solvents than in water, while the USP reference-standard SDS describes it as practically insoluble in water.

Pharmaceutical and Veterinary Applications

Sulfachlorpyridazine is primarily associated with veterinary pharmaceutical formulations. FDA records identify Sulfachlorpyridazine in the context of approved animal-drug applications and veterinary antimicrobial use.

Sulfachlorpyridazine is used as a sulfonamide antibacterial active ingredient in veterinary medicine and has been incorporated into formulations intended for susceptible bacterial infections in animals. As with other antimicrobial APIs, its use is subject to applicable veterinary regulations, approved indications, species restrictions and residue requirements.

Mechanism of Action

Sulfachlorpyridazine belongs to the sulfonamide class of antibacterial agents. Sulfonamides act primarily by interfering with bacterial folate biosynthesis, particularly through inhibition of dihydropteroate synthase, an enzyme involved in the conversion of para-aminobenzoic acid into folate intermediates. This interferes with bacterial nucleic-acid synthesis and bacterial growth. KEGG identifies sulfachlorpyridazine as an antibacterial and dihydropteroate synthase inhibitor.

Quality and Analytical Testing

Sulfachlorpyridazine is covered by a USP monograph with defined requirements for identity, clarity and color of solution, acidity, loss on drying, residue on ignition and assay. The current USP-based procedure identifies the API using infrared spectroscopy and chromatographic retention time.

The USP assay uses liquid chromatography with a 265-nm detector, an L1 stationary phase and a pH 2.5 phosphate-buffer/methanol mobile phase. The compendial assay requirement is 97.0–103.0% on the dried basis.

USP specifies NMT 0.5% loss on drying after drying at 105°C for 3 hours and NMT 0.1% residue on ignition. The monograph also contains a specific acidity procedure rather than a conventional pH specification.

Sulfachlorpyridazine API Manufacturer in India

Swapnroop Drugs and Pharmaceuticals provides pharmaceutical API manufacturing and quality-support capabilities for Sulfachlorpyridazine, with analytical evaluation aligned with applicable pharmaceutical and customer-specific requirements.

Sulfachlorpyridazine API can be evaluated for identity, assay, loss on drying, residue on ignition and other applicable quality parameters according to the agreed specification and relevant pharmacopoeial requirements.

Packaging and Storage

Sulfachlorpyridazine should be maintained in well-closed, light-resistant containers in accordance with the USP monograph.

For commercial API handling, suitable moisture- and light-protective packaging should be selected according to the applicable product specification, transportation conditions and stability requirements.

Documentation

Depending on the customer's regulatory and commercial requirements, documentation may include:

  • Certificate of Analysis (CoA)
  • Product Specification
  • Certificate of Conformance
  • Safety Data Sheet (SDS)
  • Batch analytical data
  • HPLC analytical data
  • Identification/IR data
  • Loss on Drying results
  • Residue on Ignition results
  • Stability documentation, where applicable
  • Regulatory documentation, where applicable

Why Choose Sulfachlorpyridazine from Swapnroop?

Sulfachlorpyridazine is an established sulfonamide antibacterial API with a USP monograph defining identity, assay and key physicochemical quality requirements. Swapnroop focuses on controlled pharmaceutical API manufacturing, analytical quality evaluation and documentation support for veterinary pharmaceutical and API requirements.

For customers seeking Sulfachlorpyridazine API from India, product specifications, analytical documentation and commercial requirements can be evaluated according to the intended application and applicable regulatory standards.

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 97.0–103.0%
Loss on Drying NMT 0.5%
Residue on Ignition NMT 0.1%
Melting Point Approximately 187–193°C
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