Sulfamonomethoxine API Manufacturer in India

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Sulfamonomethoxine API Manufacturer in India

Sulfamonomethoxine API

Sulfamonomethoxine is a long-acting sulfonamide antibacterial active pharmaceutical ingredient (API). It belongs to the sulfonamide class of antimicrobial compounds and is chemically identified as 4-amino-N-(6-methoxypyrimidin-4-yl)benzenesulfonamide.

Sulfamonomethoxine has CAS Number 1220-83-3, molecular formula C₁₁H₁₂N₄O₃S and molecular weight 280.31 g/mol. It is recognized as a long-acting sulfonamide antibacterial agent and has applications particularly associated with veterinary pharmaceutical preparations.

Chemical and Pharmaceutical Profile

Sulfamonomethoxine contains a sulfanilamide structure linked to a methoxypyrimidine ring. The API is generally characterized as a white to pale-yellow crystalline material.

The compound has four nitrogen atoms and a sulfonamide functional group that contributes to its antibacterial activity. Analytical identification may be performed using infrared spectroscopy together with appropriate chromatographic or chemical testing.

Sulfamonomethoxine has a molecular weight of 280.31 g/mol and is practically insoluble in water in its pharmacopoeial hydrate form. It is soluble in acetone and slightly soluble in ethanol.

Pharmaceutical Applications

Sulfamonomethoxine is a long-acting sulfonamide antibacterial API used primarily in veterinary pharmaceutical applications.

Its antibacterial activity is associated with inhibition of bacterial folate biosynthesis. Sulfonamides act as structural analogues of para-aminobenzoic acid (PABA) and interfere with dihydropteroate synthase, an enzyme involved in the formation of folate intermediates required for bacterial growth.

Sulfamonomethoxine has been investigated and used in veterinary medicine for susceptible bacterial infections in various animal species, subject to applicable veterinary regulations and approved product indications.

Quality and Analytical Testing

Sulfamonomethoxine API can be evaluated through a combination of identity, assay, moisture and physical-property testing.

The Japanese Pharmacopoeia monograph for Sulfamonomethoxine Hydrate specifies that the dried material contains not less than 99.0% Sulfamonomethoxine. It also specifies loss on drying of not more than 0.5% and residue on ignition of not more than 0.1%.

Typical analytical controls may include:

  • Infrared identification
  • Pharmacopoeial assay
  • HPLC purity testing where included in the applicable specification
  • Loss on drying
  • Residue on ignition
  • Related-substance testing
  • Physical appearance
  • Melting-point determination
  • Solubility evaluation

The applicable analytical method should always correspond to the agreed product specification and regulatory standard.

Sulfamonomethoxine API Manufacturer in India

Swapnroop Drugs and Pharmaceuticals provides pharmaceutical API manufacturing capabilities for Sulfamonomethoxine with quality-focused analytical controls and documentation.

Sulfamonomethoxine API can be handled according to applicable pharmacopoeial requirements and agreed customer specifications. Quality evaluation can cover identity, assay, moisture, inorganic residue, impurities and physical characteristics according to the applicable specification.

For pharmaceutical and veterinary pharmaceutical companies requiring Sulfamonomethoxine API from an India-based manufacturer, specification alignment, batch consistency, analytical testing and appropriate documentation are important considerations.

Packaging and Storage

Sulfamonomethoxine API should be stored in suitable, tightly closed pharmaceutical packaging that protects the material from moisture, contamination and excessive environmental exposure.

The Japanese Pharmacopoeia specifies well-closed containers and light-resistant storage for Sulfamonomethoxine Hydrate.

Recommended handling includes:

  • Store in a cool and dry environment.
  • Protect from excessive light.
  • Protect from moisture.
  • Keep containers tightly closed.
  • Use suitable pharmaceutical-grade packaging.
  • Follow the storage conditions specified in the applicable product specification.

Documentation

Depending on customer and regulatory requirements, documentation may include:

  • Certificate of Analysis (CoA)
  • Product specification
  • Safety Data Sheet (SDS)
  • Batch analytical data
  • Technical documentation
  • Packaging information
  • Stability documentation where applicable
  • Regulatory documentation as agreed with the customer

Why Choose Sulfamonomethoxine API from Swapnroop?

Swapnroop Drugs and Pharmaceuticals focuses on pharmaceutical API manufacturing with quality systems, analytical evaluation and documentation intended to support pharmaceutical applications.

Sulfamonomethoxine API is handled according to defined quality requirements, with attention to identity, assay, impurities, physical characteristics and batch-to-batch consistency.

Customers can discuss Sulfamonomethoxine API requirements, applicable specifications, packaging and documentation with Swapnroop Drugs and Pharmaceuticals.

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 0.5%
Residue on Ignition NMT 0.1%
Melting Point 203–206°C
Solubility Practically insoluble in water; soluble in acetone; slightly soluble in ethanol; very slightly soluble in diethyl ether
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