Suramin API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Suramin API – Product Overview

Suramin is a synthetic polysulfonated naphthylurea compound and an established antiparasitic active pharmaceutical ingredient. The pharmaceutical substance is generally used in the form of Suramin Sodium (hexasodium salt). FDA GSRS identifies Suramin Sodium with CAS No. 129-46-4, molecular formula C₅₁H₃₄N₆Na₆O₂₃S₆, and molecular weight 1,429.18 g/mol.

Suramin Sodium is used primarily as an antitrypanosomal and antifilarial medicine, particularly in the treatment of certain forms of African trypanosomiasis and onchocerciasis. WHO sources identify Suramin Sodium as a parenteral medicine supplied as a powder for injection.

Suramin is chemically different from conventional small-molecule antibacterial sulfonamides. Its six sulfonate groups give the molecule a highly polar, polyanionic character.

API Overview

The parent compound Suramin has CAS No. 145-63-1, while the pharmaceutical sodium salt is Suramin Sodium, CAS No. 129-46-4. FDA GSRS specifically identifies Suramin Sodium as the hexasodium salt of Suramin.

Suramin Sodium is also known by synonyms including Suramin Hexasodium, Suramin Sodium, Antrypol, Moranyl, Naganin, Naphuride Sodium and Fourneau 309.

Chemical and Pharmaceutical Profile

Suramin Sodium is a highly sulfonated aromatic compound containing six sodium ions associated with six sulfonate groups. FDA GSRS classifies it as achiral, with no defined stereocenters or E/Z centers.

The parent Suramin has molecular formula C₅₁H₄₀N₆O₂₃S₆ and molecular weight approximately 1297.3 g/mol, while Suramin Sodium has molecular formula C₅₁H₃₄N₆Na₆O₂₃S₆ and molecular weight approximately 1429.18 g/mol.

Pharmaceutical Applications

Suramin Sodium is primarily used as an antitrypanosomal and antifilarial API.

Its established pharmaceutical applications include:

  • Treatment of first-stage African trypanosomiasis
  • Treatment of susceptible Trypanosoma infections
  • Treatment of onchocerciasis
  • Antifilarial pharmaceutical applications
  • Development of parenteral antiparasitic formulations

WHO references identify Suramin Sodium as a medicine for African trypanosomiasis and filariasis, with a parenteral formulation of 1 g in a vial listed in WHO medicine information.

Mechanism of Action

Suramin has a complex pharmacological mechanism involving interaction with extracellular and cellular targets. It is a highly negatively charged molecule that can interfere with the activity or binding of several proteins and growth factors.

Suramin Sodium has been reported to interfere with growth-factor signaling, including interactions involving IGF-I, EGF, PDGF, TGF-β, VEGF and bFGF. It also has documented effects on several enzymatic and receptor-associated pathways.

Its clinically established antiparasitic activity is associated with interference with essential biochemical processes in susceptible trypanosomes and filarial parasites.

Quality and Analytical Testing

Suramin Sodium is a complex, high-molecular-weight pharmaceutical substance. The exact analytical specification should be established for the Suramin Sodium hexasodium form, rather than applying specifications from the parent Suramin compound.

FDA GSRS confirms the pharmaceutical identity as Suramin Sodium, CAS 129-46-4, molecular formula C₅₁H₃₄N₆Na₆O₂₃S₆, and molecular weight 1,429.18.

No current universal numerical USP/BP/Ph. Eur. release specification for every CMS parameter was verified from the authoritative sources reviewed. Therefore, unsupported assay, impurity, water or ash limits should not be inserted.

Manufacturing

Suramin Sodium API manufacturing requires controlled chemical synthesis, sulfonation, purification and conversion to the sodium salt, followed by appropriate isolation and drying.

Manufacturing controls should address:

  • Chemical identity
  • Assay/potency
  • Related substances
  • Sulfonated structural profile
  • Sodium content where applicable
  • Water/moisture
  • Residual solvents
  • Elemental impurities
  • Microbiological quality where applicable
  • Physical characteristics
  • Batch consistency

Validated chromatographic, spectroscopic and other suitable analytical procedures can be used for quality control and stability testing.

Physical and Physicochemical Properties

Suramin Sodium is a high-molecular-weight, highly water-compatible polyanionic compound. Historical WHO material describes Suramin as a white, finely crystalline powder and notes that it is slowly but freely soluble in water.

FDA GSRS identifies Suramin Sodium as achiral, with no optical activity and no defined stereocenters.

Packaging and Storage

Suramin Sodium should be stored in suitable pharmaceutical-grade, tightly closed packaging that protects the API from moisture, contamination and environmental exposure.

Storage conditions should ultimately be established using validated stability data for the manufactured API.

For injectable pharmaceutical applications, packaging should be compatible with the applicable sterile/parenteral manufacturing and formulation requirements.

Documentation

Typical Suramin Sodium API documentation may include:

  • Certificate of Analysis (CoA)
  • Product Specification
  • Safety Data Sheet (SDS)
  • Analytical method information
  • Batch documentation
  • Related-substance/impurity profile
  • Residual-solvent information
  • Water-content data
  • Stability information
  • Regulatory documentation
  • Technical Data Sheet

Why Choose Suramin API Manufacturer in India

A qualified Suramin API manufacturer should maintain controlled manufacturing, validated analytical procedures and complete batch traceability.

Particular attention should be given to identity, assay, impurity profile, moisture, sodium content, residual solvents and physical properties to ensure consistent pharmaceutical-grade material.

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
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