Vidarabine API Manufacturer and Supplier in India

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

Vidarabine API Manufacturer and Supplier in India

Swapnroop Drugs & Pharmaceuticals is a manufacturer and supplier of Vidarabine API for pharmaceutical formulation, development, research and regulated pharmaceutical manufacturing applications.

Vidarabine, also known as Adenine Arabinoside, Ara-A and Arabinosyladenine, is a synthetic purine nucleoside analogue with antiviral activity. It interferes with viral DNA synthesis and has historically been used in pharmaceutical products for infections caused by herpes simplex virus and varicella-zoster virus.

Vidarabine is identified by CAS No. 5536-17-4, with molecular formula C₁₀H₁₃N₅O₄ and molecular weight approximately 267.24 g/mol.

Vidarabine API Overview

Vidarabine is a synthetic nucleoside analogue consisting of an adenine base linked to a β-D-arabinofuranose sugar. It is also known as 9-β-D-arabinofuranosyladenine.

The API is a crystalline pharmaceutical substance and has historically been used as an antiviral active ingredient. Its mechanism involves interference with viral DNA synthesis, particularly through inhibition of viral DNA polymerase and incorporation-related effects on viral nucleic-acid synthesis.

Vidarabine is distinct from vidarabine monohydrate in terms of molecular composition. The anhydrous substance has CAS 5536-17-4 and molecular weight approximately 267.24 g/mol, while the monohydrate has a molecular weight of approximately 285.26 g/mol.

Pharmaceutical Applications

Vidarabine API has antiviral applications associated primarily with herpesvirus infections.

Potential pharmaceutical applications include:

  • Antiviral pharmaceutical formulations
  • Herpes simplex virus research
  • Varicella-zoster virus research
  • Nucleoside analogue development
  • Antiviral drug development
  • Pharmaceutical formulation research
  • Pharmaceutical API development

Vidarabine has historically been used against herpes simplex virus and varicella-zoster virus infections.

Vidarabine API for Pharmaceutical Manufacturing

Vidarabine is a chemically defined small-molecule API with established historical USP monograph requirements. The USP monograph describes Vidarabine potency in terms of micrograms of anhydrous vidarabine per milligram of substance rather than simply using a conventional percentage assay.

The USP specification states a potency equivalent to not less than 845 µg and not more than 985 µg of anhydrous C₁₀H₁₃N₅O₄ per mg, corresponding to approximately 84.5–98.5% potency on that basis. It also specifies loss on drying of 5.0–7.0% under the stated vacuum-drying conditions.

For pharmaceutical API manufacturing, quality evaluation can include:

  • Identification
  • Assay/potency
  • Loss on drying
  • Specific rotation
  • Related substances
  • Water content
  • Residue on ignition
  • Heavy metals
  • Microbiological quality where applicable

Vidarabine API Manufacturer and Supplier

Swapnroop Drugs & Pharmaceuticals provides Vidarabine API manufacturing and supply support for pharmaceutical companies, formulation manufacturers and qualified customers.

As a Vidarabine API manufacturer and supplier in India, Swapnroop supports pharmaceutical requirements involving controlled specifications, analytical documentation and bulk API supply.

Vidarabine API can support:

  • Pharmaceutical formulation development
  • Antiviral drug development
  • Bulk API requirements
  • Pharmaceutical manufacturing
  • Analytical research
  • Product development
  • Regulatory-oriented pharmaceutical applications

Packaging and Storage

Vidarabine API should be stored in suitable tightly closed, light-resistant pharmaceutical-grade containers under controlled environmental conditions.

The material should be protected from excessive moisture, heat and unsuitable environmental exposure. Storage conditions should follow the applicable material specification and stability requirements.

Documentation

Typical pharmaceutical documentation may include:

  • Certificate of Analysis (CoA)
  • Product Specification
  • Batch Analytical Report
  • Safety Data Sheet (SDS)
  • Manufacturing Documentation
  • Analytical Documentation
  • Regulatory Documentation, where applicable
  • Stability Documentation, where applicable
  • Technical Documentation, where applicable

Quality Considerations

Vidarabine has historically been covered by a USP monograph with specific controls for potency, identification, specific rotation, loss on drying and applicable microbiological requirements.

The USP monograph specifies specific rotation between −56.0° and −65.0° at 365 nm using an anhydrous Vidarabine test solution in dimethylformamide. It also specifies loss on drying of 5.0–7.0% under vacuum at 100°C for four hours.

Published pharmaceutical API specifications may differ from the older USP monograph and can include tighter controls such as assay 99.0–101.0%, water NMT 1.0%, heavy metals NMT 10 ppm, residue on ignition NMT 0.1% and total impurities NMT 0.5%. These should be treated as manufacturer/API specifications rather than automatically representing the current universal pharmacopoeial limit.

Why Choose Swapnroop for Vidarabine API?

Swapnroop Drugs & Pharmaceuticals supports pharmaceutical manufacturers and qualified customers seeking Vidarabine API for formulation, development and pharmaceutical manufacturing applications.

Our approach focuses on:

  • Controlled API quality
  • Specification-based manufacturing
  • Analytical documentation
  • Batch-specific documentation
  • Bulk API supply
  • Pharmaceutical manufacturing support
  • Technical documentation
  • Professional customer support

Swapnroop supports customers looking for Vidarabine API Manufacturer and Supplier in India.

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 99.0–101.0% on anhydrous basis
Loss on Drying NMT 2.0%
Residue on Ignition NMT 0.10%
Heavy Metals NMT 10 ppm
Individual Impurity NMT 0.10%
Total Impurities NMT 0.50%
Water Content NMT 1.0%
Specific Rotation −56.0° to −65.0° at 365 nm
Melting Point 257–261°C (decomp.)
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