Dexmedetomidine Hcl API Manufacturer India

High-Quality Active Pharmaceutical Ingredient for Sedative / Alpha-2 Agonist Formulations

Swapnroop Pharma  ·  WHO-GMP Certified  ·  +91 87670 62101
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Dexmedetomidine Hcl API Manufacturer India

Product Specifications

Product Name: Dexmedetomidine Hcl API
CAS Number: 145108-58-3
Category: Active Pharmaceutical Ingredient
Grade: IP / BP / EP / USP
Appearance: White to off-white crystalline powder
Standards: IP / BP / EP / USP compliant

Detailed Specifications

ParameterSpecification
AppearanceWhite to off-white crystalline powder
IdentificationIR & HPLC compliant
Assay (HPLC)98.0% – 102.0%
Loss on DryingNMT 1.0%
Residue on IgnitionNMT 0.2%
Heavy MetalsNMT 10 ppm
pH (1% Solution)2.0 – 4.0
Individual Impurity≤ 0.5%
Total Impurities≤ 1.5%

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WHO-GMP certified · CoA + MSDS included · Ships to 40+ countries

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Dexmedetomidine Hcl API (CAS No: 145108-58-3)

High-Quality Active Pharmaceutical Ingredient for Icu Sedation And Procedural Sedation Formulations

Dexmedetomidine Hcl API is positioned for companies seeking a dependable active pharmaceutical ingredient source backed by organized quality systems and scalable supply support.

Our manufacturing and supply approach for Dexmedetomidine Hcl emphasizes dependable commercial support, efficient order management, and pharma-focused service for long-term buyers.

Dexmedetomidine Hcl is commonly assessed on quality consistency, handling profile, packaging suitability, and documentation readiness before it is approved for downstream formulation use.

Key Features

  • Documentation support aligned with customer qualification needs
  • Batch-to-batch consistency focused for commercial supply
  • Bulk packaging options designed for safe storage and dispatch
  • Supply planning suited to domestic and export demand

Applications

  • Suitable for formulation development and scale-up studies
  • Used by pharmaceutical buyers seeking consistent raw material supply and documentation coordination
  • Can support commercial procurement, validation batches, and routine production programs
  • Supports manufacturers working on ICU sedation, procedural sedation/analgesia, and dexmedetomidine infusion dosage forms dosage forms.

Why Choose Us

  • Consistent commercial communication and responsive quotation support
  • Focus on repeatability, supply continuity, and practical business support
  • Bulk packaging and logistics support for domestic and export dispatch
  • Structured documentation assistance for buyer evaluation

Packaging & Supply

We offer Dexmedetomidine Hcl API in pharma-oriented packaging formats including HDPE or fiber drum options with inner protection layers, helping maintain handling quality during storage, shipping, and routine supply movement.

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Frequently Asked Questions about Dexmedetomidine Hcl API

What is the CAS number for Dexmedetomidine Hcl API?

The CAS number for Dexmedetomidine Hcl API is 145108-58-3. It is an Active Pharmaceutical Ingredient (API) manufactured by Swapnroop Drugs and Pharmaceuticals, a WHO-GMP certified company in Maharashtra, India.

What pharmacopeial grades is Dexmedetomidine Hcl API available in?

Dexmedetomidine Hcl API is available in IP, BP, EP, and USP pharmacopeial grades with HPLC purity ≥98.0–102.0%. All batches come with full CoA, MSDS, and pharmacopeial identification testing.

What is the MOQ and lead time for Dexmedetomidine Hcl API?

Minimum order is 1 kg for sampling and 25 kg for commercial bulk supply. Standard lead time is 2–4 weeks from our Aurangabad, Maharashtra facility. Expedited supply is available for larger volumes.

Is DMF documentation available for Dexmedetomidine Hcl API?

Yes, Swapnroop provides full DMF-grade documentation for Dexmedetomidine Hcl API including CoA, MSDS, Genotoxic Impurity Report, Stability Data, and regulatory dossier support for USFDA, EMA, and CDSCO market submissions.

Does Swapnroop export Dexmedetomidine Hcl API internationally?

Yes, Swapnroop exports Dexmedetomidine Hcl API to 40+ countries including the USA, UK, UAE, Germany, Australia, South Africa, Nigeria, Kenya, Brazil, and Southeast Asian markets. We provide full export documentation and regulatory support.

Dexmedetomidine Hcl API Bulk Supplier in India

For companies evaluating Dexmedetomidine Hcl API manufacturer options in India, this page offers a clear overview of the product profile, quality approach, and supply readiness.

Dexmedetomidine Hcl API Manufacturer for Commercial Sourcing

Our team works with buyers who need Dexmedetomidine Hcl API backed by practical documentation support, organized batch handling, and efficient supply communication for ongoing business.