Abacavir Hydrochloride API Manufacturer in Maharashtra, India

HCl Salt Form of Abacavir NRTI – Enhanced Solubility for HIV Formulations

Abacavir Hydrochloride API Manufacturer and Bulk Supplier in Maharashtra, India – Swapnroop Pharma

Product Specifications

Product Name: Abacavir Hydrochloride API
CAS Number: 136470-78-5
Category: Active Pharmaceutical Ingredient
Grade: Abacavir Hydrochloride 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%

Abacavir Hydrochloride API (CAS No: 136470-78-5)

Hydrochloride Salt Form of Abacavir NRTI for Specialised Antiretroviral Formulations

Abacavir Hydrochloride (CAS 136470-78-5 as HCl salt) is the hydrochloride salt form of the carbocyclic nucleoside reverse transcriptase inhibitor Abacavir, used in select antiretroviral formulations where salt form selection affects dissolution profile, stability, and hygroscopicity compared to the free base. This form is evaluated in early-stage formulation development and for specific regulatory market requirements.

The hydrochloride salt of Abacavir exhibits distinct solid-state characteristics including different crystal morphology, solubility behaviour, and stability profile compared to Abacavir sulfate or free base. Formulators sourcing this form require rigorous polymorphic characterisation (XRPD, DSC) and particle size distribution data to ensure tablet uniformity and bioavailability equivalence.

Swapnroop supplies Abacavir Hydrochloride API with full pharmacopeial characterisation from our Aurangabad WHO-GMP facility. Our technical team provides salt-form-specific analytical data including XRPD patterns, DSC thermograms, and comparative dissolution profiles to support IND and ANDA filing requirements.

Key Features

  • Hydrochloride salt characterisation with XRPD and DSC data provided
  • Specific rotation and optical purity testing per pharmacopeial requirements
  • Controlled particle size distribution (D10/D50/D90) for tablet uniformity
  • Available in R&D quantities (100g) and commercial bulk (25 kg+)

Applications

  • Specialised antiretroviral formulation development studies
  • Salt form selection and comparative bioavailability research
  • IND-stage formulation studies requiring salt-specific characterisation
  • Fixed-dose combination development requiring specific dissolution profiles

Why Choose Swapnroop for Abacavir Hydrochloride?

  • Salt-form specific analytical package including XRPD, DSC, and solubility data
  • WHO-GMP certified facility with validated hydrochloride salt manufacturing process
  • Technical consultancy for salt form selection in ARV formulation development
  • Fast turnaround on sampling quantities for early-stage R&D programs

Packaging & Supply

Abacavir Hydrochloride API is packaged in amber glass bottles (100g, 500g) for R&D quantities and triple-layer HDPE drums for commercial volumes, with desiccant and nitrogen purging to maintain stability during storage and international shipment.

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Frequently Asked Questions about Abacavir Hydrochloride API

What is the CAS number for Abacavir Hydrochloride?

Abacavir Hydrochloride shares the base CAS number 136470-78-5 with Abacavir base. It is the HCl salt form with distinct physicochemical properties compared to the sulfate salt.

How does Abacavir Hydrochloride differ from Abacavir Sulfate?

The HCl and sulfate are different salt forms of Abacavir with varying aqueous solubility, hygroscopicity, and stability profiles. Selection depends on formulation compatibility, target pH environment, and regulatory precedent.

What polymorphic data is provided with Abacavir HCl API?

We provide XRPD diffractogram and DSC thermogram data confirming the consistent crystalline polymorphic form of Abacavir Hydrochloride with every commercial batch.

What is the minimum order quantity?

MOQ is 1 kg for sampling and 25 kg for commercial bulk orders. Custom pack sizes available for formulation development programs.

Is this product suitable for ANDA filings in the US?

Yes. Swapnroop provides DMF-grade documentation for Abacavir Hydrochloride API suitable for ANDA Type II DMF filings with USFDA, including full analytical data packages and regulatory correspondence support.

Abacavir Hydrochloride API Bulk Supplier in Aurangabad, Maharashtra, India

Swapnroop Drugs and Pharmaceuticals is a trusted Abacavir Hydrochloride API manufacturer and bulk supplier in Aurangabad, Maharashtra, serving pharmaceutical formulation companies across India and 25+ international markets. Our WHO-GMP certified facility provides consistent Abacavir Hydrochloride API supply with full pharmacopeial compliance, competitive pricing, and complete regulatory documentation for domestic and export programs.

Abacavir Hydrochloride API Exporter from India – Regulatory Filing Support

As a Abacavir Hydrochloride API exporter from Maharashtra, India, Swapnroop supports pharmaceutical companies worldwide with DMF-grade documentation, Certificate of Analysis, MSDS, impurity profiles, and regulatory filing assistance for USFDA, EMA, and CDSCO submissions. Contact us for Abacavir Hydrochloride API pricing, samples, and sourcing support.