Abaloparatide API Manufacturer in Maharashtra, India

Synthetic PTH Analogue for Osteoporosis – Anabolic Bone Formation Stimulator

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

Product Specifications

Product Name: Abaloparatide API
CAS Number: 247062-33-5
Category: Active Pharmaceutical Ingredient
Grade: Abaloparatide 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%

Abaloparatide API (CAS No: 247062-33-5)

PTH-Related Peptide Analogue for Osteoporosis Treatment and Bone Density Restoration

Abaloparatide (CAS 247062-33-5) is a synthetic 34-amino acid peptide analogue of parathyroid hormone-related protein (PTHrP) that selectively activates the PTH1 receptor to stimulate bone formation. Unlike teriparatide, abaloparatide exhibits a conformational bias toward the RG conformation of PTH1R, resulting in more anabolic bone-building activity with reduced hypercalcemia risk, making it a next-generation treatment for postmenopausal osteoporosis.

Peptide API sourcing requires stringent control of acetylation, deamidation, and oxidation-related impurities identified by RP-HPLC with UV detection at 220 nm. Abaloparatide's 34-residue sequence demands validated solid-phase peptide synthesis (SPPS) with Fmoc chemistry and rigorous purification to achieve ≥98% purity with less than 0.5% total impurities. Counter-ion (acetate) content and water content by KF must meet pharmacopeial specification.

Swapnroop supplies Abaloparatide API with high-purity peptide synthesis and analytical characterisation from our WHO-GMP facility in Aurangabad. Our documentation package includes HPLC purity profile, amino acid analysis (AAA), mass spectrometry (ESI-MS) molecular weight confirmation, and counter-ion content — the complete analytical suite required for subcutaneous injection formulation development and regulatory filing.

Key Features

  • Peptide purity ≥98% by RP-HPLC with individual impurity ≤0.5%
  • Amino acid analysis (AAA) confirming correct sequence composition
  • ESI-MS molecular weight confirmation (MW: 3960.7 Da)
  • Acetate counter-ion content and water content (KF) per pharmacopeial specification

Applications

  • Subcutaneous injection formulation (80 mcg/dose) for osteoporosis treatment
  • Postmenopausal osteoporosis clinical trial API sourcing
  • Bone mineral density restoration in high-fracture-risk patient populations
  • Comparative bioavailability and biosimilar development research

Why Choose Swapnroop for Abaloparatide?

  • Peptide-specialised WHO-GMP manufacturing with Fmoc SPPS methodology
  • Full analytical suite: HPLC, AAA, ESI-MS, CD spectroscopy on request
  • Cold chain logistics (−20°C) for peptide API international shipment
  • Regulatory filing support for innovative peptide drug NDA programs

Packaging & Supply

Abaloparatide peptide API is supplied in lyophilised powder form in sterile glass vials (10 mg, 50 mg, 100 mg) or bulk in foil-lined HDPE bottles under nitrogen blanket. Cold chain shipping (2–8°C or −20°C as per stability protocol) is mandatory for international peptide API export.

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Frequently Asked Questions about Abaloparatide API

What is the CAS number for Abaloparatide API?

The CAS number for Abaloparatide is 247062-33-5. It is a synthetic 34-amino acid PTHrP analogue peptide used for osteoporosis treatment.

What is the mechanism of action of Abaloparatide?

Abaloparatide is an anabolic bone agent that activates PTH1R receptors, stimulating osteoblast-mediated new bone formation. Unlike antiresorptive agents, it directly builds new bone tissue, increasing BMD at the lumbar spine and hip.

What purity specifications are available for Abaloparatide?

Abaloparatide API is supplied at ≥97% purity by RP-HPLC with additional peptide mapping, amino acid composition, mass spectrometry confirmation, and impurity profiling (truncated sequences, oxidation products).

What are the storage requirements for Abaloparatide API?

Abaloparatide peptide API must be stored at 2–8°C in sealed containers under inert atmosphere. Avoid freeze-thaw cycles. Shelf life is typically 18–24 months under recommended conditions.

Can Swapnroop supply Abaloparatide for clinical trial programs?

Yes, we supply Abaloparatide API for Phase II/III clinical trials and NDA submissions with complete analytical documentation, batch records, and regulatory filing support.

Abaloparatide API Bulk Supplier in Aurangabad, Maharashtra, India

Swapnroop Drugs and Pharmaceuticals is a trusted Abaloparatide 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 Abaloparatide API supply with full pharmacopeial compliance, competitive pricing, and complete regulatory documentation for domestic and export programs.

Abaloparatide API Exporter from India – Regulatory Filing Support

As a Abaloparatide 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 Abaloparatide API pricing, samples, and sourcing support.