Dulaglutide 99% CAS No: 923950-08-7
Dulaglutide 99% CAS No: 923950-08-7
Dulaglutide,Dulaglutide 99% ,CAS No: 923950-08-7,C149H221N37O49
Product Name: Dulaglutide
Product purity: ≥ 99%
CAS No: 923950-08-7
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Description
Long-Acting GLP-1 Fusion ProteinDulaglutide API & Research Grade Supply
Premium Biological Active Ingredient for Once-Weekly Peptide Preparation Research and Advanced Generic Scaling Up
Purity ≥ 99.0% (SEC-HPLC)
Host Cell Protein ≤ 100 ppm
Host Cell DNA ≤ 10 ng/mg
CAS 923950-08-7
⚠ REGULATORY COMPLIANCE DIRECTIVE: INDUSTRIAL B2B SUPPLY ONLY
Shaanxi Sunrise Pharmaceutical Co., Ltd. operates strictly as an industrial active raw material and ingredient manufacturer and supplier. This product is a high-purity biological substance synthesized through recombinant DNA technology, intended exclusively for laboratory scientific research, non-clinical assay calibration, and generic drug formulation development. Shaanxi Sunrise strictly prohibits the distribution or retail of raw materials to private individuals for direct human consumption or clinical therapies.
Product Overview
In the sector of modern metabolic drug design and advanced biosimilar evaluation, maintaining supreme structural consistency is paramount. Dulaglutide (CAS 923950-08-7) supplied by Shaanxi Sunrise Pharmaceutical Co., Ltd. is a highly potent recombinant GLP-1 receptor agonist. Unlike standard linear peptides, Dulaglutide is a specialized macromolecular fusion protein consisting of two identical disulfide-linked chains, each containing a human GLP-1 analogue sequence covalently linked to a modified human immunoglobulin G4 (IgG4) Fc fragment via a small peptide linker.
Our premium biological-grade Dulaglutide API is synthesized through optimized mammalian cell expression technology and purified via precise orthogonal chromatography steps. This industrial rigour successfully reduces host cell protein (HCP) and host cell DNA (HCD) impurities well below international regulatory thresholds. It provides an exceptionally stable, highly bio-active reference standard for generic formulators and contract manufacturing organizations (CMOs) optimizing long-acting, once-weekly injectable formulations.
Dual-Target Activation & Extended Half-Life Kinetics
As an advanced long-acting GLP-1 receptor agonist, Dulaglutide mimics physiological incretin hormones with superior enzymatic resistance. The therapeutic execution follows a multi-organ cascade:
Glucose-Dependent Insulin Control: It specifically binds to and activates pancreatic GLP-1 receptors, upregulating cyclic AMP (cAMP) to trigger glucose-dependent insulin secretion from pancreatic β-cells.
Glucagon Secretion Suppression: It effectively suppresses excessive postprandial glucagon release from alpha cells, reducing inappropriate hepatic glucose output.
Gastric Emptying Regulation: It modulates gastric motility, inducing a controlled delay in gastric emptying to flatten post-meal glucose spikes.
IgG4 Fc Fusion Defense: The large molecular framework (approx. 59.7 kDa) completely blocks renal glomerular filtration while the modified sequence resists dipeptidyl peptidase-4 (DPP-4) degradation, expanding the metabolic half-life to enable a once-weekly dosing profile.
Applications & Pharmacological Scope
Weekly Preparation Development
Ideally qualified as an active control raw standard for researching extended-release parenteral formulations, analyzing viscosity, and verifying syringe compatibility metrics.
Type 2 Diabetes Research
Serving as a highly stable reference agonist for benchmarking glucose control profiles, tracing beta-cell protection pathways, and analyzing insulin sensitivity shifts.
Weight Management Studies
Investigating central neurological mechanisms involved in satiety regulation, mapping feeding behavior modifications, and analyzing lipolysis pathways in non-clinical metabolic assays.
Audited Release Specifications & Quality Parameters
| Analytical Specification Parameter | Regulatory Monograph Limit | Actual Batch Release Result | Validated Methodology |
|---|---|---|---|
| Purity (Monomer Percent) | ≥ 98.0% | ≥ 99.42% | Size Exclusion HPLC (SEC-HPLC) |
| Host Cell Protein (HCP) | ≤ 100 ppm | ≤ 32 ppm | Enzyme-Linked Immunosorbent Assay |
| Host Cell DNA (HCD) | ≤ 10 ng/mg | ≤ 2.5 ng/mg | Quantitative PCR (qPCR) |
| Bacterial Endotoxins | ≤ 5.0 EU/mg | ≤ 1.2 EU/mg | LAL Gel Clot Method |
| Cell-Based Bioactivity (cAMP) | 90.0% – 130.0% vs RLD | 106.8% | In Vitro Reporter Gene Assay |
| Moisture Content | ≤ 5.0% | 2.4% | Karl Fischer Titration |
Technical Support & Frequently Asked Questions
What makes Dulaglutide structurally different from standard Liraglutide API?
Dulaglutide is a large recombinant fusion protein with an approximate molecular mass of 59.7 kDa, whereas Liraglutide is a smaller synthetic peptide (approx. 3.7 kDa) acylated with a C16 fatty acid chain. The massive molecular footprint of Dulaglutide fundamentally protects it from renal clearance, extending its half-life to support a once-weekly dosing profile rather than a once-daily regimen.
How is the biological potency and receptor affinity of your Dulaglutide verified?
Every commercial batch undergoes strict quality release mapping. Purity is validated via reversed-phase and size-exclusion high-performance liquid chromatography. More importantly, biological activity is quantified using an in vitro cell-based reporter gene assay that measures GLP-1 receptor-mediated cAMP production against the reference listed drug (RLD), ensuring full functional conformance.
What documentation is provided to support international regulatory dossiers?
Shaanxi Sunrise Pharmaceutical attaches a comprehensive technical audit package to every shipment. This contains a detailed Certificate of Analysis (COA) specifying SEC-HPLC profiles, HCP/HCD trace clearance data, an exhaustive Material Safety Data Sheet (MSDS), and a Technical Data Sheet (TDS) for complete corporate transparency.