Description

Product Name: Insulin Degludec Side Chain API
Molecular Weight Range: N/A (Specific chemical compound)
Appearance: White to off-white crystalline powder
Functions:
1.Long-acting Insulin Analog Development: Critical intermediate for creating ultra-long-acting basal insulin formulations with extended duration of action
2.Multi-hexamer Formation: Enables stable subcutaneous depot creation through unique self-association properties
3.Improved Pharmacokinetic Profile: Facilitates development of insulin products with flatter, more predictable action curves
4.Hypoglycemia Risk Reduction: Supports creation of insulin therapies with significantly lower hypoglycemia incidence
5.Flexible Dosing Enablement: Allows development of insulin products with dosing time flexibility
6.Combination Therapy Foundation: Serves as building block for advanced insulin/GLP-1 receptor agonist combination products
Molecular Formula: C₁₆H₂₈O₄ (Hexadecanedioic acid derivative)
Molecular Weight: 284.39 g/mol

Our Product Superiority: Why Choose Us?

1. Uncompromising Purity and Quality Standards:
Our Insulin Degludec Side Chain is manufactured to exceed pharmacopeial standards, with HPLC purity consistently exceeding 98.5% and stringent control of related substances. Through advanced purification technologies including preparative HPLC and crystallization optimization, we ensure minimal impurity profiles that meet the most demanding requirements for pharmaceutical product development. Each batch is accompanied by comprehensive analytical documentation including COA, NMR, and MS data.

2. Global Regulatory Compliance and Certification:
We maintain the highest standards of manufacturing excellence with ISO 9001, ISO 22000, HACCP, HALAL, GMPC, and U.S. GRAS certifications. Our facility operates under pharmaceutical cGMP guidelines, ensuring complete documentation traceability and regulatory compliance. This comprehensive quality framework provides assurance to global pharmaceutical partners seeking reliable API intermediate suppliers for regulated markets.

3. Technical Expertise and Process Optimization:
Leveraging years of experience in peptide chemistry and pharmaceutical intermediates, we have developed proprietary synthetic routes that ensure superior yield, purity, and cost-effectiveness. Our technical team provides extensive support including process optimization, analytical method development, and regulatory documentation assistance throughout the product development lifecycle.

4. Supply Chain Reliability and Scalability:
We have established robust supply chains for key starting materials and implemented scalable manufacturing processes capable of supporting projects from clinical development through commercial supply. Our flexible manufacturing approach allows us to accommodate varying batch sizes and timelines, ensuring reliable supply for our partners’ development programs.

5. Customization and Technical Partnership:
We offer customization options including specific salt forms, particle size engineering, and packaging configurations to meet unique formulation requirements. Our collaborative approach ensures we become an extension of your development team, providing technical insights and problem-solving support to accelerate your insulin degludec development programs.

 

Packaging & Storage
1.Packaging: Our Insulin Degludec Side Chain is packaged in double-bagged, vacuum-sealed aluminum foil pouches within dedicated pharmaceutical-grade containers. Primary packaging includes 1g, 5g, 10g, and 100g quantities, with custom packaging configurations available for larger scale requirements. All packaging materials are qualified for compatibility and protection against moisture and oxygen ingress.
2.Storage: CRITICAL – Store at -20°C ± 5°C in a temperature-monitored environment. Protect from light and moisture. Maintain containers sealed under inert atmosphere until use. Under validated conditions, the product maintains stability for 24 months. Avoid repeated freeze-thaw cycles. For manufacturing use, allow the product to equilibrate to room temperature in sealed condition before opening.

 

Handling Instructions:
1.Maintain strict temperature control during storage and transportation
2.Equilibrate to room temperature in sealed condition before opening
3.Use under inert atmosphere when handling for extended periods
4.Store opened containers under nitrogen or argon atmosphere
5.Use appropriate personal protective equipment during handling
6.Follow standard pharmaceutical material handling procedures

Insulin Degludec Side Chain – Frequently Asked Questions (FAQ)

1. What is Insulin Degludec Side Chain?
Insulin Degludec Side Chain is a pharmaceutical intermediate used in the synthesis of long-acting insulin analogs, such as insulin degludec. It features a hexadecanedioic acid structure that enables the formation of stable insulin multi-hexamers, allowing for ultra-long, steady basal insulin release after injection.

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2. What is the function of the side chain in insulin degludec?
The side chain allows insulin molecules to self-associate into multi-hexamers, creating a slow-dissolving depot in subcutaneous tissue. This mechanism ensures continuous insulin delivery for over 42 hours, providing smoother glucose control and reducing hypoglycemia risk.

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3. What are the main applications of Insulin Degludec Side Chain?
It is primarily used as a key intermediate in the production of insulin degludec APIs for long-acting diabetes treatments. It is also suitable for peptide conjugation studies, biosimilar development, and formulation of advanced basal insulin analogs.

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4. What is the chemical structure of the Insulin Degludec Side Chain?
The molecule is based on hexadecanedioic acid, a C16 dicarboxylic acid, which serves as a linker to the insulin backbone. This structural modification enhances lipophilicity, stability, and prolonged pharmacokinetics.

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5. What are the advantages of using Insulin Degludec Side Chain?

• Enables extended insulin action (>42 hours)

• Provides steady, peakless glucose control

• Reduces hypoglycemic risk

• Supports once-daily or flexible dosing

• Enhances patient adherence and treatment outcomes

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6. What quality standards does your Insulin Degludec Side Chain meet?
Our product is manufactured under cGMP-compliant facilities and certified with ISO 9001, ISO 22000, HACCP, HALAL, GMPC, and U.S. GRAS recognition, ensuring full regulatory compliance and global market readiness.

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7. How do you ensure the purity and consistency of each batch?
Every batch undergoes comprehensive analytical testing using HPLC, MS, and NMR to verify:

• Structural integrity

• Chiral purity

• Molecular weight accuracy

• Absence of residual solvents and process impurities

This ensures batch-to-batch reproducibility and pharmaceutical-grade quality.

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8. What are the solubility and stability characteristics?
The side chain exhibits excellent solubility in organic solvents and maintains chemical stability under controlled temperature and humidity. It can be efficiently conjugated with insulin molecules without compromising molecular integrity.

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9. Is your Insulin Degludec Side Chain suitable for biosimilar or generic insulin production?
Yes. Our side chain is designed to support biosimilar manufacturing and generic insulin analog development, meeting the structural and functional requirements for regulatory equivalence to reference products.

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10. What documentation is available for regulatory submission?
We provide complete technical documentation including:

• COA (Certificate of Analysis)

• MSDS (Material Safety Data Sheet)

• TDS (Technical Data Sheet)

• Analytical and validation reports
  to support DMF filing, quality audits, and regulatory review.

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11. How should Insulin Degludec Side Chain be stored and handled?
Store in a cool, dry, and well-ventilated environment away from light and moisture. Recommended storage temperature: 2–8°C. Handle under inert conditions to maintain structural stability.

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12. Do you offer technical support or formulation guidance?
Yes. Our technical team provides R&D and process optimization support, assisting clients with synthetic route design, conjugation methods, and scale-up solutions for insulin analog production.