"Tirzepatide API (CAS No. 2090032-40-6) – Properties, Uses, Synthesis, and Dosage Forms"

 

🌿 Q2. What is Tirzepatide API by Swapnroop Drugs & Pharmaceuticals used for? 🌿

Therapeutic Uses:

• Type 2 Diabetes Mellitus (T2DM) 🩸 – Tirzepatide is used as a once-weekly injectable therapy to control blood glucose levels and improve insulin sensitivity.

• Obesity and Weight Management ⚖️ – Under clinical investigation or approved in certain regions for reducing body weight in overweight or obese patients.

• Cardiometabolic Risk Reduction ❤️ – May aid in improving lipid profiles, reducing blood pressure, and decreasing cardiovascular risk factors in patients with T2DM.

• Mechanism Advantage: Dual GIP and GLP-1 receptor agonism helps enhance insulin secretion, reduce glucagon, slow gastric emptying, and suppress appetite, providing holistic metabolic control.

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🧪 Q3. What are the physicochemical properties of Tirzepatide API manufactured by Swapnroop Drugs & Pharmaceuticals? 🧪

• Chemical Name: Tirzepatide

• CAS Number: 2090032-40-6

• Molecular Formula: C₄₄₁H₆₉₁N₁₂₁O₁₃₆S₅

• Molecular Weight: ~4882 Da (peptide)

• Appearance: White to off-white lyophilized powder

• Solubility: Soluble in water; forms stable aqueous solutions under controlled pH and temperature

• Stability: Sensitive to moisture, temperature, and pH; requires cold-chain storage (2–8°C)

• Peptide Nature: Sensitive to enzymatic degradation and hydrolysis, necessitating careful handling and formulation

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⚙️ Q4. How is Tirzepatide API manufactured by Swapnroop Drugs & Pharmaceuticals synthesized? ⚙️

Tirzepatide is a 39-amino-acid peptide, so its synthesis involves advanced peptide manufacturing techniques:

1. Solid-Phase Peptide Synthesis (SPPS) 🧪 – Sequential addition of protected amino acids on a resin support to build the peptide chain.

2. Side-Chain Protection & Deprotection 🔒 – Ensures correct peptide folding and prevents unwanted reactions.

3. Cleavage from Resin & Cyclization (if applicable) ✂️ – Releases the full-length peptide from solid support.

4. Purification ✨ – High-performance liquid chromatography (HPLC) is used to achieve high purity (>98%).

5. Lyophilization ❄️ – Converts the purified peptide solution into a stable dry powder for injectable formulations.

6. Quality Control 🔬 – Identity, purity, sequence confirmation, and bioactivity tests ensure consistent API quality.

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💊 Q5. What are the different dosage forms of Tirzepatide API manufactured by Swapnroop Drugs & Pharmaceuticals? 💊

• Lyophilized Powder for Injection ❄️ – Reconstituted before administration.

• Pre-filled Injectable Pens 💉 – Ready-to-use once-weekly injections for patient convenience.

• Vials for Multi-dose or Single-use 🧴 – For clinical or hospital use, depending on formulation.

These dosage forms are optimized for subcutaneous administration, ensuring controlled absorption, patient compliance, and sustained therapeutic effect.

⚗️ Q6. How are Tirzepatide API dosage forms prepared? ⚗️

• Lyophilized Powder:

  • Tirzepatide API is dissolved in a suitable aqueous buffer with stabilizers (e.g., mannitol or polysorbates) 💧.

  • The solution is filtered, filled into vials or cartridges under sterile conditions 🧴.

  • Lyophilization (freeze-drying) is performed ❄️ to produce a stable dry powder suitable for long-term storage.

• Pre-filled Pens & Vials:

  • The lyophilized powder is reconstituted or formulated into ready-to-use injectable solutions.

  • Sterile filling and packaging ensure dose accuracy, patient safety, and usability 💉.

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✅ Q7. What is the appropriate dosage form of Tirzepatide API manufactured by Swapnroop Drugs & Pharmaceuticals? ✅

• Subcutaneous injection is the primary and approved route for Tirzepatide.

• Available as:

  • Pre-filled disposable pens 💉 – convenient for self-administration once weekly.

  • Lyophilized powder vials ❄️ – reconstituted before use in clinical settings.

• The appropriate form depends on patient preference, clinical setting, and required dose.

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🕒 Q8. When should Tirzepatide API manufactured by Swapnroop Drugs & Pharmaceuticals be taken? 🕒

• Frequency: Once weekly subcutaneous injection.

• Timing: Can be administered on the same day each week, with or without meals. ⏰

• Consistency: Regular weekly dosing is critical for maintaining glycemic control.

• Note: Tirzepatide is not for acute hypoglycemia treatment; it is a maintenance therapy for long-term management.

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🌬️ Q9. What are the effects and side effects of Tirzepatide API manufactured by Swapnroop Drugs & Pharmaceuticals? 🌬️

Therapeutic Effects:

• Lowers HbA1c and fasting glucose levels 🩸

• Promotes weight loss ⚖️ by appetite suppression and delayed gastric emptying

• Improves insulin sensitivity 💚

• May reduce cardiometabolic risk factors (lipids, blood pressure) ❤️

Common Side Effects:

• Gastrointestinal: nausea 🤢, vomiting 🤮, diarrhea 💦, constipation

• Injection site reactions: redness, itching, mild swelling 💉

• Rare: pancreatitis, hypoglycemia (usually when combined with insulin or sulfonylureas), allergic reactions ⚠️

Important Note: Benefits generally outweigh side effects when used under medical supervision, and dose titration is often applied to minimize GI discomfort.

🔬 Q10. How is Tirzepatide API manufactured by Swapnroop Drugs & Pharmaceuticals tested? 🔬

Tirzepatide API undergoes rigorous quality control to ensure purity, safety, and efficacy:

• Identity Tests 🧪 – Confirm chemical structure using Mass Spectrometry (MS), NMR, and HPLC.

• Peptide Sequence Verification 📜 – Ensures correct amino acid sequence via LC-MS/MS.

• Purity and Potency Assay 💊 – HPLC to confirm ≥98% purity and correct dosage strength.

• Impurity Analysis ⚗️ – Detection of residual solvents, truncated peptides, and process-related impurities.

• Moisture Content 💧 – Karl Fischer titration to maintain stability.

• Sterility Testing 🦠 – For injectable forms, ensures microbial contamination is absent.

• Stability Studies 📆 – Conducted under ICH guidelines (temperature, humidity, light) to determine shelf-life.

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🧪 Q11. What tests are performed on Tirzepatide API manufactured by Swapnroop Drugs & Pharmaceuticals? 🧪

In addition to routine QC testing, Tirzepatide undergoes:

• Peptide Folding/Secondary Structure Analysis 🧬 – Circular dichroism (CD) spectroscopy to verify correct alpha-helix formation.

• Endotoxin Testing 🧫 – Limulus Amebocyte Lysate (LAL) assay for injectable safety.

• Particle Size and Aggregation 🌬️ – Dynamic light scattering (DLS) to ensure homogeneity and prevent aggregation.

• pH and Buffer Compatibility ⚖️ – Ensures peptide stability in formulation solutions.

• Biological Activity Assays 🩺 – In vitro receptor binding or functional assays to confirm GIP/GLP-1 activity.

These tests guarantee safety, consistency, and therapeutic efficacy for clinical use.

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⚙️ Q12. What are the challenges in manufacturing Tirzepatide API by Swapnroop Drugs & Pharmaceuticals? ⚙️

Manufacturing Tirzepatide is complex due to its peptide nature:

1. Peptide Synthesis Complexity 🧪 – 39 amino acids require precise sequential assembly and high-yield reactions.

2. Purity and Impurity Control ✨ – Any truncated, oxidized, or misfolded peptide must be removed.

3. Stability Issues ❄️ – Sensitive to temperature, moisture, and pH; requires cold-chain storage.

4. Folding and Conformation 🧬 – Correct alpha-helix structure is critical for biological activity.

5. Analytical Challenges 🔬 – Accurate verification of sequence, purity, and bioactivity requires sophisticated instrumentation.

6. Regulatory Compliance 📜 – Must adhere to cGMP, ICH, and global pharmacopeial standards.

These challenges demand specialized expertise, controlled environments, and high-end analytical tools to consistently produce high-quality Tirzepatide API.

💊 Q13. What are the challenges in manufacturing Tirzepatide dosage forms by Swapnroop Drugs & Pharmaceuticals? 💊

Formulating Tirzepatide into injectable dosage forms presents several challenges:

1. Maintaining Peptide Stability ❄️ – Sensitive to temperature, pH, and moisture; requires cold-chain formulation and storage.

2. Accurate Dose Delivery 💉 – Injectable pens and vials must provide precise, reproducible dosing for patient safety.

3. Sterility Assurance 🦠 – All injectable formulations must be sterile, requiring aseptic processing and filtration.

4. Prevention of Aggregation 🧬 – Peptides can aggregate during storage; formulation must ensure homogeneity and solubility.

5. Patient Usability & Compliance 👵👨‍🦳 – Devices must be easy to use and minimize injection errors.

6. Compatibility with Excipients ⚗️ – Stabilizers, buffers, and surfactants must not affect peptide activity.

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🌡️ Q14. What are the storage conditions for Tirzepatide API manufactured by Swapnroop Drugs & Pharmaceuticals? 🌡️

• Temperature: Store at 2–8°C (refrigerated) ❄️

• Protection from Light & Moisture: Keep in airtight, light-resistant containers 💧☀️

• Handling: Avoid repeated freeze-thaw cycles; use appropriate sterile techniques.

• Transport: Cold-chain logistics must be maintained to preserve peptide integrity and potency.

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📦 Q15. What is the packaging for Tirzepatide API manufactured by Swapnroop Drugs & Pharmaceuticals? 📦

• Lyophilized Vials 🧴 – For reconstitution in sterile diluents before administration.

• Pre-filled Injectable Pens 💉 – Ready-to-use, patient-friendly once-weekly doses.

• Secondary Packaging: Cartons with desiccants and protective inserts to maintain stability.

• Labeling: Includes storage instructions, batch number, and expiration date for regulatory compliance.

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⏳ Q16. What is the shelf life of Tirzepatide API manufactured by Swapnroop Drugs & Pharmaceuticals? ⏳

• Typical Shelf Life: 12–24 months under recommended storage conditions (2–8°C) ❄️

• Post-Reconstitution: Stability depends on formulation; usually 24–48 hours at 2–8°C or as per product-specific guidelines.

• Expiry Monitoring: Regular stability studies ensure retention of potency, purity, and bioactivity over the declared shelf life.

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