Semaglutide CAS#910463-68-2

Semaglutide CAS#910463-68-2

Semaglutide (CAS No.: 910463-68-2) - Novel GLP-1 Receptor Agonist For Type 2 Diabetes & Chronic Weight Management As a professional supplier of pharmaceutical-grade peptide active pharmaceutical ingredients (APIs), we provide high-purity Semaglutide that strictly complies with global pharmacopoeia standards (USP, EP, BP). A recombinant glucagon-like peptide-1 (GLP-1) receptor agonist, it exhibits long-acting glucose-lowering effects and weight-regulating properties by mimicking endogenous GLP-1—making it a core therapeutic agent for type 2 diabetes mellitus (T2DM) and chronic weight management in adults.
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Description

Semaglutide (CAS No.: 910463-68-2) - Novel GLP-1 Receptor Agonist for Type 2 Diabetes & Chronic Weight Management

As a professional supplier of pharmaceutical-grade peptide active pharmaceutical ingredients (APIs), we provide high-purity Semaglutide that strictly complies with global pharmacopoeia standards (USP, EP, BP). A recombinant glucagon-like peptide-1 (GLP-1) receptor agonist, it exhibits long-acting glucose-lowering effects and weight-regulating properties by mimicking endogenous GLP-1-making it a core therapeutic agent for type 2 diabetes mellitus (T2DM) and chronic weight management in adults.

Product Basic Information

Item Details
Product Name Semaglutide
CAS No. 910463-68-2
Synonyms Semaglutide (rDNA origin); (2S)-2-[[(2S,3S)-2-(3-(1-(4-chlorobenzyl)-5-isopropyl-1H-pyrazole-3-carboxamido)-2-hydroxypropanoyl]amino]-3-phenylpropanoic acid cyclic (1→16) amide with (4R)-4-[(3R)-3-hydroxydecano-yl]-1,4-thiazane-3-carboxylic acid
Molecular Formula C₁₈₇H₂₉₁N₄₅O₅₉
Molecular Weight 4113.58
Appearance White to off-white crystalline powder; Odorless
Specification Pharmaceutical grade; Purity ≥99.0% (HPLC); Loss on drying ≤3.0%; Residue on ignition ≤0.1%; Heavy metals (Pb, Hg, Cd) ≤10ppm; Solvent residue (e.g., acetonitrile, trifluoroacetic acid) compliant with ICH Q3C limits

Product Core Functions & Applications

Semaglutide CAS#910463-68-2 exerts its pharmacological effects by selectively activating GLP-1 receptors (expressed in the pancreas, brain, gastrointestinal tract, and adipose tissue). It enhances glucose-dependent insulin secretion (only stimulates insulin when blood glucose is elevated, reducing hypoglycemia risk), inhibits glucagon secretion, slows gastric emptying, and suppresses appetite-addressing both hyperglycemia and weight gain (a common comorbidity in T2DM). Its key advantage is a long half-life (~7 days), allowing once-weekly administration, which significantly improves patient compliance. It is exclusively used in human pharmaceutical formulations:

1. Type 2 Diabetes Mellitus (T2DM) Treatment

Monotherapy: For patients with T2DM who cannot tolerate or are unsuitable for first-line oral agents (e.g., metformin), it effectively lowers fasting and postprandial blood glucose, as well as glycated hemoglobin (HbA1c) by 1.5-2.0%.

Combination Therapy: Used with metformin, sulfonylureas, SGLT2 inhibitors, or insulin to further optimize glycemic control, while mitigating weight gain associated with insulin/sulfonylureas.

Cardiovascular Benefit: Reduces the risk of major adverse cardiovascular events (MACE, e.g., myocardial infarction, stroke) in T2DM patients with established cardiovascular disease or multiple cardiovascular risk factors.

2. Chronic Weight Management

Indicated for adults with a body mass index (BMI) ≥30 kg/m² (obesity) or BMI ≥27 kg/m² (overweight) with at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, T2DM).

Achieves sustained weight reduction (average 10-15% of baseline weight over 68 weeks) by suppressing appetite (via central nervous system effects) and delaying gastric emptying.

Dosage Forms

Injectable Formulations: Pre-filled pens (1.34 mg/mL, 0.5 mg/0.5 mL, 1.0 mg/0.5 mL) or multi-dose vials for subcutaneous injection (abdomen, thigh, upper arm), administered once weekly.

Oral Formulations: Used to prepare oral tablets (e.g., 3 mg, 7 mg, 14 mg) for patients who prefer non-injectable options, taken once daily on an empty stomach.

Quality & Safety Assurance

as a high-potency peptide API, requires rigorous quality control to ensure efficacy, stability, and safety:

Raw Material Sourcing & Production

Precursor Selection: Uses high-purity recombinant peptides and synthetic intermediates (e.g., 4-chlorobenzyl pyrazole derivatives) to avoid impurities that may affect receptor binding or trigger immune reactions.

Manufacturing Process: Produced in GMP-certified cleanrooms via advanced solid-phase peptide synthesis (SPPS) and post-translational modification (e.g., fatty acid conjugation to extend half-life). Strict control over coupling efficiency, deprotection, and purification (high-performance liquid chromatography, HPLC) ensures batch-to-batch consistency.

Comprehensive Testing Protocols

Each batch undergoes strict testing to meet pharmacopoeia standards:

Purity & Related Substances: HPLC analysis (purity ≥99.0%, single impurity ≤0.5%, total impurities ≤1.0%).

Peptide Content: Confirmed via amino acid analysis or UV-Vis spectroscopy.

Physical & Chemical Tests: Specific optical rotation, moisture content (Karl Fischer method), and pH (of aqueous solution).

Safety Tests: Heavy metal detection (ICP-MS), microbial limit testing (total aerobic microbial count ≤100 CFU/g), sterility testing (for injectable-grade API), and endotoxin testing (≤0.25 EU/mg).

Safety Reminders

Common Side Effects: Gastrointestinal reactions (nausea, vomiting, diarrhea, constipation)-usually mild to moderate, improving with dose escalation.

Serious Risks:

Pancreatitis: Monitor for persistent severe abdominal pain (with nausea/vomiting); discontinue if suspected.

Thyroid C-Cell Tumor Risk: Contraindicated in patients with personal/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).

Hypoglycemia: Risk increases when combined with insulin or sulfonylureas (reduce doses of these agents as needed).

Heart Rate Elevation: May cause mild, dose-dependent increases in resting heart rate; avoid in patients with uncontrolled tachycardia.

Contraindications: Hypersensitivity to Semaglutide or any excipients; MTC history/family history; MEN 2.

Cooperation & Contact

We supply pharmaceutical-grade Semaglutide API for manufacturers of injectable (once-weekly) and oral (once-daily) formulations, with flexible production capacities (from gram-level R&D samples to kilogram-level bulk orders). If you are a pharmaceutical enterprise, R&D institution, or formulator in need of this product, please contact us for:

Detailed pharmacopoeia compliance documents (USP/EP monograph confirmation, certificate of analysis).

Pricing quotes, bulk order discounts, and free sample requests (for R&D purposes).

Technical support (e.g., formulation compatibility, stability guidance for peptide APIs, dose escalation protocols).

Contact Information:

Email: sales@huarongpharma.com

Phone/WhatsApp: +86 13751168070

We adhere to the principles of "quality first, compliance-oriented" and look forward to establishing long-term, mutually beneficial cooperative relationships with global partners!

Frequently Asked Questions (FAQs)

1. What are the common side effects of Semaglutide?

The most common side effects are gastrointestinal reactions, including nausea (44-68% of patients), diarrhea (24-40%), vomiting (15-25%), constipation (15-30%), and decreased appetite (20-45%). These are typically mild to moderate, occur within the first few weeks of treatment, and often improve with gradual dose escalation or continued use. Less common side effects include fatigue, headache, and mild injection site reactions (redness, itching).

2. How does Semaglutide work in the body?

works by mimicking the action of endogenous GLP-1 (a gut hormone released after meals) and activating GLP-1 receptors in key organs:

Pancreas: Stimulates insulin secretion (only when blood glucose is high, avoiding hypoglycemia) and inhibits glucagon secretion (reduces glucose production by the liver).

Gastrointestinal Tract: Slows gastric emptying, which delays nutrient absorption and reduces postprandial blood glucose spikes.

Brain: Acts on the hypothalamus to suppress appetite and increase satiety, leading to reduced food intake and weight loss.

Long Half-Life: A fatty acid chain attached to the peptide binds to albumin in the bloodstream, slowing clearance and allowing once-weekly administration.

3.  Are There Any Drug Interactions With Semaglutide?
Yes, its ability to slow gastric emptying may affect the absorption of other oral medications. Key interactions include:

  • Oral Hypoglycemic Agents: When combined with insulin or sulfonylureas (e.g., glimepiride), the risk of hypoglycemia increases-reduce doses of insulin or sulfonylureas by 20–50% initially.
  • Oral Contraceptives: May delay absorption (peak concentration reduced by ~30%); administer contraceptives at least 30 minutes before for the oral form or at any time for the injectable form, as the effect is minimal.
  • Antibiotics/Antifungals: Drugs requiring rapid absorption (e.g., amoxicillin, fluconazole) should be taken 1 hour before or 2 hours after the oral form; no adjustment is needed for the injectable type.
  • Beta-Blockers: May mask hypoglycemia symptoms (e.g., tachycardia); monitor blood glucose closely.
  • Glucocorticoids: May reduce its glucose-lowering effect; increase glucose monitoring if co-administered.

 

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