Semaglutide Raw Powder

Semaglutide Raw Powder

Details
Product Name: Semaglutide Raw Powder
Specification: ≥98%
Test Method: HPLC
CAS No: 910463-68-2
MF: C187H291N45O59
MW: 4,113.64 g/mol
Deliver Time:Around 2-3weeks MOQ:1kg Payment Way:T/T L/C Paypal Shelf life:2 years
Packing:1kg/bag,25kg/drum,Customization available
Category
Nutritional Supplements
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Description
Technical Parameters

What is Semaglutide Raw Powder ?

 

Semaglutide Raw Powder is a high-purity GLP-1 receptor agonist peptide active pharmaceutical ingredient (API) widely used in the pharmaceutical and biotechnology industries. It is primarily utilized in the development of medications for metabolic disorders, glucose regulation, and weight-management therapies.

For pharmaceutical manufacturers, research institutions, and biotechnology companies, high-quality semaglutide raw material is essential for ensuring product consistency, bioactivity, and regulatory compliance. Bulk semaglutide powder is typically produced under strict quality control standards and supplied for drug development, formulation research, and pharmaceutical manufacturing.

With the global demand for metabolic health solutions continuing to grow, semaglutide has become one of the most important peptide APIs in modern pharmaceutical research and therapeutic innovation.

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Main Active Ingredients

 

 

The primary active compound in this product is Semaglutide peptide, a long-acting GLP-1 receptor agonist.

Component

Specification

Function

Semaglutide Peptide

≥98% purity (HPLC)

GLP-1 receptor agonist activity

Molecular Formula

C187H291N45O59

Peptide structure

Molecular Weight

~4113.6 g/mol

Large peptide molecule

Appearance

White or off-white powder

Pharmaceutical raw material

Solubility

Soluble in water / buffers

Suitable for formulation

 

COA

 

 

ITEMS

SPECIFICATIONS

RESULTS

Appearance

White or almost white loose powder

White loose powder

Solubility

Freely soluble in water; Firstly,to add freshly boiled and cooled water to make a clear solution containing 0.15mg of semaglutide in 1ml.Then,to adjust the pHof the solution to 5.5 with 0.05M hydrochloric acid and keep for 30 secondsFinally,to adjust the pH of the solution to 3.0 and keep 30 seconds.The solution should be turbid in the rang of pH 3.0 to 5.5.

Conforms

Specific optical rotation[a]²D

-15.0°to-10.0°(anhydrous and sodium ion-free substance,C=10mg/ml,H₂O)

-13.9°

Identification By HPLC

The retention time of the principal peak of the test solution corresponds to that of the reference solution,as obtained in the Assay.

Conforms

Molecular Ion Mass

4113.58±1.0

Conforms

Amino acid contect

Asp:0.9-1.1
Ser:2.7-3.3
Glu:4.5-5.5
Gly:3.6-4.4
His:0.9-1.1
Arg:1.8-2.2
Thr:1.8-2.2
Ala:2.7-3.3
Aib:0.9-1.1
Tyr:0.9-1.1
Val:1.8-2.2
Lys:0.9-1.1
Ile:0.9-1.1
Leu:1.8-2.2
Phe:1.8-2.2
AEEA:Should be detected

1.0
3.0
5.0
4.0
1.0
2.0
2.0
3.0
1.1
1.0
1.9
1.0
1.0
2.0
2.0
Conforms

pH

7.0-9.0

7.5

Water Content (K.F)

NMT 8.0%

5.3%

Solution clarity and color

Clear and colorless

Conforms

Related substances(HPLC)

Impurity A:NMT0.3%
Impurity D:NMT0.3%
Impurity E:NMT 0.1%
Any individual impurity:NMT 0.1%
Total impurities:NMT1.5%

N.D
N.D
N.D
0.06%
0.3%

Related substances(HPLC)

Impurity B:NMT0.1%
Impurity C:NMT0.1%

0.02%
0.05%

Sodium ion

1.5%~4.0%

2.2%

High molecular protein

NMT 0.5%

0.03%

Residual solvent

Methylene chloride NMT 600ppm
Acetonitrile NMT 410ppm
Methanol NMT 3000ppm
DMF NMT880ppm
Isopropyl ether NMT 5000ppm
Isopropanol NMT 5000ppm

N.D
12ppm
N.D
N.D
N.D
N.D

Bacterial Endotoxins

NMT 10EU/mg

Conforms

Microbial Limits

TAMC NMT 200cfu/g
TYMC NMT 100cfu/g

<10cfu/g
<10cfu/g

Acid group ions

Trifluoroacetate ion NMT0.1%
Phosphate ion NMT 0.1%
Chloride ion NMT 0.1%
Acetate ion NMT 0.1%

N.D
N.D
0.01%
N.D

Assay

95.0%-105.0%(Calculated with reference to the anhydrous and sodium ion-free substance.

100.0%

Storage

Keep in tight container,protect from light,store at a temperature of-20±5℃.

Conclusion: This batch of product complies with Enterprise Standard.

 

Characteristics of Semaglutide Raw Powder

 

 

1. Highly Purified Peptide Raw Material with Strong Structural Stability

Semaglutide raw powder is a high-purity peptide active pharmaceutical ingredient (API), composed of 31 amino acids with fatty acid chain modifications at specific positions, resulting in a more stable molecular structure and greater resistance to enzymatic degradation. Compared to natural GLP-1, this structural optimization significantly extends its in vivo half-life, allowing it to maintain biological activity for a longer period. The raw powder undergoes rigorous purification processes, including molecular sieving, reversed-phase chromatography, and aseptic treatment, typically achieving a high purity standard of 95%–99%, ensuring the safety and efficacy of subsequent formulation development.

2. Potent GLP-1 Receptor Agonist Properties

Semaglutide, as a GLP-1 receptor agonist, possesses receptor binding capacity similar to or even stronger than that of endogenous human GLP-1. It can enhance glucose-dependent insulin secretion, reduce glucagon release, delay gastric emptying, and increase satiety. Therefore, semaglutide raw material powder is mainly used in drug development for the production of antidiabetic formulations and weight management prescription drugs. Its molecular properties determine that it can not only improve glycemic control but also influence metabolic behavior, which is an important reason for its extensive research.

 

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3. High Stability and Good Processing Adaptability

Semaglutide raw powder, after lyophilization, forms a highly stable white or off-white powder, facilitating storage, transportation, and further processing. Its fatty acid-modified structure makes it suitable for formulation into long-acting injectable dosage forms-such as once-weekly clinical preparations. In pharmaceutical processes, it can be used synergistically with various pharmaceutical excipients such as buffer salts, stabilizers, and biocompatible solvents to ensure the bioavailability and stability of the finished drug. The powder itself is sensitive to light, temperature, and humidity, therefore it usually needs to be stored in a low-temperature, airtight environment to maintain its activity.

4. A Strictly Regulated Prescription-Grade Raw Material

As an active pharmaceutical ingredient (API), semaglutide raw powder is strictly regulated by drug regulatory agencies in various countries and can only be legally purchased by laboratories or pharmaceutical companies with drug manufacturing qualifications for use in prescription drug production or research projects. Its use must adhere to strict quality management standards (such as GMP and GLP) and be subject to professional medical supervision before clinical application. The raw material powder cannot be used in food, health products, for personal use, or in any non-professional field, nor can it be prepared or used independently. This regulatory nature is one of its core characteristics.

 

Application of Semaglutide Raw Powder

 

 

Application Field

Practical Example

Main Function

Application Description

Pharmaceutical Manufacturing

Injectable GLP-1 receptor agonist medications

Metabolic regulation

Semaglutide raw powder is used as a key active pharmaceutical ingredient (API) in the development and manufacturing of peptide drugs designed for metabolic disorder management and glucose regulation.

Biotechnology Research

GLP-1 receptor pathway studies

Receptor activation research

Research institutions use semaglutide powder to investigate GLP-1 receptor signaling pathways, peptide stability, and pharmacological mechanisms in metabolic research.

Drug Development Programs

Clinical trial formulations

Therapeutic innovation

Pharmaceutical companies incorporate semaglutide APIs during preclinical and clinical development to evaluate safety, efficacy, and pharmacokinetics of new peptide-based therapies.

Analytical Laboratories

Reference standards for peptide analysis

Quality control testing

Semaglutide powder can serve as a reference compound in analytical laboratories for method validation, peptide identification, and purity testing using HPLC or mass spectrometry.

Peptide Technology Development

Structural modification research

Peptide optimization

Scientists and biotechnology companies study semaglutide to explore peptide engineering techniques that improve bioavailability, receptor affinity, and metabolic stability.

Pharmaceutical R&D Collaboration

Contract research and formulation development

Drug formulation studies

Contract research organizations (CROs) and pharmaceutical R&D teams use semaglutide raw material for formulation testing, stability studies, and peptide drug delivery system development.

 

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Production Process of Semaglutide Raw Powder

 

 

The production of semaglutide requires advanced peptide synthesis technology and strict pharmaceutical-grade quality control.

1. Solid-Phase Peptide Synthesis (SPPS)

Semaglutide is primarily produced using solid-phase peptide synthesis, a widely used method for manufacturing complex therapeutic peptides. During this stage, amino acids are sequentially assembled on a solid resin to form the peptide chain.

2. Peptide Chain Assembly

The peptide sequence is built step-by-step through protected amino acid coupling reactions. Each step undergoes monitoring to ensure accurate chain formation and minimal impurities.

3. Cleavage and Deprotection

Once the peptide chain is fully assembled, it is cleaved from the resin and protective groups are removed to yield the crude peptide product.

4. Purification

The crude peptide undergoes purification through high-performance liquid chromatography (HPLC) to achieve high purity levels typically above 98%.

5. Lyophilization (Freeze Drying)

After purification, the peptide solution is freeze-dried to obtain stable semaglutide powder, which ensures improved storage stability and ease of transportation.

6. Quality Control

Each batch is tested according to strict pharmaceutical standards:

· HPLC purity analysis

· Mass spectrometry confirmation

· Peptide sequence verification

· Residual solvent testing

· Microbial and endotoxin testing

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FAQ

 

Q1: What is Semaglutide Raw Powder used for?

A: Semaglutide raw powder is primarily used as a pharmaceutical active ingredient (API) for drug development, biotechnology research, and metabolic disease therapeutic programs.

Q2: What purity level is typically available for semaglutide powder?

A: High-quality semaglutide raw powder is generally supplied with ≥98% purity verified by HPLC analysis.

Q3: What production method is used to manufacture semaglutide?

A: Semaglutide is produced through solid-phase peptide synthesis (SPPS) followed by purification using high-performance liquid chromatography.

Q4: How should semaglutide raw powder be stored?

A: The peptide should be stored at −20°C in sealed containers to maintain stability and prevent degradation.

Q5: Who typically purchases semaglutide raw powder?

A: Typical buyers include pharmaceutical manufacturers, biotechnology companies, peptide research laboratories, and drug development organizations.

Where to buy Semaglutide Raw Powder?

 

 

Pure Biological provides high-quality Semaglutide Raw Powder, supports customer OEM customization, from samples to bulk goods, can respond quickly, and has a good service foundation.

Please contact us by email for more information.Email:sales@pureabio.com

 

Certifications

 

 

Purea Biological Technology Co., Ltd. focuses on plant extracts and biopharmaceuticals, backed by authoritative certifications including ISO9001 and SC. We adhere to global quality standards, implement full-chain quality control, and deliver compliant, reliable products to support overseas partners in food, health products and pharmaceutical fields.

 

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Production Environment

 

 

Purea Biological Technology Co., Ltd. boasts a modern production base equipped with advanced equipment and technology. From raw material selection to extraction, separation, and purification, we strictly adhere to standard procedures to ensure the reliable quality of each batch of products. We have extremely strict quality control and a comprehensive quality control system. We rigorously control the quality of raw materials from the source, monitor the entire production process, and use advanced equipment to carefully inspect finished products.

Production Environment

 

Delivery Methods, Payment Way

 

 

Delivery Methods Payment Way

Packages

 

 

Packages

 

 

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