FDA Certified Semaglutide Tirzepatide Retatrutide 5mg 10mg 20mg Vial Lyophilized Powder

• CAS No.: 910463-68-2
• Formula: C187h291n45o59
• EINECS: Na
• Type: Active Pharmaceutical Ingredient
• Appearance: Powder
• Quality: High-Purity
• Model NO.: 910463-68-2
• Colour: White
• Purity: > 99%HPLC
• Bacterial Endotoxins: Nmt 10 EU/Mg
• Total Aerobic Microbial Count: Nmt 10 Cfu/G
• Total Yeasts and Molds Count: Nmt 10 Cfu/G
• Escherichia Colo Count: Absent in 1g
• Molecular Formula: C187h291n45o59
• Relative Molecular Mass: 4113.64 G/Mol
• Long-Term Storage: -20 ± 5°c
• Transport Package: Box/Kit/Tube
• Specification: 2mg/5mg/10mg/15mg/20mg/30mg
• Trademark: GMP
• Origin: Cn, USA
• Production Capacity: 100000 Vials Per Month

Product Description

Manufacture of peptide APIs according to GMP regulations.

 

PRODUCT	Semaglutide
SEQUENCE	H-His-Aib-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Val-Ser-Ser-Tyr-Leu-Glu-Gly-Gln-Ala-Ala-Lys(AEEAc-AEEAc-γ-Glu-carboxyheptadecanoyl)-Glu-Phe-Ile-Ala-Trp-Leu-Val-Arg-Gly-Arg-Gly-OH
FIELDS OF APPLICATION	Treatment of type II diabetes mellitus Treatment of obesity
ACTIVE SUBSTANCE	The peptide API Semaglutide acts in the same way as GLP-1, the hormone produced in the gut. It helps increase the amount of insuli released by the pancreas in response to consumed food. Semaglutide allows patients with type 2 diabetes to control their blood sugar levels better.
MOLECULAR FORMULA	C187H291N45O59
RELATIVE MOLECULAR MASS	4113.64 g/mol
CAS-NUMBER	910463-68-2
PURITY	>99% HPLC
LONG-TERM STORAGE	-20 ± 5°C

Semaglutide is a lipopeptide with a linear sequence of 31 amino acids. Like human Glucagon-like peptide-1 (GLP-1), it is used in combination with diet and exercise in the therapy of type 2 diabetes mellitus. It works as an anti-obesity agent, a neuroprotective agent, and an appetite depressant.
Semaglutide can be commercialized as a synthetic generic product after approval of an abbreviated new drug application (ANDA) or comparable applications with other regulatory authorities. The length and modifications make technical excellence and regulatory expertise a prerequisite for efficient filing and fast approval. High material quality and yield, robust processes including secure supply and innovative approaches at high-tech facilities will enable our customers to achieve their business goals.

ZB Bio has a long-standing track record in with successful registrations of highly purified synthetic peptide drugs of the glucagon family. Our regulatory intelligence keeps track of important changes in the relevant legislation. This enables us to be a leading global innovator in the field of glucagon and glucagon-like synthetic peptide drugs. Our services have been optimized to shorten timelines and of reduce complexity for our clients.

FROM SMALL TO LARGE-SCALE PRODUCTION WITH HIGH QUALITY 

Our high-tech Good Manufacturing Practice (GMP) facilities based in Zhejiang province china, plus the commitment of our technical and scientific experts to quality, are the cornerstones for continuous compliance. We deliver small-scale to multi-kg active pharmaceutical ingredients (APIs) with impurities below 0.5%, identification and characterization of impurities above 0.10% using orthogonal analytical techniques.

 

OPTIMIZED, AUTOMATED HIGH-YIELD PRODUCTION

Our long experience in complex APIs allows us to optimize the processes for high yields at outstanding quality. Our high level of process automation allows for cost-efficient and large-scale production resulting in excellent overall material purity (>99.5%). Innovative solutions like continuous chromatography let us use equipment and resources more efficiently and help us and our partners to achieve their commitment to sustainability and environment-friendly production.
 

OUR TIMELINES FOR SEMAGLUTIDE

ROBUST PROCESSES AND SUPPLY SECURITY

Having our in-house building blocks for peptide synthesis as well as long-term cooperation with trusted suppliers ensures on-time production. Redundancy of multi-purpose equipment and facilities helps to mitigate risks in the supply chain, together with our stock of finished APIs and is the key for on-time product deliveries to our customers. 
 

RELATED PRODUCTS (FOR RESEARCH PURPOSES ONLY)

Beyond GMP-grade semaglutide, we provide semaglutide in research grade, variants thereof and in different salt forms.

CERTIFICATE OF ANALYSIS

Product Name	Semaglutide	Sample Source		Workshop 106
Batch Number	LX106S2305107	Packing Size		131.03g/bag, 401.6g/bag, 477.57g/bag
Quantity	1010.2g	Manufacturing Date		Apr-10-2023
Number of Packages	3	Retest Date		Apr-09-2025
Sample Date	Apr-28-2023	Report Date		May-08-2023
Testing Reference	QC-03-1003-02, QC-02-1595-03
TEST ITEM	SPECIFICATION		TEST RESULT
Appearance	White or almost white loose powder		white loose powder
Solubility	Freely soluble in water, soluble in DMF at 1 mg/mL, 30 mg/mL in DMSO, 0.2 mg/ml in a 1:4 solution of DMSO:PBS		conforms
Identification (MS)	4111.12±0.5Da		4111.15
Identification (HPLC)	Examine the chromatograms obtained in the assay. The principal peak in the chromatogram obtained with the test solution is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution.		conforms
Specific Optical Rotation [α]^20D (anhydrous substance)	-6.0° to -16.0°		-10.3°
Purity (HPLC)	NLT 98.0%		99.47%
Water Content	NMT 8.0%		3.9%
pH	7.0 to 9.0		7.9
Solution Clarity and Color	Clear and colorless		conforms
Acid Group Ions	Trifluoroacetate ion NMT 0.1%		N.D.
	Phosphate ion NMT 0.1%		N.D.
	Chloride ion NMT 0.1%		0.003%
	Acetate ion NMT 0.1%		N.D.
Sodium Ion	NMT 4.0%		2.1%
Related Substances I	SPEC054-Z18 NMT 0.50%		N.D.
	SPEC054-Z20 NMT 0.30%		0.03%
	SPEC054-Z21 NMT 0.50%		N.D.
	SPEC054-Z57 NMT 0.20%		N.D.
	Any other impurities NMT 0.10%		0.02%
	Total impurities NMT 1.0%		0.08%
Related Substances II	SPEC054-Z19 NMT 0.30%		0.02%
	SPEC054-Z23 NMT 0.20%		0.03%
	SPEC054-Z69 NMT 0.20%		N.D.
	Total related substances I and II NMT 1.50%		0.12%
Amino Acid Analysis	Asp:0.8-1.2		1.1
	His:0.8-1.2		1.0
	Tyr: 0.8-1.2		1.2
	Lys: 0.8-1.2		1.0
	Ile: 0.8-1.2		1.0
	Aib: 0.8-1.2		0.8
	Leu: 1.6-2.4		2.2
	Val: 1.6-2.4		2.1
	Arg: 1.6-2.4		2.0
	Thr: 1.6-2.4		1.9
	Phe: 1.6-2.4		1.9
	AEEA: 1.6-2.4		1.7
	Ser: 2.4-3.6		2.8
	Ala: 2.4-3.6		3.0
	Gly: 3.2-4.8		4.0
	Glu: 4.0-6.0		5.2
	Trp (Partially destroyed during acid hydrolysis)		detected
Bacterial Endotoxins	2 EU/mg		< 2 EU/mg
Microbial Limits	Total aerobic microbial count NMT 100 cfu/g		< 10 cfu/g
	Total yeasts and molds count NMT 50 cfu/g		< 10 cfu/g
	Escherichia coli count		Absent in 1g
Conclusion: This batch of product COMPLIES with the prescribed standards.
Storage condition: -20°C ± 5°C, well-closed containers, protected from light.

HPLC TEST REPORT

3rd LAB TEST REPORT

Packaging & Shipping