Sitagliptin API Powder
CAS.NO:486460-32-6
structural formula:C16H15F6N5O
EINECS.no:690-730-1
Other names:Sitagliptin base;Sitagliptin-D4;Sitagliptin-D4 HCL;
Test Method:HPLC/UV/GC-MS
MOQ & Package: 10g,100g,1kg,5kg,10kg,25kg etc
Customer's rights and interests:Over 10kg, you can enjoy the service of giving away free samples.
Certificate：FDA,ISO,COA, HPLC, MSDS,TDS etc
Lead Time: 1-3 days
Shipping: DHL,Germany DHL,Germany DPD,UPS,USPS,FedEx,EMS,By Air,By Sea,multimodal transport etc
Store & Shelf life; Cool & dry place; 36 months
Company advantages: there are self-built overseas warehouses and third-party overseas warehouses on all continents.
- Product Description
Xi'an Faithful BioTech Co., Ltd: Your Trusted Sitagliptin API Powder Manufacturer & Supplier
Sitagliptin API Powder is a new type of anti type II diabetes pharmaceutical raw material developed by an American company. It is the first dipeptidyl peptidase - Ⅳ (DPP - Ⅳ) inhibitor used to treat type II diabetes, often in the form of Sitagliptin phosphate. It was launched in Mexico and the United States in 2006 and received approval from the European Union in 2007. The advantages of Sitagliptin BASE provided by Xi'an Faithful BioTech Co., Ltd are even more apparent, as it has fewer side effects (such as lower likelihood of hypoglycemia and weight gain) in controlling blood glucose levels. Although safety is its advantage, its effectiveness cannot be guaranteed, so it is generally recommended to use it in combination with other similar pharmaceutical ingredients, such as Metformin 657-24-9.
Sitagliptin API Powder Introduction
Sitagliptin API Powder is a dipeptidyl peptidase IV (DPP-4) inhibitor. According to relevant research, dipeptidyl peptidase IV is the main enzyme responsible for the degradation of glucagon like peptide-1 (GLP-1) analogs, which are important gastrointestinal hormones (such as glucagon) that can increase pancreatic secretion of glucose dependent insulin. In the experiment, we can find that it can help control the blood sugar of type II diabetes patients by prolonging the action time of GLP-1, thereby increasing the level of active incretin and reducing blood sugar. It can be seen from clinical data that in the process of coping with type 2 diabetes, it can inhibit the activity of DPP-4 enzyme within 24 hours, thus increasing the circulating concentration of active GLP-1 and GIP by 2 to 3 times, increasing the plasma levels of insulin and C-peptide, reducing the level of glucagon, reducing fasting blood glucose and reducing the glucose load taken or the blood glucose fluctuation after eating.
Specifications
Item | Specifications | Results |
Appearance | White or light yellow powder | Complies |
Content | ≥ 98.00% | 98.82% |
boiling point | ≥ 114℃ | 118℃ |
HEAVY METAL | ≤ 5ppm | ≤ 0.32 ppm |
Total Plate Count | ≤1000cfu/g | 13.6 cfu/g |
Total Yeast & Mold | ≤100cfu/g | 0.28 cfu/g |
E. Coli | Negative | Negative |
Salmonella | Negative | Negative |
Staphylococcus | Negative | Negative |
| Conclusion | Conform with enterprise specification （USP 41）. |
Why Choose Us?
1.Strong hypoglycemic effect and rapid compliance: For newly diagnosed patients with hyperglycemia (glycated hemoglobin ≥ 9%), the combination therapy of sitagliptin and metformin has shown comparable hypoglycemic efficacy to the classic sulfonylurea pharmaceutical raw materials glimepiride in clinical studies in 2025, which can help patients quickly achieve blood glucose compliance.
2.Intelligent regulation and safe sugar control: As a DPP-4 inhibitor, sitagliptin regulates insulin and glucagon secretion in a blood glucose dependent manner by prolonging the body's own "intestinal glucagon" effect. The risk of hypoglycemia is significantly lower in monotherapy compared to traditional hypoglycemic pharmaceutical raw materials.
3.Weight neutral and metabolism friendly: Compared to traditional hypoglycemic drugs such as sulfonylureas and insulin that may cause weight gain, Sitagliptin phosphate has the advantage of being "weight neutral", which means it effectively lowers blood sugar without significantly affecting the patient's weight, and is more in line with the needs of comprehensive metabolic management.
4.Cooperate with insulin to optimize treatment safety: for patients with type 2 diabetes who need insulin treatment, the combination of sitagliptin can further improve the effect of blood glucose control without increasing the risk of hypoglycemia, and even some studies have shown that it can reduce the related risks and provide a safer intensive program for insulin treatment.My email is: sales8@faithfulbio.com ,Welcome to the store for inquiries.
Adverse reaction
Adverse reactions of Sitagliptin API Powder include headache, nausea, and rash, but they are not common. The use of sitagliptin alone generally does not cause hypoglycemia (<1%), but when combined with other hypoglycemic pharmaceutical ingredients, the frequency of hypoglycemia is higher. At present, there have been very few cases of acute pancreatitis caused by the use of sitagliptin, and the situation is very serious.
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FAQ
Q1.: What is the quality standard of sitagliptin API?
The quality standard of sitagliptin API powder requires that the content is ≥99.0%, the related substances are ≤1.0%, the loss on drying is ≤1.0%, the ignition residue is ≤0.1%, the heavy metal is ≤10ppm, and the pH value of acidity is 3.0-4.5. The appearance of the product is white to white-like crystalline powder, odorless and tasteless. It must meet the international pharmacopoeia standards such as CP, USP and BP.
Q2.: How to detect related substances?
Detected by high performance liquid chromatography (HPLC). It is required that its peak retention time is about 27 minutes, and the separation degree between its peak and impurity I peak (relative retention time is about 0.9) should be greater than 2.0. The peak area of impurity I multiplied by the correction factor of 1.3 shall not be greater than 0.1% of the main peak area of the control solution, the peak area of other single impurities shall not be greater than 0.1%, and the total impurities shall not be greater than 0.3%.
Q3.: What are the storage conditions of sitagliptin?
It should be shaded, sealed and stored in a cool and dry place. The Sitagliptin BASE powder can be stored at-20 C for 3 years and at 4 C for 2 years. After being dissolved in solvent, it can be stored at-80 C for 6 months and at-20 C for 1 month. The transportation condition is room temperature, but it is recommended to put it in an ice pack to keep the product quality.
Contact us
Sitagliptin API powder is the first DPP-4 inhibitor listed in the world, with global sales of $6.695 billion, $7.886 billion and $6.982 billion in 2020-2023, and sales of $8.838 billion in 2024. With the rising prevalence of diabetes in the world, its market demand will increase steadily at a faster speed.If you hope to make achievements during this period, please leave a message, Our email address is:sales8@faithfulbio.com).
