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Specifications
| Appearance: | White or off white powder |
| Assay (HPLC): | 99–101% |
| Identification: | Infrared absorption |
| Water: | 4% max |
| Related impurity – Any individual impurity: | 0.5% max |
| Related impurity – Total impurities: | 1% max |
Transport Information
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H.S. Code |
2933599053999 |
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Stability & Reactivity |
The product is chemically stable under standard ambient conditions. |
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Storage |
Tightly closed. Store in a closed, dry, ventilated place |
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Condition to Avoid |
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Package |
Manufacturing Information
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Capacity |
100kg/month |
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Experience |
Production since 2009 |
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Stock |
Applications
1.1 Treatment of Type 2 Diabetes Mellitus
Sitagliptin HCl monohydrate is a first-in-class DPP-4 inhibitor used to:
Improve glycemic control in adults with type 2 diabetes mellitus (T2DM)
Be prescribed alone or in combination with other antidiabetic agents like:
Metformin
Sulfonylureas
Thiazolidinediones (e.g., pioglitazone)
Insulin
It is not used for type 1 diabetes or diabetic ketoacidosis.
1.2 Oral Antidiabetic Agent
Unlike insulin or injectable GLP-1 analogs, sitagliptin is orally bioavailable and suitable for:
Outpatient long-term use
Patients who prefer oral tablets over injections
1.3 Fixed-Dose Combination Products
Sitagliptin is often formulated in fixed-dose combinations such as:
Sitagliptin + Metformin (brand name: Janumet®)
These combinations simplify therapy and improve patient compliance.
1.4 Investigational and Adjunctive Use
Ongoing research investigates sitagliptin for potential benefits in:
Cardiovascular protection
Weight management
β-cell preservation
Inflammatory modulation in metabolic syndrome
Benefits
2.1 DPP-4 Inhibition Mechanism
Sitagliptin works by inhibiting the enzyme dipeptidyl peptidase-4 (DPP-4), which:
Increases levels of incretin hormones (GLP-1 and GIP)
Enhances glucose-dependent insulin secretion
Suppresses glucagon release
Helps lower postprandial and fasting blood glucose
2.2 Weight-Neutral and Low Hypoglycemia Risk
Unlike sulfonylureas or insulin:
Sitagliptin is weight neutral
Has a low risk of hypoglycemia, especially when not used with sulfonylureas or insulin
2.3 Once-Daily Dosing
It has a long half-life (~12.4 hours), allowing once-daily dosing, which:
Enhances patient convenience
Improves adherence to treatment
2.4 Renal Safety and Dosage Adjustment
While sitagliptin is primarily renally excreted, it is generally well tolerated in patients with mild to moderate renal impairment, with appropriate dose adjustments.
2.5 Well-Tolerated with Mild Side Effects
Common side effects are mild and may include:
Nasopharyngitis
Headache
Upper respiratory tract infections
Rare but serious adverse effects (e.g., pancreatitis, hypersensitivity reactions) are infrequent with proper patient monitoring.
Conclusion
Sitagliptin HCl monohydrate (CAS 862156-92-1) is a cornerstone in the modern management of type 2 diabetes mellitus due to its targeted mechanism, patient-friendly oral administration, and favorable safety profile. By enhancing the body's natural incretin system through DPP-4 inhibition, sitagliptin helps regulate glucose levels without causing significant hypoglycemia or weight gain. Its integration into combination therapies and fixed-dose regimens further strengthens its role in personalized diabetes care. With growing research into its extended benefits beyond glucose control, sitagliptin continues to be a vital tool in combating the global burden of type 2 diabetes.
