Sitagliptin Powder Cas No.486460-32-6
Product Source: Synthetic
Product Specification: ≥99% CAS No.: 486460-32-6
Molecular Formula: C₁₆H₁₅F₆N₅O
Molecular Weight: 407.31
Testing Method: HPLC
Active Ingredient: Sitagliptin
Product Characteristics: White to off-white crystalline powder
Product Packaging: 1kg/bag; 25kg/drum
Storage Conditions: Store in a dry, sealed container protected from light
Shelf Life: 24 months
What is High-Purity Sitagliptin API Powder (CAS 486460-32-6)?
High-Purity Sitagliptin API Powder | CAS 486460-32-6
Sitagliptin (CAS No. 486460-32-6) is a potent, orally active, highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor utilized as a foundational Active Pharmaceutical Ingredient (API) for type 2 diabetes management. Manufactured under rigorous cGMP-compliant protocols at Xi'an Tihealth, our Sitagliptin crystalline powder achieves a validated HPLC purity of ≥99.0%. By preventing the degradation of incretin hormones, it facilitates glucose-dependent insulin secretion and suppresses glucagon release. This pharmaceutical-grade API is optimized for the production of oral solid dosage forms (e.g., Januvia™ generic equivalents), ensuring exceptional batch-to-batch consistency and meeting the stringent monographs of USP and EP for industrial formulation.
What are the core technical specifications (TDS)?
| Parameter | Product Specification |
|---|---|
| Chemical Name | (3R)-3-amino-1-[3-(trifluoromethyl)-6,8-dihydro-5H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one |
| CAS Number | 486460-32-6 |
| Molecular Formula | C₁₆H₁₅F₆N₅O |
| Molecular Weight | 407.31 g/mol |
| Assay (HPLC, Anhydrous) | ≥ 99.0% |
| Appearance | White to off-white crystalline powder |
| Shelf Life | 24 Months |
What is the pharmacological mechanism of action?
Sitagliptin regulates glucose homeostasis via the potentiation of the incretin system:
- DPP-4 Inhibition: Sitagliptin competitively inhibits the enzyme dipeptidyl peptidase-4 (DPP-4), which is responsible for the rapid inactivation of incretin hormones, namely GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide).
- Incretin Hormone Potentiation: By extending the half-life of active GLP-1 and GIP, it enhances glucose-dependent insulin secretion from pancreatic beta cells and suppresses inappropriately high glucagon secretion from alpha cells.
- Hepatic Glucose Regulation: The synergistic effect results in reduced hepatic glucose production and improved postprandial and fasting blood glucose levels without causing weight gain or significant hypoglycemia risk.
What are the primary pharmaceutical applications?
- Monotherapy & Combination Dosages: The foundational API for manufacturing 25mg, 50mg, and 100mg tablets, as well as fixed-dose combinations with Metformin (e.g., Janumet™ types).
- Generic Formulation Development: High-specification starting material for developers targeting bioequivalent glycemic control therapeutics.
- Metabolic Syndrome Research: Utilized in scientific studies investigating DPP-4 inhibition kinetics and its cardiovascular safety profile.
Compliance & Quality Notice: This product is intended strictly for pharmaceutical formulation and industrial R&D. Not for direct human consumption. Store in tightly closed containers protected from light and moisture to ensure 24-month stability.
Frequently Asked Questions (FAQ)
Sitagliptin is a chiral molecule requiring high stereochemical control. Our synthesis process is optimized to ensure an enantiomeric excess (ee) of >99.5% for the (R)-isomer, complying with the strict safety and efficacy requirements of global pharmacopoeias.
How do you address potential genotoxic impurities in Sitagliptin manufacturing?
We strictly adhere to ICH M7 guidelines. Our manufacturing route is designed to minimize and validate the absence of potential genotoxic impurities (PGIs). Every batch undergoes rigorous HPLC and GC-MS screening to ensure compliance with international safety thresholds.
Does this API powder support the formulation of Sitagliptin Phosphate?
Yes. While this listing provides the Sitagliptin free base (CAS 486460-32-6), it is the direct precursor for salt formation. We can also provide the Sitagliptin Phosphate Monohydrate form (CAS 654671-77-9) depending on your formulation strategy for tablet stability and solubility.
What is the particle size distribution (PSD) of your Sitagliptin powder?
Particle size is critical for content uniformity in solid dosage forms. We offer standardized PSD (typically d90 < 100μm) and can provide micronized grades upon request to support the specific dissolution profiles required by your R&D team.
Does Xi'an Tihealth provide documentation for regulatory drug registration?
Yes. We provide a full technical documentation package, including the COA, MOA, Stability Data, and MSDS. Our quality team is ready to support your GMP audits and regulatory drug filings (CEP/DMF support) globally.
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