Product Introduction
Product Information
|
Item |
Specification |
|
Product Name |
Empagliflozin Powder |
|
API Name |
Empagliflozin API |
|
CAS Number |
864070-44-0 |
|
Molecular Formula |
C23H27ClO7 |
|
Molecular Weight |
450.91 |
|
Appearance |
White to off-white crystalline powder |
|
Assay (HPLC) |
≥99.0% |
|
Loss on Drying |
≤1.0% |
|
Residual Solvents |
Complies with ICH guidelines |
|
Heavy Metals |
≤10 ppm |
|
Particle Size |
Customizable |
|
Storage Conditions |
Cool, dry, well-ventilated area |
|
Shelf Life |
24–36 months (sealed) |
Functions and Applications
Empagliflozin Powder (CAS 864070-44-0) functions through a unique and well-characterized mechanism of action. As a highly selective SGLT2 inhibitor, it modulates renal glucose reabsorption. This primary function enables its incorporation into various advanced health management formulations.
1 Primary Functional Application:
- Metabolic Support Formulations: The core application of Empagliflozin API is in the manufacture of solid oral dosage forms (primarily tablets and fixed-dose combinations) designed to support systemic glucose metabolism. By facilitating the excretion of excess glucose via urine, it aids in the maintenance of healthy plasma glucose levels. This mechanism is independent of insulin secretion, making it a valuable component in comprehensive metabolic health strategies.
2 Research and Development Applications:
- Novel Drug Delivery Systems (NDDS): Researchers utilize high-purity Empagliflozin Powder to develop innovative delivery platforms, such as sustained-release matrices, nano-formulations, and transdermal systems, aiming to improve bioavailability and patient compliance.
- Fixed-Dose Combination (FDC) Development: Its complementary mechanism makes it an ideal candidate for FDC development with other supportive agents, offering potential synergistic benefits in multifaceted health management approaches.
- Mechanistic and Pharmacological Studies: Academic and institutional researchers source our API for in vitro and in vivo studies to further elucidate its pharmacodynamics, pharmacokinetics, and potential new avenues of application.
Key Advantages for Manufacturers
High Bioavailability
The intrinsic properties of the molecule support effective formulation into oral solid doses with consistent dissolution profiles.
Chemical Stability
When stored under recommended conditions, Empagliflozin Powder demonstrates excellent long-term stability, a critical factor for product shelf-life.
Established Safety Profile
The pharmacological profile is extensively documented in global scientific literature, providing a strong foundation for formulation development.
Frequently Asked Questions (FAQ)
Q1: What is your quality assurance system for Empagliflozin Powder?
A1: Our manufacturing strictly adheres to GMP guidelines. Every batch undergoes full QC testing per our rigorous specifications. We provide a comprehensive Certificate of Analysis (COA), and supporting documentation (including stability data and MSDS) is available upon request. Third-party lab verification can be accommodated.
Q2: Can you supply Empagliflozin API that complies with various pharmacopoeias (USP, EP, etc.)?
A2: Yes. Our standard Empagliflozin API (CAS 864070-44-0) is manufactured to meet or exceed the major pharmacopoeial standards, including USP and EP monographs. Please specify your required compliance standard when requesting a quote.
Q3: What is the minimum order quantity (MOQ), and can you provide samples for R&D?
A3: Our standard MOQ is 1 kg. We are happy to provide evaluation samples (typically 10-25g) for qualified clients engaged in legitimate R&D and formulation work. A nominal fee may apply to cover handling and shipping.
Q4: How do you ensure supply chain stability and confidentiality?
A4: We maintain strategic inventory of key starting materials and finished API. Our supply chains are audited and diversified for resilience. All client information, project details, and formulations are protected under strict non-disclosure agreements (NDAs), which we are prepared to sign at the outset of our dialogue.
Q5: What technical support do you offer?
A5: Beyond providing the high-quality Empagliflozin Powder, we offer extensive technical support. This includes access to regulatory documentation, formulation consultation (at a high level), and stability data packages.
Q6: What are the payment and shipping terms?
A6: We offer flexible international trade terms (common Incoterms: EXW, FOB, CIF, DAP). All shipments are processed with professional, discreet labeling and full commercial and regulatory documentation to ensure smooth customs clearance worldwide.
TNJONE Products are designed for research and industrial use only. Not intended for clinical or medical purposes.
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