Empagliflozin API FAQs: Storage, Solubility, COA, and Manufacturing Standards

Empagliflozin API FAQs: Storage, Solubility, COA, and Manufacturing Standards

Empagliflozin API is a critical compound used in the formulation of anti-diabetic drugs (SGLT2 inhibitors) and is widely procured by pharmaceutical companies for global markets. This guide answers the 9 most frequently asked questions about its storage, solubility, shelf life, COA, and manufacturing standards. With India, particularly Hyderabad, emerging as a leading API export hub, and Bio-Synth being a WHO-GMP-compliant manufacturer located in the Balanagar Industrial Area, this article will help B2B buyers and scientists make informed sourcing decisions.

 

What Is Empagliflozin API and Why Does It Matter?

A Potent SGLT2 Inhibitor API for Diabetes Management

Empagliflozin API Specification is a selective sodium-glucose co-transporter 2 (SGLT2) inhibitor. Its active form, Empagliflozin API, is used in oral anti-diabetic medications to control blood sugar levels in patients with type 2 diabetes. It helps eliminate excess glucose through the urine.

Many branded formulations (e.g., Jardiance®) rely on high-purity Empagliflozin API Manufacturers in India. Due to its growing demand, global procurement teams actively seek reliable suppliers of Empagliflozin API in India for cost-effective, quality-assured sourcing.

 

Top 9 FAQs About Empagliflozin API (Storage, Stability, Solubility, and More)

 

1. What is the ideal storage condition for Empagliflozin API?

Empagliflozin API should be stored:

• In airtight containers 
• Protected from light, moisture, and oxygen 

Cold chain logistics are not necessary, but long-term exposure to ambient humidity can degrade potency.

Storage Summary Table:

Parameter	Requirement
Moisture Control	Desiccated environment
Light Sensitivity	Opaque/amber packaging
Packaging Material	HDPE or inert glass containers

 

2. What is its solubility profile?

Empagliflozin is practically insoluble in water but soluble in:

• Dimethyl sulfoxide (DMSO) 
• Methanol 
• Acetonitrile 

For formulation R&D, the use of co-solvents or nanoparticle engineering (e.g., spray drying) improves its bioavailability.

 

3. How long is its shelf life under standard storage?

Under sealed, optimal conditions, Empagliflozin API Suppliers confirm:

• Shelf life of up to 36 months 
• Confirmed through real-time and accelerated stability data 

WHO-GMP guidelines require validated stability testing with ICH-compliant protocols.

 

4. What information does the Certificate of Analysis (COA) include?

A valid COA from GMP-certified facilities like Bio-Synth outlines:

• Identification via IR and HPLC 
• Assay value (typically ≥ 98.5%) 
• Residual solvent analysis (GC) 
• Heavy metal limits 
• Microbial contamination (Total Plate Count) 
• Loss on drying (LOD) 
• Particle size distribution (PSD) 

Each batch follows validated analytical methods as per pharmacopeial standards (USP, Ph. Eur. or in-house).

 

🔍 Explore Bio-Synth’s API catalog for high-purity, GMP-compliant pharmaceutical ingredients.

 

5. Is Empagliflozin API covered by patents?

Yes. However:

• Original compound patent expired in most geographies (US: 2025) 
• API can be manufactured generically, where no valid patent applies 
• FTO (Freedom to Operate) analysis is essential for export compliance 

Companies sourcing from India must ensure that Empagliflozin API Manufacturers provide:

• FTO documentation 
• Non-infringement certificates (especially for US/EU markets) 

 

6. What are the key quality standards followed in API production?

High-quality Empagliflozin API Manufacturers in India must meet:

• WHO-GMP & EU-GMP compliance 
• ICH Q7 and Q11 standards for APIs 
• ALCOA+ principles for data integrity 

Bio-Synth’s Hyderabad plant includes in-house QC labs with UPLC, GC-MS, and TGA to ensure every batch conforms to specifications.

 

7. How is it packaged for international shipment?

Empagliflozin API Suppliers in India typically ship in:

• HDPE containers with double-layered liners 
• Nitrogen flushing if required 
• Clearly labeled with batch number, manufacturing & expiry date 

Each shipment includes full regulatory documentation: COA, MSDS, stability data, and COPP (if applicable).

 

8. How can global procurement teams source Empagliflozin API from India?

Pharma procurement teams can follow this sourcing framework:

1. Identify WHO-GMP Empagliflozin API Suppliers via online catalogs or trade directories 
2. Request tech pack and sample COA 
3. Verify audit certifications (WHO-GMP, EU-GMP) 
4. Obtain quotations with Incoterms 
5. Conduct Vendor Qualification/On-site audit (if required) 
6. Agree on PKI/DMF registration if for regulated markets 

 

Why Indian API Manufacturers Like Bio-Synth Are Trusted Worldwide

India supplies over 20% of the global demand for generic APIs. Facilities in Hyderabad and across Telangana have decades of process chemistry expertise.

Bio-Synth, in particular, offers:

• Over 75 years of API manufacturing legacy 
• GMP-certified plants and zero deviation regulatory audits 
• A dedicated R&D wing for SAPIs and anti-diabetics 
• Consistent COA-backed batch quality 
• Proven partners in Europe, MENA, and SE Asia 

 

📩 Contact Bio-Synth today for bulk quotes, regulatory documentation, and CDMO collaboration.

 

FAQs

Why do buyers trust Indian API suppliers like Bio-Synth?

India offers large-scale, cost-effective API manufacturing under WHO-GMP and USFDA-compliant conditions. Bio-Synth in Hyderabad ensures quality, traceability, and regulatory adherence.

What should I check in a COA before accepting shipment?

Key factors to verify:

• Assay (≥98.5%) 
• Heavy metal profile 
• Residual solvents 
• Particle size (D90) 
• Stability data 

Can I buy Empagliflozin API online?

Not directly in retail. Authorized buying from Empagliflozin API Suppliers in India, like Bio-Synth involves documentation, legal checks, and regulated commerce.

 

Final Thoughts

Empagliflozin API remains in high demand due to rising global diabetes cases. For pharmaceutical companies formulating anti-diabetic tablets or looking for a reliable CDMO partner, sourcing from certified Indian manufacturers is strategic and cost-effective.

With a WHO-GMP approved facility in Hyderabad’s industrial heartland, Bio-Synth ensures dependability in quality, delivery, and compliance making it the preferred partner for Empagliflozin API Price in India and beyond.