Nicotine

Nicotine (CAS: 54-11-5)

GMP-Grade API for NRT and QC Applications

Nicotine (3‑[(2S)‑1‑methylpyrrolidin‑2‑yl]pyridine) is a plant-derived alkaloid and the core API used in nicotine replacement therapies (NRT) such as gums, patches, lozenges, and inhalation products. Our offering includes high-purity, pharmaceutical-grade Nicotine, available in both standard and customized bulk quantities with full regulatory documentation.

Backed by stringent manufacturing standards, Pharmint provides nicotine conforming to global pharmacopeial monographs—USP, EP, JP—ensuring consistency, safety, and audit-readiness across regulated markets.

Where is Nicotine Used in Pharma and R&D?

✔ Nicotine Replacement Therapy (NRT)

Pharmint supplies nicotine in GMP-grade quality, designed for therapeutic use in smoking cessation products such as:

• Nicotine patches (transdermal systems)
• Chewing gums and oral strips
• Nasal sprays and inhalers

✔ Analytical Method Development & Quality Control

We also supply analytical-grade (S)-Nicotine suitable for:

• Chromatographic method validation
• Stability testing
• Internal standard use in regulatory submissions

✔ R&D and Custom Formulations

For laboratories and CDMOs developing novel NRT delivery systems, we offer custom packaging, small-batch lots, and R&D documentation support.

Technical Specifications

Why Source Nicotine from Pharmint? 

✅ Full Regulatory Support

We understand the rigorous documentation needs of regulated markets. Each nicotine batch is shipped with:

• GMP Certificate
• CoA (Certificate of Analysis)
• USDMF & CEP support
• ICH Stability Data (on request)

✅ Global Fulfillment & Compliance

• Export-ready with end-use declaration support
• Hazardous Goods shipping protocol (Class 6.1)
• Dedicated regulatory liaison for CEP/DMF access

✅ Flexible Supply Chain for Pharma Procurement

• MOQ starts from grams to multi-kilo bulk
• Cold-chain and compliance shipping
• White-label options for formulation partners

✅ Trusted Manufacturing Provenance

Sourced from GMP-audited production sites with CEP/USDMF linkage—used by top NRT brands and formulation CDMOs across the U.S., EU, and Asia-Pacific.

How Is Nicotine Packaged and Stored?

• Supplied in HDPE/Amber glass with PTFE-lined closures
• Long-term storage: 15–30 °C, protected from light
• Analytical standards available in 1 mg/mL methanol solution with full SDS and TDS

Is This Nicotine Suitable for International Export?

Yes. Pharmint ensures:

• Global export-readiness, with support for end-use declarations
• Hazardous goods shipping compliance (UN1992, Class 6.1)
• Labeling in line with GHS/REACH/CLP

Who Uses Pharmint’s Nicotine?

Our nicotine is trusted by:

• Global NRT brands for finished dosage formulation
• CDMOs for formulation and ANDA filings
• Analytical labs validating pharmacopeial methods

Nicotine FAQs

Can nicotine from Pharmint be used in regulated NRT products?

Yes. Our nicotine meets GMP, USP, and EP standards, with CoA and full regulatory files (USDMF, CEP) to support registration in the U.S., EU, and Japan.

What grade of nicotine is offered for QC and method development?

We offer (S)-Nicotine as a certified reference standard (≥99%) in both neat and methanolic solutions, with traceable purity, COA, and stability data.

What regulatory documentation is included with bulk nicotine supply?

We provide GMP Certificate, CoA, MSDS, and optional USDMF/CEP access, tailored to the compliance needs of each buyer’s market.

Is this product REACH-registered or compliant for EU distribution?

Our nicotine is compliant with REACH and CLP regulations, and can be shipped within the EU with appropriate safety labeling and transport classification.

What is the standard lead time and MOQ for pharmaceutical nicotine?

Typical lead time is 7–14 days ex-stock; MOQ begins at 50 grams for R&D and 1 kg for commercial NRT manufacturing, with scalable volume pricing.