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Active Pharmaceutical Ingredient

Nicotine (CAS 54-11-5) API Manufacturer & Supplier in India

Also known as: Nicorette; Nicoderm; (-)-Nicotine

CAS: 54-11-5 Nicotinic Agonist / Smoking Cessation IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Nicotine API — Mediocon Inc
Nicotine — Pharmaceutical Grade API

Product Overview

CAS No: 54-11-5  |  MF: C₁₀H₁₄N₂  |  MW: 162.23 g/mol

Nicotine is a pharmaceutical-grade active ingredient classified as Nicotinic Agonist / Smoking Cessation. Mediocon Inc supplies high-purity Nicotine API conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Key Features

  • Dihydrofolate reductase inhibitor
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Rheumatoid arthritis
  • Psoriasis
  • Various cancers (ALL, NHL, osteosarcoma)

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameNicotine
Also Known AsNicorette; Nicoderm; (-)-Nicotine
CAS Number54-11-5
Chemical NameNicotine
Molecular FormulaC₁₀H₁₄N₂
Molecular Weight162.23 g/mol
CategoryNicotinic Agonist / Smoking Cessation
AppearanceOily liquid, colorless to pale yellow
SolubilityMiscible with water
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement

Sourcing, Regulatory & Export Information

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Nicotine (CAS 54-11-5) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Nicotine is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — before release with a Certificate of Analysis.

Export Markets

  • USA — FDA-registered facility; DMF support available for ANDA/NDA filings
  • Europe — EMA-compliant documentation; CEP/EDMF support on request
  • Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
  • Southeast Asia — established logistics network; temperature-controlled shipments
  • India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

  • ISO 9001:2015 certified quality management system
  • GMP-certified manufacturing facility, Aurangabad, Maharashtra
  • Full batch traceability from raw material to finished API
  • Stability data available (ICH Q1A guidelines) for regulatory submissions
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Nicotine API

What is the minimum order quantity for Nicotine API?
Mediocon Inc supplies Nicotine with a minimum order quantity of 1 kg (sample packs available for R&D). We accommodate both small R&D quantities and large commercial-scale orders. Contact our sales team at akshay@mediocon.com or +91 9309999757 for a tailored quote.
What pharmacopoeial grades of Nicotine does Mediocon supply?
We supply Nicotine conforming to IP / BP / EP / USP pharmacopoeial standards. Each batch is tested against full pharmacopoeial specifications and released with a Certificate of Analysis. Custom specifications can be accommodated for regulated markets.
What documentation is provided with Nicotine API?
Every shipment of Nicotine comes with: Certificate of Analysis (CoA), MSDS/SDS, Certificate of Origin (COO), and Drug Master File (DMF) support on request. We also provide GMP certification, ISO 9001:2015 compliance documentation, and full regulatory support for filings in USA (FDA), Europe (EMA), and other markets.
What is the lead time and shipping for Nicotine bulk orders?
Standard lead time for Nicotine is 2–4 weeks for standard orders; expedited shipments possible for urgent requirements. We ship to 40+ countries worldwide using approved pharmaceutical-grade packaging (25 kg HDPE drums / aluminium foil bags). All shipments include temperature-controlled logistics options where required by the product's storage conditions.

Request a Quote

Minimum Order: 1 kg (sample available)
Export to 40+ countries worldwide
Full documentation: CoA, MSDS, COO
Lead Time: 2–4 weeks (standard)
WhatsApp: +91 9309999757
akshay@mediocon.com
 Get Bulk Quote  Request CoA / MSDS

Quick Reference

CAS No54-11-5
FormulaC₁₀H₁₄N₂
MW162.23 g/mol
GradeIP / BP / EP / USP
CategoryNicotinic Agonist / Smoking Cessation

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