Active Pharmaceutical Ingredient

Nimustine API Manufacturer & Supplier

CAS: 42471-28-3 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Nimustine API Manufacturer & Supplier — Mediocon Inc
Nimustine API Manufacturer & Supplier

Product Overview

CAS No: 42471-28-3 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

Nimustine API Manufacturer & Supplier

MEDIOCON INC is a trusted global manufacturer and supplier of Nimustine API, offering premium-quality pharmaceutical-grade active pharmaceutical ingredients for pharmaceutical manufacturing, oncology formulation development, analytical testing, quality control, stability studies, and research applications. Every batch is manufactured under stringent quality management systems to ensure superior purity, consistency, and compliance with international pharmaceutical standards.

Nimustine is a nitrosourea-class alkylating antineoplastic agent widely used in oncology pharmaceutical research and formulation development. It exerts its therapeutic activity by alkylating DNA, thereby inhibiting DNA replication and cell proliferation. Nimustine has been extensively studied for the treatment of malignant brain tumors, leukemia, lymphoma, and other solid tumors. It is also utilized in pharmaceutical process development, analytical method validation, stability studies, and quality assurance programs.

MEDIOCON INC supplies premium-quality Nimustine API to pharmaceutical manufacturers, oncology research organizations, contract research organizations (CROs), formulation development companies, universities, and analytical laboratories worldwide. Complete documentation, including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and regulatory support documents, is available upon request.

Product Specifications

Product NameNimustine API Manufacturer & Supplier
CAS Number42471-28-3
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceWhite to Off-White Crystalline Powder
StandardsPharmaceutical Specifications

Analytical Specifications

ParameterSpecification
AppearanceWhite to Off-White Crystalline Powder
IdentificationIR, UV & HPLC Compliant
Assay (HPLC)98.0% – 102.0%
Loss on DryingNMT 1.00%
Residue on IgnitionNMT 0.20%
Heavy MetalsNMT 10 ppm
pH (1% Solution)4.0 – 6.0
Individual ImpurityNMT 0.50%
Total ImpuritiesNMT 1.50%
Water ContentNMT 1.00%
Melting Point205°C – 210°C
SolubilityFreely soluble in water; slightly soluble in methanol

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 Nimustine API Manufacturer & Supplier (CAS 42471-28-3) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Nimustine API Manufacturer & Supplier 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 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
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Nimustine API Manufacturer & Supplier

What is Nimustine API?
Nimustine API is a nitrosourea alkylating antineoplastic agent used in oncology pharmaceutical formulations and cancer research.
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