Active Pharmaceutical Ingredient

Nimustine Hydrochloride API Manufacturer & Supplier

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

Product Overview

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

Nimustine Hydrochloride API Manufacturer & Supplier

MEDIOCON INC is a trusted global manufacturer and supplier of Nimustine Hydrochloride 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 systems to ensure exceptional purity, consistency, and compliance with international pharmaceutical standards.

Nimustine Hydrochloride is a nitrosourea-based alkylating antineoplastic agent widely used in oncology pharmaceutical research and formulation development. It works by alkylating DNA, resulting in inhibition of DNA replication and cell division, making it effective in the treatment of various malignant tumors. Nimustine Hydrochloride has been extensively studied for brain tumors, malignant lymphoma, leukemia, and other solid tumors. It is also widely utilized in pharmaceutical process development, analytical method validation, stability studies, and quality assurance programs.

MEDIOCON INC supplies high-quality Nimustine Hydrochloride API to pharmaceutical manufacturers, oncology formulation companies, contract research organizations (CROs), universities, research institutes, and analytical laboratories worldwide. Comprehensive documentation including COA, MSDS, Technical Data Sheet (TDS), and other regulatory support documents is available upon request.

Product Specifications

Product NameNimustine Hydrochloride 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 Hydrochloride 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 Hydrochloride 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 Hydrochloride API Manufacturer & Supplier

What is Nimustine Hydrochloride API?
Nimustine Hydrochloride API is a nitrosourea alkylating antineoplastic agent used in oncology pharmaceutical formulations and cancer research. Q2. What is Nimustine Hydrochloride used for?
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