Active Pharmaceutical Ingredient

Streptozotocin API Manufacturer & Supplier in India

Also known as: STZ; Streptozocin; Zanosar

CAS: 18883-66-4 Antineoplastic / Cytotoxic Antibiotic IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Streptozotocin API — Mediocon Inc, Aurangabad Maharashtra India
Streptozotocin — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 18883-66-4  |  MF: C₈H₁₅N₃O₇  |  MW: 265.22 g/mol

Streptozotocin is a naturally occurring nitrosourea cytotoxic antibiotic used primarily for treatment of metastatic islet cell carcinoma of the pancreas. Mediocon Inc supplies pharmaceutical-grade Streptozotocin conforming to IP / BP / EP / USP specifications.

It selectively destroys insulin-producing beta cells of the pancreas and is widely used as a research tool to induce diabetes in animal models. It also has antineoplastic properties used in oncology.

Key Features

  • High-purity pharmaceutical grade API
  • IP / BP / EP / USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing facility

Applications

  • Pancreatic islet cell carcinoma treatment
  • Diabetes research models
  • Oncology formulations
  • Cytotoxic drug R&D

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 NameStreptozotocin
Also Known AsSTZ; Streptozocin; Zanosar
CAS Number18883-66-4
Molecular FormulaC₈H₁₅N₃O₇
Molecular Weight265.22 g/mol
CategoryAntineoplastic / Cytotoxic Antibiotic
AppearancePale yellow to yellowish crystalline powder
SolubilitySoluble in water, DMSO, and alcohols
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
Mfg DateMAR 2025
Exp DateFEB 2031
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 Streptozotocin (CAS 18883-66-4) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Streptozotocin 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 — Streptozotocin API

What is the minimum order quantity for Streptozotocin API?
Mediocon Inc supplies Streptozotocin 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 Streptozotocin does Mediocon supply?
We supply Streptozotocin 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 Streptozotocin API?
Every shipment of Streptozotocin 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 Streptozotocin bulk orders?
Standard lead time for Streptozotocin 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.
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