Active Pharmaceutical Ingredient

Sodium Chloride API Manufacturer & Supplier in India

Also known as: Salt; Table Salt; Saline; NaCl

CAS: 7647-14-5 Active Pharmaceutical & Food Ingredient IP / BP / EP / USP / FCC / NF GMP Certified Aurangabad, Maharashtra, India
Sodium Chloride API — Mediocon Inc
Sodium Chloride — Pharmaceutical Grade API

Product Overview

CAS No: 7647-14-5  |  MF: NaCl  |  MW: 58.44 g/mol

Sodium Chloride is an essential pharmaceutical and food-grade ingredient supplied by Mediocon Inc. Our high-purity Sodium Chloride conforms to IP / BP / EP / USP / FCC / NF specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Pharmaceutical-grade Sodium Chloride is used in intravenous saline solutions, ophthalmic preparations, nasal sprays, and as a tonicity agent in various formulations. It is also critical in dialysis solutions and wound irrigation.

Key Features

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

Applications

  • Intravenous saline infusion solutions
  • Ophthalmic and nasal pharmaceutical preparations
  • Tonicity-adjusting excipient
  • Dialysis and wound irrigation solutions

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 NameSodium Chloride
Also Known AsSalt; Table Salt; Saline; NaCl
CAS Number7647-14-5
Molecular FormulaNaCl
Molecular Weight58.44 g/mol
CategoryActive Pharmaceutical & Food Ingredient
AppearanceWhite crystalline powder or granules
SolubilityFreely soluble in water; slightly soluble in ethanol
GradeIP / BP / EP / USP / FCC / NF

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 Sodium Chloride (CAS 7647-14-5) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Sodium Chloride 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 — Sodium Chloride API

What is the minimum order quantity for Sodium Chloride API?
Mediocon Inc supplies Sodium Chloride 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 Sodium Chloride does Mediocon supply?
We supply Sodium Chloride conforming to IP / BP / EP / USP / FCC / NF 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 Sodium Chloride API?
Every shipment of Sodium Chloride 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 Sodium Chloride bulk orders?
Standard lead time for Sodium Chloride 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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