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Nitrofurantoin Monohydrate/Macrocrystals API

Name of Product Nitrofurantoin Monohydrate/Macrocrystals API
CAS No 17140‑81‑7
Therapeutic use:- Antidiabetic
Grade USP/BP/EP/IP
Status Commercial
Form:- API Powder
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Product Overview

Nitrofurantoin Monohydrate, Nitrofurantoin Anhydrous, and Nitrofurantoin Macrocrystals are three different raw forms of the same medication.

They are of the same active pharmaceutical ingredient but not the same.

They differ in hydration state or particle size, but the chemical structure remains the same.

Each of them also functions slightly differently in the body.

It is subsequently used to make capsules, tablets, and suspensions.

The three vary from each other in the way they dissolve.

They also vary in the way they are absorbed and the way they release the medicine.

  • Nitrofurantoin Monohydrate: Releases the medicine slowly within the stomach and intestines. This helps in achieving even levels within the body.

  • Nitrofurantoin Anhydrous: Dissolves rapidly and acts rapidly once consumed.

  • Nitrofurantoin Macrocrystals: Have larger particles. Macrocrystals are designed to reduce gastrointestinal discomfort due to their slower dissolution.

    Therapeutic Applications

    Nitrofurantoin is a well-established active pharmaceutical ingredient (API).

    It is mainly utilized in the manufacturing of drugs for urinary tract infection (UTI).

    It also works effectively at low doses. It even has low bacterial resistance even after years of use.

    Pharmaceutical firms use it in the production of drugs for simple lower UTIs.

    It is used to develop drugs that protect against recurrence.

    This benefits people who are prone to them repeatedly.

    Nitrofurantoin comes in three forms: Monohydrate, Anhydrous, and Macrocrystals.

    They have various characteristics. They can formulate drugs that are safe to take, strong, and easy to take.

    Specification Parameters

    • Appearance: Yellow crystalline powder

    • Molecular Formula: C8H6N4O5

    • Molecular Weight: 238.16 g/mol

    • Solubility: Weakly soluble in water. More soluble in anhydrous form. Less soluble in macrocrystals.

    • Melting Point: About 268 °C (decomposes at this temperature).

    • Identification Tests: Determined by infrared (IR) spectroscopy and high-performance liquid chromatography (HPLC).

    • Assay (Purity): Not less than 98% on a dried basis.

    • Loss on Drying: Differing depending on the form. Monohydrate contains water molecules. Anhydrous contains very few.

    • Related Substances: Needs to be below safety levels. Impurities need to be low.

    • Microbial Limits: Must undergo strict tests to confirm that there are no toxic microbes.

      Packaging & Storage

      Primary Packaging Forms:

      • Double-lined polyethylene pouches for moisture protection

      • High-density polyethylene (HDPE) drums for durability

      • Barrier-lined fiber drums for additional protection

        Popular Pack Sizes:

        • 25 kg

        • 50 kg

        • Special sizes on request from customers

          Storage Requirements:

          • Keep in a dry and cool place

          • Keep away from direct sunlight and moisture

          • Keep at temperatures not more than 25 °C

          • Close the containers tightly after each use

            Why Choose Us

            Actiza Pharmaceutical Pvt. Ltd, make sure to produce and deliver APIs that meet international standards. We serve customers worldwide.

            • We are USP, BP, and EP compliant. Drug Master Files (DMFs) and documentation are available.

            • Our factories comply with the newest Good Manufacturing Practice (cGMP).

            • We have a strong supply chain that serves companies worldwide.

            • Package options are designed to protect stability. They can be customized, too.

            • Every batch is screened with the use of HPLC, IR, and microbial tests.

            • Our staff offers technical assistance, clear communication, and timely delivery.