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Iron Iii Hydroxide Polymaltose API

Name of Product Iron Iii Hydroxide Polymaltose
CAS No 53858-86-9
Therapeutic use:- Iron Salts
Grade BP/USP
Form:- API Powder
Status Commercial

Product Overview

Iron (III) Hydroxide Polymaltose API is a reddish-brown powder that dissolves in water. It is used for developing both solid and liquid formulations. The API is made with strict quality standards. This meets bulk supply needs in regulated and semi-regulated markets.

Therapeutic Applications

Iron (III) Hydroxide Polymaltose API is used to make iron-based oral and liquid medicines. It supports various formulations, including tablets, capsules, and syrups. The API is great for formulation research. It meets the quality standards needed for stable processing.

Specification Parameters

For Iron (III) Hydroxide Polymaltose API, here are the key things to focus on to ensure quality and control:

  • Chemical Name (IUPAC):– Iron(III) hydroxide–polymaltose complex

  • CAS Number:- 53858-86-9

  • Molecular Formula:– (FeO(OH))n · mC6H10O5

  • Molecular Weight:– Variable, polymeric complex

  • Appearance:– Reddish-brown to dark brown amorphous powder

  • Odour:– Odourless

  • Solubility:- Soluble in water; forms a colloidal solution.

  • Identification Tests:- Iron reaction test and Carbohydrate reaction test

  • Assay Method: HPLC or a validated method for determining elemental iron.

  • Assay Specification: Iron content must be within the defined API limits.

  • Related Substances / Impurities: Controlled; limit free ionic iron.

  • Residual Solvents: Complies with ICH Q3C requirements

  • Elemental Impurities (ICH Q3D): Controlled for As, Pb, Cd, and Hg

  • Loss on Drying / Water Content: Within the specified percentage limit.

  • pH (Aqueous Solution): Within the controlled API range

  • Microbial Limits: Within limits.

Packaging & Storage

Store Iron (III) Hydroxide Polymaltose API in a cool, dry place, away from light and moisture. The API is available in HDPE or fiber drums containing up to 25 kg of the product. The API should be stored at a temperature below or equal to 25°C. The API should also be stored away from strong chemicals.

Why Choose Us

Actiza Pharma offers a reliable API for iron (III) hydroxide polymaltose. We maintain strict quality control with advanced facilities and expert teams.

  • Quality Assurance

At our facility, we follow WHO-GMP and ISO standards. This means every API batch undergoes strict quality checks and safety norms. We ensure consistency at every stage.

  • Advanced Facilities

Our modern plants use automation. We have controlled areas, clean spaces, and special tools. This helps us produce APIs that are pure, stable, and consistent

  • Strong Integration

We handle raw materials, processes, and timelines using our API manufacturing and supply control. This helps us ensure a steady supply, manage costs, and keep API performance reliable.

  • Customer Commitment

We provide flexible order sizes and timely delivery. We communicate clearly and offer global support. This helps partners easily source Iron (III) Hydroxide Polymaltose API