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Iron Hydroxide Polymaltose Complex

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MOQ : 1 Ton

Iron Hydroxide Polymaltose Complex Specification

Taste
Slightly sweet

Shelf Life
36 months

Ph Level
5.0-7.5 (1% solution)

Molecular Formula
[C12H22O11nFeO(OH)]

Loss on Drying
5.0%

Solubility
Freely soluble in water

Color
Dark brown to reddish brown

Particle Size
90% < 100 m

Poisonous
Non-toxic at therapeutic doses

Structural Formula
-

Melting Point
Not applicable (decomposes on heating)

Storage
Store in cool, dry place, protect from light

HS Code
30039011

Heavy Metal (%)
0.001%

EINECS No
-

Molecular Weight
Approximately 50,000 Da (variable, polymeric)

Smell
Odorless

Medicine Name
Iron Hydroxide Polymaltose Complex

Chemical Name
Iron(III)-Hydroxide Polymaltose Complex

CAS No
9004-66-4

Type
Pharmaceutical Raw Material

Grade
Pharmaceutical Grade

Usage
Used as iron supplement for treatment of iron deficiency anemia

Purity(%)
98%

Appearance
Dark brown to reddish brown amorphous powder

Physical Form
Powder

Residual Solvent
Complies with ICH Q3C

Reducing Sugar
3.0%

Identification
Positive for both iron and polymaltose

Arsenic Content
2 ppm

Packaging
Double PE bag in fiber drum

Chloride Content
0.2%

Iron Content
20.0%-25.0%

Bacterial Endotoxins
<0.5 EU/mg

Microbial Limits
Total aerobic microbial count 1000 CFU/g, absence of Escherichia coli & Salmonella

Bulk Density
0.5-0.7 g/cm3

Regulatory Compliance
USP/EP/IP/BP

About Iron Hydroxide Polymaltose Complex

Iron Hydroxide polymaltose complex.
This is once again a strong member of our haematinic product range. It supplies iron in ferric form complexed with polymaltose. This is a non ionic molecule and charge of iron is completely shielded. This ensures maximum absorption in the body.

The speciality of this product is iron is completely hydrolysed and thus it remains completely soluble in stomach pH or one can state that the product gives clear blood red solution without turbidity in .1 N HCl solution. The complex is made in such a way that the polymaltose content remains at its highest level. This ensures excellent stability and high absorption of iron .

our product is reddish brown to dark brown amorphous powder and can be comfortably used for liquid,tablets and capsules formulations.

Technical Details

Reliable Iron Supplement for Anemia Treatment

Iron Hydroxide Polymaltose Complex is designed as a safe and effective iron supplement for both adults and children suffering from iron deficiency anemia. Its high purity and pharmaceutical quality guarantee optimal iron absorption while minimizing gastrointestinal irritation. Manufactured in India, it adheres to global regulatory standards to ensure maximum efficacy and safety.

Stringent Quality and Safety Standards

This product is rigorously tested to comply with limits for microbial content, heavy metals, arsenic, chloride, and bacterial endotoxins. Absence of pathogens such as Escherichia coli and Salmonella supports its suitability for pharmaceutical use. The bulk density and particle size distribution ensure easy formulation and integration into various dosage forms.

FAQ's of Iron Hydroxide Polymaltose Complex:

Q: How is Iron Hydroxide Polymaltose Complex administered in pharmaceutical applications?

A: Iron Hydroxide Polymaltose Complex is formulated as an active ingredient in tablets and syrups, intended for oral consumption to treat iron deficiency anemia. Its excellent solubility in water enables easy incorporation into liquid formulations.

Q: What are the main benefits of using Iron Hydroxide Polymaltose Complex for iron supplementation?

A: This complex provides a stable and bioavailable source of iron, leading to better absorption and reduced gastrointestinal side effects compared to other iron salts. Its non-toxic nature at therapeutic dosages further enhances patient safety.

Q: When should Iron Hydroxide Polymaltose Complex be used?

A: It should be used when there is a clinical diagnosis of iron deficiency anemia, typically indicated by symptoms such as fatigue, weakness, or laboratory findings. As a pharmaceutical raw material, formulations containing this complex are prescribed by healthcare professionals.

Q: Where should Iron Hydroxide Polymaltose Complex be stored to maintain its quality?

A: To ensure product stability and prevent degradation, it should be stored in a cool, dry place and protected from light. Proper packaging in double PE bags within fiber drums further safeguards against moisture and contamination.

Q: What processes ensure the safety and compliance of this product?

A: The product undergoes comprehensive testing for microbial limits, endotoxins, residual solvents, and heavy metals, complying with international standards such as USP, EP, IP, and BP. This guarantees safety for pharmaceutical use.

Q: How does Iron Hydroxide Polymaltose Complex benefit manufacturers and exporters?

A: With its high purity, regulatory compliance, and reliable supply from India, it offers manufacturers a consistent and safe iron supplement ingredient suitable for global markets, facilitating product registration and distribution.

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