Iron (III) Hydroxide Polymaltose Complex

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Iron (III) Hydroxide Polymaltose Complex Specification

Loss on Drying
10.0%

Particle Size
90% < 50 microns

Taste
Characteristic, slightly sweet

Storage
Store below 25C, keep container tightly closed, protected from light

Smell
Odorless

Molecular Weight
Variable (polymeric complex)

Shelf Life
2 years

Heavy Metal (%)
0.002%

Molecular Formula
[FeO(OH)]nmC6H10O5

Melting Point
Decomposes

HS Code
30045090

Solubility
Soluble in water; forms a colloidal solution

Medicine Name
Iron (III) Hydroxide Polymaltose Complex

Type
Pharmaceutical Ingredient

Grade
Pharmaceutical Grade

Usage
Used in the treatment of iron deficiency anemia

Purity(%)
>98

Physical Form
Solid

About Iron (III) Hydroxide Polymaltose Complex

With our wide industry experience in the domain, we are engrossed in manufacturing and exporting high quality Iron (III) Hydroxide Polymaltose Complex. This product is iron supplement that helps in treating iron deficiency in body. Offered product is efficiently formulated using quality checked chemical substances under the proper guidance of our adroit professionals. Additionally, this Iron (III) Hydroxide Polymaltose Complex can be availed in varied packaging options as per the specific demands of the clients.

Features:

Effectiveness
Precise composition
Safe to use
Long shelf life

This is once again a strong member of our haematinic product range. The iron exists in ferric form, complexed with polymaltose. This is a non-ionic complex 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 it remains completely soluble in very wide range of pH .or one can state that the product remains soluble without giving turbidity in .1 N HCl solution also. The complex is stabilized in such a way that the polymaltose content is remains at its highest level. This ensures excellent stability and high absorption of iron from the formulation.

Our API can be comfortably used for liquid, tablets and capsules and Drops formulations.

Specifications:

Tests	Specifications
Description	Reddish deep brown coloured amorphous powder
Solubility	Soluble in 0.1M Hydrochloric acid and easily soluble in hot water
Identification
i) For Iron	To comply the identification test
ii) For Polymaltose	To comply the identification test
pH 5.0 % solution	Between 5.0 and 6.5
Absence of Oligomaltose & Oligoisomaltose	To be absent
Ionic Iron	To be absent
Water Content (By KF)	Not more than 7.0 % w/w
Sodium Chloride (on anhydrous basis)	Not more than 6.4 % w/w
Limit test	-
Arsenic	Not more than 2 ppm
Copper	Not more than 60 ppm
Lead	Not more than 25 ppm
Zinc	Not more than 150 ppm
Assay:
Elemental Iron (On as is basis)	Between 28.0 % to 40.0 %
Polymaltose (On Anhydrous basis)	Between 32.0 % to 50.0 %
Microbial Limit Test	-
Microbial Count	NMT 1000 cfu/gm
Yeast & Moulds	NMT 100 cfu/gm
Staphylococcus aureus	To be absent
Salmonellae	To be absent
E. Coli	To be absent
Pseudomonas aeruginosa	To be absent

Technical Details

Advanced Solution for Iron Deficiency

Iron (III) Hydroxide Polymaltose Complex is specifically designed for effective management of iron deficiency anemia. Its unique polymeric structure enables gradual and gentle release of iron, minimizing gastrointestinal side effects commonly seen with other iron supplements. This quality makes it a preferred ingredient in modern iron therapies.

Exceptional Pharmaceutical Grade Quality

Produced under rigorous quality controls, this complex boasts a purity greater than 98%, low heavy metal content (0.002%), and a fine particle size (90% < 50 microns). Its stability and colloidal solubility ensure compatibility with a variety of pharmaceutical formulations.

Safe and Long-lasting Storage

For optimal safety and efficacy, Iron (III) Hydroxide Polymaltose Complex should be stored in tightly sealed containers, below 25C, and protected from light. With these precautions, the product retains its properties for up to two years, providing manufacturers with a dependable inventory solution.

FAQs of Iron (III) Hydroxide Polymaltose Complex:

Q: How is Iron (III) Hydroxide Polymaltose Complex used in medicine?

A: Iron (III) Hydroxide Polymaltose Complex is primarily used as an active ingredient in formulations for the treatment of iron deficiency anemia. It enables controlled iron supplementation, contributing to the restoration of healthy hemoglobin levels.

Q: What are the benefits of using this complex over other iron supplements?

A: This complex offers a gradual and stable iron release profile, which helps to reduce typical gastrointestinal disturbances associated with iron therapy. Its high purity and pharmaceutical-grade quality ensure safety and efficacy in clinical applications.

Q: When should products containing this complex be considered for use?

A: Products made with Iron (III) Hydroxide Polymaltose Complex are typically recommended for individuals diagnosed with iron deficiency anemia or those with increased iron requirements due to medical conditions, pregnancy, or blood loss.

Q: Where is this pharmaceutical ingredient mainly exported or supplied from?

A: Iron (III) Hydroxide Polymaltose Complex is manufactured, exported, and supplied from India, adhering to global pharmaceutical standards for quality and safety.

Q: What is the recommended process for storing this pharmaceutical ingredient?

A: It should be stored below 25C in tightly closed containers, sheltered from light, to maintain its integrity and two-year shelf life.

Q: How soluble is Iron (III) Hydroxide Polymaltose Complex, and why is this important?

A: The complex is soluble in water, forming a colloidal solution. This property ensures uniform dispersion in pharmaceutical preparations, facilitating consistent dosing and effectiveness.

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