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HYDROXYUREA IP/USP

Name: HYDROXYUREA IP/USP
Brand: IPSUM LIFESCIENCES LLP
Price: 619.0 INR
Availability: InStock

Price 619.0 INR/ Kilograms

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MOQ : 25 Kilograms

HYDROXYUREA IP/USP Specification

Boiling point
Decomposes

Loss on Drying
0.5% max

Melting Point
132-135C

Storage
Store in a cool, dry place, protected from light

EINECS No
204-737-9

Assay
>=99% (on dried basis)

Place of Origin
India

Residue on Ignition
0.1% max

Moisture (%)
0.5% max

HS Code
29241900

Particle Size
NMT 150 microns

Ph Level
5.5-7.0 (10% solution)

Heavy Metal (%)
0.001% max

Molecular Formula
CH4N2O2

Molecular Weight
76.05 g/mol

Other Names
Hydroxycarbamide, Hydroxyurea IP, Hydroxyurea USP

CAS No
127-07-1

Type
Pharmaceutical Raw Material

Grade
Pharmaceutical Grade

Usage
Antineoplastic Agent, Sickle Cell Anemia Therapy, Cancer Treatment

Purity
>=99%

Appearance
Crystalline Powder

Application
Used in the manufacture of formulations for sickle cell disease, certain cancers, and as a laboratory reagent

Raw Material
API for Hydroxyurea formulations

Smell
Odorless

Color
White

Form
Solid

Origin of Raw Material
Plant/chemical synthesis

Shelf Life
36 months from date of manufacture

Packaging
Available in 1 kg, 5 kg, 25 kg, and 50 kg HDPE drums with inner liners

Residual Solvents
Complies with ICH Q3C guidelines

Certificate of Analysis
Available with every batch

Identification
Complies with standard IP/USP tests

Solubility
Freely soluble in water, slightly soluble in alcohol, practically insoluble in ether

Endotoxin Level
Not more than 0.25 EU/mg

Microbial Limits
Total aerobic microbial count NMT 1000 cfu/g, total yeast & mold count NMT 100 cfu/g

About HYDROXYUREA IP/USP

Hydroxyurea, as specified by both the Indian Pharmacopoeia (IP) and United States Pharmacopeia (USP), is a pharmaceutical compound that serves as an essential therapeutic agent in the treatment of various conditions. It is primarily known for its use in oncology and hematology.

Versatile Therapeutic Applications

Hydroxyurea IP/USP is widely utilized in the development of oral formulations for sickle cell anemia and various cancers, owing to its reliable efficacy as an antineoplastic agent. Its utility as a laboratory reagent and in chemical research further extends its importance in medical and scientific fields. The compound's plant or chemical synthesis origin guarantees consistent quality and traceability.

Stringent Quality and Compliance

Every batch of Hydroxyurea IP/USP undergoes comprehensive testing to comply with IP/USP standards, with certificates of analysis provided. It meets benchmarks for residual solvents (ICH Q3C), endotoxin level (0.25 EU/mg), and microbial contamination, ensuring pharmaceutical-grade quality. Precise particle size (150 microns) and tightly controlled impurities support consistent formulation performance.

Robust Packaging and Shelf Stability

The product is available in 1 kg, 5 kg, 25 kg, and 50 kg HDPE drums with inner liners, securing the substance from moisture and light. Manufacturers and suppliers can rely on its 36-month shelf life from the date of manufacture when stored in a cool, dry place. This careful packaging ensures product stability and integrity throughout its usage period.

FAQ's of HYDROXYUREA IP/USP:

Q: How should Hydroxyurea IP/USP be stored to maintain its quality over time?

A: Hydroxyurea IP/USP should be stored in a cool, dry place, protected from light, to preserve its potency and shelf life of 36 months. Always keep the packaging sealed when not in use.

Q: What are the main pharmaceutical applications of Hydroxyurea IP/USP?

A: Hydroxyurea IP/USP is primarily used in the formulation of medications for sickle cell disease, certain cancers, and serves as a laboratory reagent due to its high purity and reliability.

Q: Where is Hydroxyurea IP/USP manufactured, and what quality certifications are provided?

A: This product is manufactured in India by certified suppliers. Each batch comes with a Certificate of Analysis, confirming compliance with IP/USP standards and ICH Q3C guidelines for pharmaceutical applications.

Q: What identification and quality tests does Hydroxyurea IP/USP undergo during production?

A: Hydroxyurea IP/USP passes standard IP/USP identification tests and undergoes detailed analysis for purity, microbial limits, residual solvents, particle size, and endotoxin levels, ensuring pharmaceutical-grade quality.

Q: What is the process behind sourcing raw materials for Hydroxyurea IP/USP?

A: The raw material for Hydroxyurea IP/USP is sourced via plant-based or chemical synthesis methods, both of which are controlled to ensure consistent supply and traceability.

Q: When is Hydroxyurea IP/USP ready for shipment, and how is it packaged?

A: Once manufacturing and testing are complete, Hydroxyurea IP/USP is packed in HDPE drums (1, 5, 25, or 50 kg) with inner liners, and is ready for prompt shipping to manufacturers, suppliers, and traders.

Q: What are the main benefits of using Hydroxyurea IP/USP in pharmaceutical formulations?

A: Hydroxyurea IP/USP provides high purity (99%), stringent microbial and solvent controls, robust packaging, and reliable performance, making it ideal for safe and effective pharmaceutical and research use.

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