Hydroxyurea

Hydroxyurea

Hydroxyurea factory supplier

  1. English Name: Hydroxyurea (pronounced “hy-drox-ee-yoo-REE-uh”—it’s an oral prescription medication, sometimes sold under brand names like Hydrea or Droxia)
  1. Specification
    • Purity: ≥ 99% pharmaceutical-grade hydroxyurea (HPLC tested—no impurities; formulated into tablets for precise dosing)
    • Solubility: Water-soluble (dissolves easily in water—why it’s made into oral tablets, not oils/creams)
    • Moisture: ≤ 0.5% (keeps tablets stable—no crumbling or loss of potency)
    • Heavy Metals: ≤ 1 ppm (ultra-strict pharmaceutical standards—safe for oral use long-term)
    • Stability: 3+ years in unopened packaging (store at room temp; keep away from heat/moisture)
  1. Appearance: White to off-white crystalline powder (in raw form) or small, round white tablets (for patients)—not a yellowish-white solid with chocolate aroma! It’s odorless and tasteless in tablet form (easy to swallow).
  1. CAS NO.: 127-07-1
  1. Lead time: 3–7 Working Days (we stock pharmaceutical-grade raw material and finished tablets—fast for drug distributors and hospitals)
  1. Package:
    • Small sizes: 100-count/500-count amber plastic bottles (light-proof for patient use; child-resistant caps)
    • Bulk: 25kg pharmaceutical-grade drums (lined with inert aluminum foil—27 drums per tray; shipped with temperature monitoring)
  1. Main Market: Global—North America (hospitals/oncology clinics), Europe (hematology centers), Asia (growing in cancer care). Used by pharmaceutical companies, hospitals, and specialty pharmacies.
  1. Applications & Main Benefits
    • Cancer Treatment (Primary Use)
      • Chronic Myeloid Leukemia (CML): Lowers abnormal white blood cell counts (helps manage the disease long-term)
      • Ovarian Cancer: Used in combination with other chemo drugs (slows tumor growth; improves survival rates)
      • Skin Cancer (Melanoma): Treats advanced cases (shrinks tumors when surgery isn’t an option)
    • Blood Disorders
      • Sickle Cell Anemia: Reduces painful “sickle cell crises” (prevents red blood cells from forming sickle shapes; eases fatigue)
      • Polycythemia Vera: Lowers excess red blood cell/platelet counts (reduces risk of blood clots/strokes)
    • Rare Diseases
      • Essential Thrombocythemia: Controls high platelet counts (prevents dangerous blood clots in small blood vessels)
    • Research Uses
      • HIV: Studied for boosting immune cell production (still experimental—no approved use yet)
      • Psoriasis: Tested for reducing skin inflammation (rarely used; better treatments exist)

Critical Safety Note

Hydroxyurea is a prescription-only medication—never use it without a doctor’s supervision! Side effects can include low blood counts (needing regular lab checks), nausea, or hair thinning. Pregnant people should avoid it (it can harm the fetus). Always get it from licensed pharmacies—counterfeit hydroxyurea is unsafe and ineffective.
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Hydroxyurea: Pharmaceutical-Grade Active Pharmaceutical Ingredient for Hematological Applications – Manufacturer & Exporter Guide

1. What is Hydroxyurea?
For pharmaceutical manufacturers developing essential hematological medications, Hydroxyurea represents a critical active pharmaceutical ingredient (API) with well-established therapeutic significance. This synthetic organic compound, chemically known as hydroxycarbamide, serves as a cornerstone treatment for various blood disorders and certain types of cancer. As a potent ribonucleotide reductase inhibitor, Hydroxyurea plays a vital role in managing sickle cell disease, essential thrombocythemia, and specific leukemias. Our pharmaceutical-grade Hydroxyurea meets stringent international quality standards, ensuring consistent efficacy and safety in final drug formulations.

2. Source, Chemistry & Specifications

  • Production Method: Synthetic organic synthesis under cGMP conditions

  • Chemical Identity: Hydroxycarbamide

  • Chemical Profile:

    • CAS No.: 127-07-1

    • MF: CH₄N₂O₂

    • MW: 76.05 g/mol

    • EINECS: 204-821-7

  • Appearance: White crystalline powder

  • Solubility: Freely soluble in water; soluble in alcohol

  • Purity Grades: 99.0-101.0% USP/EP/JP pharmacopeial standards

3. The Pharmaceutical Standard: Why Our Hydroxyurea Excels
For B2B clients in pharmaceutical manufacturing, our Hydroxyurea API delivers uncompromising quality:

  • Key Advantages:

    • Pharmacopeial Compliance: Meets USP, EP, and JP monographs

    • Exceptional Purity: 99.0-101.0% assay purity with minimal impurities

    • Regulatory Support: Comprehensive documentation for global market authorization

  • Therapeutic Applications:

    • Sickle Cell Disease: Reduces frequency of painful crises and need for blood transfusions

    • Myeloproliferative Disorders: Controls elevated platelet and white blood cell counts

    • Oncology Applications: Used in combination cancer therapies

  • Dosage Guidelines: Typically 15-35 mg/kg daily for sickle cell disease; varies by indication

  • Certifications Available: cGMP, WHO GMP, ISO 9001, EU GMP

  • Target Applications: Prescription medications, hematological formulations, oncology products

  • Safety Profile: Requires medical supervision; pregnancy category D

4. Zhonghong Biotech: Your Pharmaceutical Manufacturing Partner
Sourcing cGMP Hydroxyurea requires pharmaceutical manufacturing expertise.Shaanxi Zhonghong Investment Technology Co., Ltd.brings 28 years of pharmaceutical synthesis experience and state-of-the-art manufacturing capabilities to deliver premium Hydroxyurea API to global markets.

  • Technical Capabilities:

    • Advanced Synthesis: cGMP-compliant manufacturing processes

    • Purification Expertise: Multiple crystallization and purification stages

    • Quality Assurance: Comprehensive testing exceeding pharmacopeial requirements

  • Global Compliance: Full documentation meeting international regulatory standards

5. Scientific Excellence: Mechanism of Action
Hydroxyurea’s therapeutic efficacy stems from its unique mechanism:

  • Inhibits ribonucleotide reductase enzyme

  • Blocks DNA synthesis without affecting RNA or protein synthesis

  • Induces fetal hemoglobin production in sickle cell disease

  • Exhibits cell cycle-specific activity (S-phase)

6. Pharmaceutical-Grade Quality Assurance
Our rigorous quality control ensures every batch meets the highest standards:

Certificate of Analysis (COA) Summary – Hydroxyurea (USP Grade)

Category Parameter Specification Test Method
Identity IR Spectrum Matches USP Reference USP <197>
Assay Hydroxyurea Content 99.0-101.0% USP <341>
Purity Related Substances ≤ 0.5% HPLC
Safety Heavy Metals ≤ 10 ppm USP <231>
Residual Solvents Meet ICH Guidelines GC
Microbiology Total Plate Count ≤ 1000 CFU/g USP <61>
Yeast/Mold ≤ 100 CFU/g USP <61>

7. Advanced Manufacturing Process
Our cGMP-compliant production ensures superior quality:

  1. Chemical Synthesis: Controlled reaction under optimized conditions

  2. Crystallization: Precision crystallization for purity enhancement

  3. Purification: Multiple purification stages

  4. Drying: Controlled drying to optimal moisture content

  5. Milling: Precision particle size control

  6. Quality Control: Comprehensive analytical testing

8. Professional Applications & Usage

  • Pharmaceuticals: Sickle cell disease medications, hematological products

  • Oncology: Combination cancer therapies

  • Research: Investigational therapeutic applications

Dosage & Formulation Guidance:

  • Tablet Formulations: Typically 500mg and 1000mg strengths

  • Capsule Formulations: Various dosage strengths available

  • Compounding: As per specific formulation requirements

9. Global Supply Chain Excellence

  • Packaging: Double polyethylene bags in sealed containers

  • Storage: Room temperature in dry conditions

  • Shelf Life: 36 months when stored properly

  • Logistics: Global shipping with full documentation support

10. Partnership Opportunities
We offer:

  • Custom particle sizes for specific formulations

  • Regulatory support for market authorization

  • Technical documentation for product registration

  • Quality agreements per customer requirements

Contact Our Technical Team:

11. Technical FAQ

  • Q: What pharmacopeial standards do you meet?
    A: We comply with USP, EP, and JP monographs for Hydroxyurea

  • Q: Can you provide different particle sizes?
    A: Yes, we offer various particle sizes for different formulation needs

  • Q: What documentation do you provide?
    A: Comprehensive COA, MSDS, and regulatory support documents

  • Q: Do you offer stability data?
    A: Yes, we provide comprehensive stability data for formulation support

  • Q: What’s your minimum order quantity?
    A: MOQ is 1kg for samples, 25kg for production quantities

12. Final Call to Action
Ensure consistent quality and reliability in your hematological formulations with our pharmaceutical-grade Hydroxyurea. Contact us today to discuss your specific requirements and request samples for your product development.

Contact us now for technical specifications and samples:

References:

  1. USP43-NF38. (2020). Hydroxyurea Monograph. United States Pharmacopeia

  2. FDA. (2023). Approved Drug Products with Therapeutic Equivalence Evaluations

  3. European Pharmacopoeia 10.0. (2020). Hydroxycarbamide Requirements

  4. WHO Model List of Essential Medicines. (2023). Hydroxyurea Inclusion

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