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Pharmaceutical Chemistry
Zoledronic acid monohydrate
Formula:
C5H10N2O7P2Zn·H2O
GOST/CAS:
165800-06-6
Product Description: Zoledronic acid monohydrate is a highly potent, concentrated Active Pharmaceutical Ingredient (API) belonging to the class of third-generation nitrogen-containing bisphosphonates. It exerts a powerful, selective action on bone tissue by inhibiting osteoclast activity and bone resorption structures. This product serves as an essential raw material for pharmaceutical manufacturers specializing in the formulation of injectable dosage forms and intravenous infusions utilized in the treatment of severe metabolic bone disorders and oncological complications.
Applications
Oncology Practice: Used as a critical component in manufacturing formulations intended for the prevention and treatment of skeletal-related events (pathological fractures, spinal cord compression) in patients with advanced-stage malignancies.
Hypercalcemia Management: Applied in the synthesis of emergency medications designed to rapidly reduce critical calcium levels in the blood serum induced by tumor processes (tumor-induced hypercalcemia).
Osteoporosis Therapy: Highly demanded in the production of prolonged-release infusion solutions for the systemic treatment of various types of osteoporosis (postmenopausal, senile, glucocorticoid-induced) aimed at drastically lowering fracture risks.
Paget's Disease: Integrated into therapeutic protocols to formulate medications that normalize bone metabolism and slow down abnormal bone remodeling in osteitis deformans.
Key Advantages
Superior Antiresorptive Potency: Recognized as one of the most powerful known inhibitors of osteoclastic bone resorption among nitrogenous bisphosphonates, providing target-specific action on affected bone areas.
Pharmaceutical Purity (API): Manufactured in strict accordance with current GMP standards, guaranteeing minimal impurity profiles, consistent particle size distribution, and the safety of the final injectable dosage form.
Cost & Manufacturing Efficiency: Due to its ultra-low therapeutic dosage requirements (typically 4 mg or 5 mg per vial), it significantly minimizes raw material shipping and storage costs while allowing easy concentration adjustments during final compounding.
Targeted Mechanism of Action: Possesses an extremely high affinity for mineralized bone tissues, rapidly localizing in zones of active mineral remodeling to ensure long-lasting therapeutic efficacy.
Storage & Transportation
- Store in dry, clean, cool warehouse environments inside tightly sealed original containers or hermetically enclosed packaging, well protected from direct sunlight, heat sources, and moisture.
- Recommended storage temperature range: +15°C to +30°C (controlled room temperature). Avoid abrupt temperature fluctuations.
- The product is classified as a potent pharmaceutical substance; personnel handling the material must strictly utilize Personal Protective Equipment (PPE), including respirators, protective gloves, and safety goggles.
- Transportation is permissible via all standard covered transport means in full compliance with logistics regulations for high-purity chemical and pharmaceutical cargo, ensuring comprehensive protection against atmospheric precipitation and mechanical damage. Shelf life is 3 years from the date of manufacture, provided container integrity remains intact.
Technical Specifications
Appearance
White or almost white crystalline powder
Assay (Purity)
99.0% – 101.0% (calculated on the anhydrous basis)
Water Content (Karl Fischer)
5.5% – 7.0%
Heavy Metals
Not more than 0.001% (10 ppm)
Sulfated Ash
Not more than 0.1%
Single Impurity
Not more than 0.1%
Total Impurities
Not more than 0.5%
Solubility
Sparingly soluble in water, moderately soluble in 0.1M NaOH solution
Supply info
- Packaged in double hermetic polyethylene liners placed inside multi-layer fiber drums available in 1 kg, 5 kg, 10 kg, and 25 kg capacities (export standard).
- Small-scale customized packaging layouts can be arranged upon request for research institutions, laboratories, and R&D centers.