Description

Disodium Pamidronate is a high-purity bisphosphonate compound, essential for its potent inhibitory action on osteoclast-mediated bone resorption. This makes it a critical active pharmaceutical ingredient (API) for the formulation of injectable medications used in the treatment of bone disorders. It is primarily required by pharmaceutical manufacturers and research institutions developing therapies for conditions such as Paget's disease, hypercalcemia of malignancy, and osteoporosis. Our supply ensures consistent quality and reliable availability for global pharmaceutical production.

Application

• Primary Active Pharmaceutical Ingredient (API) in injectable formulations for the treatment of hypercalcemia of malignancy.
• Key therapeutic agent in medications for Paget's disease of bone (osteitis deformans).
• Clinical use in the management of osteolytic bone metastases associated with cancers such as breast cancer and multiple myeloma.
• Treatment of osteoporosis, particularly in cases requiring potent antiresorptive therapy.
• Research and development of novel bone-targeted drug delivery systems and therapeutic conjugates.
• Reference standard in analytical laboratories for quality control and method validation of pamidronate-based products.

Basic Information

Product Name	Disodium Pamidronate
CAS No.	106437-12-1
Molecular Formula	C3H9NNa2O7P2
Molecular Weight	279.03 g/mol
Synonyms	Pamidronate Disodium; Pamidronic Acid Disodium Salt; Disodium (3-Amino-1-hydroxypropylidene)bisphosphonate; APD; CGP 23339; Aredia (Brand Name API); Aminohydroxypropylidene Bisphosphonate Disodium; Disodium 3-Amino-1-hydroxypropylidene-1,1-bisphosphonate
EINECS	Contact for details

Quality Control

Our Disodium Pamidronate is manufactured under strict quality systems suitable for pharmaceutical use. It is tested to meet stringent in-house specifications aligned with major pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing results for identity, purity, assay, and impurity profiles. We support our partners with full traceability and documentation for regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
pH (1% Solution)	7.5 - 9.0
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Bacterial Endotoxins	< 1.0 EU/mg
Sterility (for sterile grade)	Sterile

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.