Description

Pamidronate Disodium Salt is a high-purity, nitrogen-containing bisphosphonate compound. It serves as a critical active pharmaceutical ingredient (API) for the formulation of injectable medications used to manage bone metabolism disorders. This product is essential for pharmaceutical manufacturers and research institutions developing treatments for conditions such as hypercalcemia of malignancy and Paget's disease. Its consistent quality and reliable supply are paramount for ensuring the safety and efficacy of the final therapeutic products.

Application

• Pharmaceutical API: Primary use as the active ingredient in sterile injectable formulations for treating bone-related conditions.
• Hypercalcemia of Malignancy: Used in medications to lower elevated blood calcium levels caused by cancer.
• Paget's Disease of Bone: A key therapeutic agent for regulating abnormal bone remodeling in this chronic disorder.
• Osteolytic Bone Metastases: Incorporated into therapies to reduce skeletal complications and bone pain in patients with metastatic cancers.
• Research & Development: Serves as a reference standard and building block in pharmacological and biochemical research on bone metabolism.
• Generic Drug Manufacturing: A vital component for companies producing generic versions of bisphosphonate-based injectable drugs.

Basic Information

Product Name	Pamidronate Disodium Salt
CAS No.	57248-88-1
Molecular Formula	C3H9NNa2O7P2
Molecular Weight	279.03 g/mol (Anhydrous)
Synonyms	Pamidronate Disodium; Pamidronic Acid Disodium Salt; Disodium Pamidronate; APD; (3-Amino-1-hydroxypropylidene)bisphosphonic Acid Disodium Salt; Aminohydroxypropylidene Bisphosphonate Disodium; Aredia (Brand Name API); CGP 23339
EINECS	Contact for details

Quality Control

Our Pamidronate Disodium Salt is manufactured and tested under strict quality management systems. It is produced to meet exacting standards suitable for pharmaceutical applications, with typical purity levels exceeding 98.5%. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing identity, purity, impurity profile, and other critical parameters. We ensure compliance with relevant ICH guidelines and support our customers with full traceability and regulatory documentation.

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. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Water Content (KF)	≤ 2.0%
pH (1% Solution)	7.5 - 9.0
Heavy Metals	≤ 20 ppm
Residual Solvents	Complies with ICH Q3C
Related Substances (HPLC)	Total impurities ≤ 1.5%
Bacterial Endotoxins	< 0.5 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.