Description

Ibandronate Impurity 1 (Ibandronate EP Impurity B) is a designated impurity standard used in the pharmaceutical development and quality control of Ibandronate sodium, a bisphosphonate drug. This reference material is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by enabling accurate identification and quantification of related substances. It is primarily required by analytical laboratories, quality assurance departments, and regulatory affairs teams within pharmaceutical companies and contract research organizations (CROs) to meet stringent pharmacopeial standards for drug substance characterization.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Ibandronate sodium API and finished dosage forms.
• Regulatory Compliance & Filings: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies as per ICH Q3A/B guidelines.
• Stability Studies: Used to monitor the formation and levels of this specific impurity during forced degradation and long-term stability studies of Ibandronate products.
• Analytical Method Development: A key component in developing and optimizing chromatographic methods, such as HPLC and UPLC, for the precise separation and analysis of Ibandronate and its related substances.
• Pharmacopeial Testing: Employed to verify compliance with monographs from the European Pharmacopoeia (EP), United States Pharmacopeia (USP), and other international pharmacopeias that specify limits for related compounds.
• Manufacturing Process Control: Used to monitor and control the synthesis process of Ibandronate, helping to optimize reaction conditions and purification steps to minimize impurity formation.

Basic Information

Product Name	Ibandronate Impurity 1 (Ibandronate EP Impurity B)
CAS No.	128202-57-3
Molecular Formula	C9H23NO7P2
Molecular Weight	319.23 g/mol
Synonyms	Ibandronate Related Compound B; (3-(Methylpentylamino)-1-hydroxypropane-1,1-diyl)bis(phosphonic acid); Ibandronic Acid Impurity B; Ibandronate Sodium Impurity B; Ibandronate EP Impurity B; Ibandronate USP Related Compound B; BN-1 Impurity; 1-Hydroxy-3-(methylpentylamino)propylidene-1,1-bisphosphonic Acid
EINECS	Contact for details

Quality Control

Every batch of Ibandronate Impurity 1 is produced and analyzed under strict quality management systems. The material undergoes comprehensive characterization and purity verification using advanced analytical techniques including HPLC, NMR, and mass spectrometry to ensure it meets the exacting standards required for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity, and chromatographic profile against relevant pharmacopeial expectations.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Chromatographic Purity (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%

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