Description

Fosaprepitant Dimeglumine CAS NO 265121-04-8 is a water-soluble prodrug of aprepitant, a potent and selective neurokinin-1 (NK1) receptor antagonist. This compound is a critical active pharmaceutical ingredient (API) used in the prevention of chemotherapy-induced nausea and vomiting (CINV). It is essential for pharmaceutical manufacturers developing injectable antiemetic formulations, particularly for patients undergoing highly emetogenic chemotherapy regimens. The product is supplied as a high-purity material to ensure efficacy and safety in final drug products.

Application

• Primary Active Pharmaceutical Ingredient (API) in injectable antiemetic drugs.
• Manufacturing of lyophilized (freeze-dried) powder for injection to prevent acute and delayed CINV.
• Used in combination regimens with other antiemetics like 5-HT3 receptor antagonists and corticosteroids.
• Key component in the development of generic and branded pharmaceutical products targeting nausea control.
• Supplied to contract manufacturing organizations (CMOs) and finished dosage form (FDF) producers.
• Research and development of novel antiemetic formulations and combination therapies.

Basic Information

Product Name	Fosaprepitant Dimeglumine
CAS No.	265121-04-8
Molecular Formula	C23H22F7N4O6P • 2(C7H17NO5)
Molecular Weight	1004.83 g/mol
Synonyms	Fosaprepitant Meglumine; L-758,298; MK-0517; Fosaprepitant dimeglumine salt; (2R,3R,4R,5S)-6-[(3-[(5R)-5-[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)morpholin-4-yl]methyl]-2,5-dihydro-1H-1,2,4-triazol-1-yl]methyl]-3,4,5-trihydroxyoxane-2-carboxylic acid compound with 1-deoxy-1-(methylamino)-D-glucitol (2:1); Aprepitant prodrug
EINECS	Contact for details

Quality Control

Our Fosaprepitant Dimeglumine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for pharmaceutical use, including identity, purity, and impurity profiles. Certificates of Analysis (COA) are provided with each shipment, detailing results from tests such as HPLC assay, related substances, residual solvents, and heavy metals. We support compliance with cGMP, ICH Q7, and relevant pharmacopeial standards (USP/EP) as required.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Water Content (KF)	NMT 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	NMT 20 ppm
Specific Rotation	Contact for details
Bacterial Endotoxins	<0.17 EU/mg

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