Description

Pimecrolimus is a selective calcineurin inhibitor belonging to the class of ascomycin macrolactam derivatives. This compound is valued for its potent anti-inflammatory and immunomodulating properties, making it a critical active pharmaceutical ingredient (API). It is primarily utilized in the pharmaceutical industry for the development and manufacture of topical dermatological treatments, offering a targeted therapeutic approach for specific inflammatory skin conditions.

Application

• Primary Pharmaceutical API: Manufacture of topical creams and ointments for the treatment of atopic dermatitis (eczema).
• Dermatological Research: A key compound in preclinical and clinical research for inflammatory and autoimmune skin disorders.
• Drug Formulation Development: Used in the R&D of novel topical formulations aiming for enhanced skin penetration and localized efficacy.
• Comparator/Reference Standard: Serves as a high-purity reference standard in analytical laboratories for quality control and method validation.
• Veterinary Medicine: Potential application in topical treatments for inflammatory skin conditions in animals.

Basic Information

Product Name	Pimecrolimus
CAS No.	137071-32-0
Molecular Formula	C43H68ClNO11
Molecular Weight	810.46 g/mol
Synonyms	ASM 981; SDZ ASM 981; Elidel (Trade Name); (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-1-[(1R,3R,4S)-4-Chloro-3-methoxycyclohexyl]prop-1-en-2-yl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-azatricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetrone; 33-Epi-chloro-33-desoxyascomycin
EINECS	Contact for details

Quality Control

Our Pimecrolimus is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with specifications for identity, purity, and impurity profiles.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Keep the container tightly sealed in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Loss on Drying	≤ 1.0%

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