Description

Rapamycin Impurity 6 is a designated chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the purity, safety, and efficacy of Rapamycin (Sirolimus) and its derivatives during pharmaceutical development and quality control. It is primarily required by research institutions, pharmaceutical manufacturers, and analytical laboratories engaged in the synthesis, purification, and regulatory compliance of immunosuppressant drugs.

Application

• Pharmaceutical Reference Standard: Serves as a critical impurity marker for the identification and quantification of related substances in Rapamycin (Sirolimus) active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used in HPLC, LC-MS, and other chromatographic methods to establish system suitability, specificity, and detection limits for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for batch release testing of Rapamycin to comply with pharmacopeial standards (e.g., USP, EP) and regulatory guidelines (ICH Q3A/B).
• Stability Studies: Employed to monitor the formation of degradation products in Rapamycin formulations under various stress conditions.
• Process Chemistry Research: Used to study and optimize synthesis pathways, helping to minimize the formation of this specific impurity during manufacturing.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).

Basic Information

Product Name	Rapamycin Impurity 6
CAS No.	500733-49-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sirolimus Impurity 6; 39-O-Demethyl-16-O-demethyl-27-demethoxy-rapamycin; 16,39-Bis-O-demethyl-27-demethoxy Rapamycin; Rapamycin Related Compound 6; (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4]oxazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone
EINECS	Contact for details

Quality Control

Our Rapamycin Impurity 6 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with specification
Residual Solvents (GC)	Complies with ICH guidelines

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