Description

Paliperidone Desfluoro Impurity is a key process-related impurity and a critical reference standard used in the pharmaceutical development and quality control of Paliperidone, an atypical antipsychotic medication. This compound is essential for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification of the desfluoro variant during manufacturing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, validation, and batch release of Paliperidone API and its formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the identification and quantification of the desfluoro impurity in Paliperidone Active Pharmaceutical Ingredient (API) and finished drug products.
• Method Development & Validation: Critical for developing and validating robust analytical methods (e.g., HPLC, UPLC) to monitor and control impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release: Used in routine quality control testing to ensure that Paliperidone batches meet stringent purity specifications and regulatory submission requirements.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Compliance & Filing: A necessary component for regulatory documentation (e.g., Drug Master Files, CMC sections) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Process Chemistry Research: Used by R&D scientists to study and optimize synthetic pathways to minimize the formation of this impurity during the manufacturing process.

Basic Information

Product Name	Paliperidone Desfluoro Impurity
CAS No.	1380413-60-4
Molecular Formula	C23H27FN4O3
Molecular Weight	426.49 g/mol
Synonyms	9-Hydroxyrisperidone Desfluoro Impurity; Desfluoro Paliperidone; 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one; Paliperidone EP Impurity G; Paliperidone Related Compound G; (9RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one
EINECS	Contact for details

Quality Control

Our Paliperidone Desfluoro Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate identification. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, supporting its use as a reference standard in regulated environments. The quality commitment aligns with the standards expected for pharmaceutical impurities and reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, 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 solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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