Description

Malic Acid Impurity 13 is a high-purity reference standard used for the identification, qualification, and quantification of related substances in Malic Acid and its pharmaceutical formulations. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of active pharmaceutical ingredients (APIs) by monitoring and controlling impurity profiles. It is an essential material for quality control laboratories in the pharmaceutical, biotechnology, and fine chemical industries engaged in analytical method development and validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for impurity identification and quantification in Malic Acid API and drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to establish and validate chromatographic methods for impurity profiling and stability-indicating assays.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing to ensure impurity levels are within ICH Q3A/B guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation of degradation products in Malic Acid under various stress conditions (thermal, photolytic, hydrolytic).
• Research & Development: Used in synthetic chemistry R&D to understand and control impurity formation pathways during the manufacturing process of Malic Acid.

Basic Information

Product Name	Malic Acid Impurity 13
CAS No.	225933-67-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Malic Acid Related Compound; Malic Acid Impurity; Malic Acid EP Impurity; Malic Acid USP Impurity; L-Malic Acid Impurity; (S)-Hydroxybutanedioic Acid Impurity; Butanedioic acid, hydroxy-, (2S)-, impurity; 225933-67-5
EINECS	Contact for details

Quality Control

Every batch of Malic Acid Impurity 13 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and stability testing to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results from advanced analytical techniques (HPLC, LC-MS, NMR) is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material should be kept in a dry environment to maintain stability. For long-term storage, consider conditions recommended for high-purity organic compounds.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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