Description

Malic Acid Impurity 2 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity and safety of malic acid, a widely used food acidulant and pharmaceutical excipient. It is primarily required by analytical laboratories, quality assurance departments, and research institutions in the pharmaceutical, food, and nutraceutical industries for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material (CRM) for the identification and quantification of impurities in malic acid active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used as a critical standard to develop, validate, and verify HPLC, UPLC, and GC methods for purity analysis.
• Quality Control & Assurance (QC/QA): Essential for in-house quality control testing to monitor batch-to-batch consistency and ensure compliance with pharmacopeial standards (USP, EP, JP).
• Food & Beverage Industry Analysis: Employed to assess the purity of malic acid used as a food additive (E296) for flavor enhancement and acidity regulation.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing definitive impurity characterization data for drug master files (DMFs) and marketing authorization applications.
• Research & Development: Used in stability studies, degradation pathway elucidation, and synthetic chemistry research related to malic acid and its derivatives.

Basic Information

Product Name	Malic Acid Impurity 2
CAS No.	1800467-68-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Malic Acid Related Compound; Malic Acid Specified Impurity; Hydroxysuccinic Acid Impurity; (2S)-2-Hydroxybutanedioic Acid Impurity; L-Malic Acid Impurity; Food Additive E296 Impurity; Pharmaceutical Secondary Standard; Analytical Reference Standard
EINECS	Contact for details

Quality Control

Every batch of Malic Acid Impurity 2 is manufactured and handled 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 reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results from advanced analytical techniques. We support compliance with ICH Q3A/B guidelines and pharmacopeial 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. Keep the container in a dry, well-ventilated area. Handle and store in accordance with good laboratory practice.

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 impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits
Water Content (KF)	≤ 5.0%

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