Description

Mannose Impurity 1 CAS NO 83377-37-1 is a high-purity chemical reference standard used for the identification and quantification of a specific process-related impurity in D-Mannose and its derivative products. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical and nutraceutical ingredients. It is primarily required by analytical laboratories, quality control departments, and research scientists in the pharmaceutical, biotechnology, and dietary supplement industries for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the analysis of D-Mannose active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC analytical methods to monitor and control impurity profiles.
• Quality Control & Assurance: Provides a benchmark for impurity identification and quantification in routine QC testing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed in forced degradation and long-term stability studies of Mannose-based formulations to track impurity formation over time.
• Research & Development: Used in synthetic chemistry R&D to understand and optimize manufacturing processes to minimize this specific impurity.

Basic Information

Product Name	Mannose Impurity 1
CAS No.	83377-37-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	D-Mannose Impurity 1; D-Mannose Related Compound 1; Mannose Process Impurity; (2R,3S,4R,5S)-2,3,4,5,6-Pentahydroxyhexanal Impurity; Hexose Impurity; Sugar Alcohol Impurity; Carbohydrate Impurity Standard
EINECS	Contact for details

Quality Control

Every batch of Mannose Impurity 1 is manufactured and handled under strict quality management systems. The product undergoes comprehensive analytical testing, including chromatographic purity assay and identity confirmation, to ensure it meets the high standards required for use as a reference material. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results. Our quality commitment aligns with cGMP principles where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Impurities (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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