Description

Aciclovir Impurity D (EP) is a specified impurity of the antiviral drug Aciclovir, used for analytical reference and quality control purposes. This high-purity reference standard is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and quality assurance departments for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Aciclovir Impurity D in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or other chromatographic methods to monitor impurities in Aciclovir batches.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for preparing calibration curves to ensure analytical procedures meet pharmacopeial requirements (EP, USP).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Research & Development (R&D): Utilized in pharmaceutical R&D to study the impurity profile, synthesis pathways, and degradation mechanisms of Aciclovir.

Basic Information

Product Name	Aciclovir Impurity D (EP)
CAS No.	59277-91-7
Molecular Formula	C8H11N5O3
Molecular Weight	225.21 g/mol
Synonyms	9-[(2-Hydroxyethoxy)methyl]guanine Impurity D; Acyclovir Impurity D; 2-Amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; EP Impurity D of Aciclovir; Aciclovir Related Compound D; European Pharmacopoeia Impurity D; Guanine, 9-[(2-hydroxyethoxy)methyl]-; Acyclovir EP Impurity D
EINECS	Contact for details

Quality Control

Our Aciclovir Impurity D (EP) is manufactured and controlled to meet the stringent requirements for pharmaceutical reference standards. Each batch undergoes rigorous analytical testing, including HPLC purity determination, spectroscopic identification (IR, NMR), and loss on drying analysis. We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and spectral data to support your regulatory and quality needs.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0%
Total Impurities	≤ 2.0%
Loss on Drying	≤ 1.0%

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