Description

Simvastatin Impurity 10 is a specified impurity used in the quality control and analytical research of Simvastatin, a widely prescribed cholesterol-lowering medication. This high-purity reference standard is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug safety, efficacy, and regulatory compliance by accurately identifying and quantifying impurities. It is an essential material for method development, validation, and stability studies in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Simvastatin Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development: Crucial for developing and validating High-Performance Liquid Chromatography (HPLC), UPLC, and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing within pharmaceutical QC laboratories to monitor impurity levels against ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of degradation products in Simvastatin under various stress conditions (e.g., heat, light, humidity) as per ICH stability protocols.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data for Drug Master Files (DMFs) and marketing applications.
• Research & Development: Serves as a key intermediate or marker in synthetic chemistry research and process development for Simvastatin and related compounds.

Basic Information

Product Name	Simvastatin Impurity 10
CAS No.	134970-33-5
Molecular Formula	C25H38O5
Molecular Weight	418.57 g/mol
Synonyms	Simvastatin Related Compound C; (1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-Hydroxy-6-oxotetrahydro-2H-pyran-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl (2S)-2-methylbutanoate; Simvastatin EP Impurity C; Simvastatin USP Related Compound C; 3-Hydroxy Simvastatin Lactone; Simvastatin Hydroxy Acid Lactone; Simvastatin Lactone Impurity
EINECS	Contact for details

Quality Control

Our Simvastatin Impurity 10 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the stringent requirements for pharmaceutical reference standards. Each batch is characterized and controlled against comprehensive specifications, including identity, purity, and impurity profile. A detailed Certificate of Analysis (COA) providing batch-specific data from techniques such as HPLC, NMR, and MS is supplied with every product to support your regulatory and quality needs.

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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an 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)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% 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.