Description

5-Deshydroxymethyl-5-Chloro Losartan (Losartan Impurity K) is a specified impurity and degradation product of the widely prescribed antihypertensive drug Losartan. This compound is critical for pharmaceutical research and development, serving as a key reference standard in analytical method development and quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Losartan Potassium active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, validating, and verifying HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to track the formation of this specific degradant under various stress conditions (e.g., heat, humidity, light) as part of drug stability testing.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA) with agencies like the US FDA and EMA.
• Research on Degradation Pathways: Facilitates studies into the chemical stability and degradation mechanisms of Losartan-based pharmaceuticals.

Basic Information

Item	Detail
Product Name	5-Deshydroxymethyl-5-Chloro Losartan (Losartan Impurity K)
CAS No.	1159977-26-0
Molecular Formula	C21H21ClN6O
Molecular Weight	408.89 g/mol
Synonyms	Losartan Impurity K; Losartan Related Compound K; 5-Chloro-5-deshydroxymethyl Losartan; 2-Butyl-4-chloro-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazole-5-methanol (Deshydroxymethyl Chloro Analog); EXP 3174 Impurity; DuP 753 Impurity
EINECS	Contact for details

Quality Control

Every batch of 5-Deshydroxymethyl-5-Chloro Losartan (Losartan Impurity K) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure they meet the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data, including batch-specific results, are provided and traceable to primary standards.

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) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
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.