In the demanding world of pharmaceutical development and quality control, precision is paramount. Active Pharmaceutical Ingredients (APIs) like Semaglutide, a critical peptide used in diabetes and weight management therapies, require rigorous analytical scrutiny to ensure their safety, efficacy, and consistency. High-Performance Liquid Chromatography (HPLC) stands as a cornerstone technique for this purpose, enabling the separation, identification, and quantification of complex molecules. The foundation of any reliable HPLC method, especially for a molecule as significant as Semaglutide, begins with unequivocal identification, and this is where the Semaglutide CAS number plays an indispensable role. Companies specializing in the production and global supply of high-purity APIs, such as Hebei Weimiao Import and Export Trade Co., Ltd., understand this fundamental requirement intimately.

Hebei Weimiao Import and Export Trade Co., Ltd. operates at the forefront of the fine chemical industry, specializing in the research, development, manufacturing, and marketing of APIs and pharmaceutical intermediates. Supported by two affiliated manufacturers strategically located in Hebei, a beautiful coastal city in eastern China, the company has cultivated a robust professional team and implemented advanced management systems. With a strong export focus – over 70% of products reach markets in Europe, America, Japan, and Southeast Asia – Hebei Weimiao excels in product sourcing and the development of custom synthesis solutions. Their commitment to "Credibility, Quality, and Customer First" underpins every operation, fostering tight, reliable partnerships with global clients seeking consistent, high-quality chemical products like Semaglutide in bulk quantities.

The Critical Role of the Semaglutide CAS Number in HPLC Validation 

The Semaglutide CAS number is not merely an identifier; it is the anchor point for all analytical activities concerning this specific molecule. During HPLC method validation – the process of proving that an analytical method is suitable for its intended purpose – the CAS number serves several vital functions:

l Unambiguous Reference: It eliminates ambiguity. Semaglutide might be referred to by various synonyms or trade names, but the semaglutide cas no (CAS 910463 68 2) is universally recognized in chemical databases, regulatory filings (like DMFs), and scientific literature. This ensures everyone involved – from the manufacturer (like Hebei Weimiao's affiliated producers) to the QC lab and regulatory bodies – is discussing and analyzing the exact same chemical entity.

l Traceability of Standards: Certified Reference Standards (CRS) used for HPLC method development and validation are directly linked to their CAS number. When procuring or preparing Semaglutide standards for establishing calibration curves, assessing linearity, or determining accuracy, the Semaglutide CAS number guarantees the correct reference material is used, forming the bedrock of reliable quantitative results.

l Method Specificity Confirmation: A key validation parameter is specificity – the ability to accurately measure the analyte (Semaglutide) in the presence of potential interferences like impurities, degradation products, or matrix components. Confirming the identity of the main peak in the chromatogram as Semaglutide CAS 910463-68-2, often through techniques like mass spectrometry (coupled with HPLC), relies on this unique identifier to correlate the observed peak with the target molecule.

l Regulatory Compliance: Regulatory submissions (e.g., to FDA, EMA) mandate clear identification of the substance under test. The semaglutide cas no is a mandatory element in method validation protocols and reports, providing a clear link between the validated method and the specific API it controls.

For a global supplier like Hebei Weimiao, ensuring the correct Semaglutide CAS number is integrated into all analytical documentation is fundamental to demonstrating product quality and meeting international regulatory expectations for their bulk API shipments.

Ensuring Accuracy with the Correct Semaglutide CAS No in Analytical Protocols

Implementing robust analytical control for Semaglutide hinges on precise protocols. The semaglutide cas no (910463-68-2) must be explicitly stated in all relevant documentation:

l Standard Operating Procedures (SOPs): All HPLC method SOPs must clearly identify the analyte using its CAS number.

l Specifications: Release and stability specifications for the Semaglutide API batch must reference CAS 910463 68 2.

l Certificate of Analysis (CoA): The CoA accompanying every batch supplied by Hebei Weimiao or its manufacturers prominently features the Semaglutide CAS number alongside critical quality attributes determined by validated methods, including HPLC purity and related substances.

l Stability Study Protocols/Reports: When assessing the stability of Semaglutide under various conditions using HPLC, the substance is unequivocally identified by its CAS number.

Any deviation from using the correct identifier risks analytical error, misidentification, and potential non-compliance. Hebei Weimiao's adherence to stringent quality management systems ensures that the semaglutide cas no is consistently and correctly applied throughout their manufacturing and quality control processes for Semaglutide.

Key Specifications of Semaglutide CAS 910463 68 2 for HPLC Analysis

Hebei Weimiao supplies Semaglutide (CAS 910463 68 2) meeting high-quality standards suitable for pharmaceutical use and stringent analytical control. The following table summarizes the critical product parameters relevant to HPLC method development and validation:

This specification profile, particularly the >98% HPLC purity, is essential for reliable HPLC analysis. High purity minimizes interference from impurities during method validation and routine testing. The solubility in DMSO facilitates the preparation of stock solutions for standards.

FAQs about Semaglutide CAS Number and HPLC Analysis

Why is the exact Semaglutide CAS number critical when developing an HPLC method?

The Semaglutide CAS number (910463-68-2) is critical because it provides an unambiguous, globally recognized identifier for the specific molecule. This ensures the correct chemical entity is targeted during method development, the appropriate reference standard is used, and all analytical data and regulatory documentation are accurately linked to Semaglutide itself, preventing errors or confusion with similar compounds.

How does confirming the semaglutide cas no aid in HPLC method validation specificity? 

Confirming the semaglutide cas no (910463-68-2) is central to establishing specificity. Techniques like LC-MS (Liquid Chromatography-Mass Spectrometry) used during validation confirm that the main peak observed in the HPLC chromatogram corresponds definitively to the molecular structure associated with CAS 910463 68 2, proving the method can distinguish Semaglutide from potential interfering substances like impurities or degradation products.

Where must the CAS 910463 68 2 identifier appear in Semaglutide quality documentation? 

The identifier CAS 910463 68 2 must appear prominently on all key quality documents, including the product specification, the Certificate of Analysis (CoA) for each batch, the validated HPLC method Standard Operating Procedure (SOP), stability study protocols and reports, and regulatory submissions (e.g., Drug Master Files - DMFs). This ensures traceability and regulatory compliance.

What purity level is typically required for Semaglutide CAS 910463 68 2 used as an analytical standard? 

Certified Reference Standards (CRS) used for quantitative HPLC analysis, particularly during method validation (for accuracy, linearity), require very high purity, often exceeding 98% or meeting specific pharmacopeial grade requirements (e.g., USP, EP). While the API supplied by manufacturers like Hebei Weimiao's affiliates for production is also high purity (>98%), CRS undergo additional rigorous characterization and certification.

Does the stability of Semaglutide CAS 910463 68 2 impact HPLC method validation for stability studies? 

Absolutely. Understanding the inherent stability profile of Semaglutide CAS 910463 68 2 under various conditions (temperature, humidity, light, pH) is crucial. HPLC methods validated for stability-indicating purposes must be able to accurately separate and quantify Semaglutide from its degradation products formed under these stress conditions. The validated method directly monitors the stability defined for the API batch stored as specified (e.g., -20°C long term).

The Semaglutide CAS number (910463-68-2) is far more than a catalogue entry; it is the fundamental linchpin for establishing identity, traceability, and reliability in the HPLC analysis of this vital therapeutic peptide. Its consistent and correct application throughout method validation – from specificity confirmation to standard traceability and regulatory documentation – is non-negotiable for ensuring the quality, safety, and efficacy of Semaglutide API. Companies like Hebei Weimiao Import and Export Trade Co., Ltd., with their dedicated focus on API and intermediate manufacturing, robust quality systems, and commitment to "Credibility, Quality, and Customer First," are pivotal partners in the global pharmaceutical supply chain. By providing high-purity Semaglutide (CAS 910463 68 2) in bulk quantities, backed by reliable logistics and clear identification, they support the development and consistent production of life-changing medicines, underpinned by scientifically sound and meticulously validated analytical control methods like HPLC.