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In the pharmaceutical industry, the quality of raw materials is a direct determinant of the safety and efficacy of the final drug product. Metronidazole (CAS 443-48-1), a crucial pharmaceutical intermediate, demands rigorous quality control throughout its manufacturing process. For buyers seeking to purchase Metronidazole, understanding these quality parameters and the certifications of their suppliers is essential.
The Imperative of Purity:
Metronidazole's primary role as an intermediate means it is incorporated into complex drug synthesis pathways. The presence of impurities, even in trace amounts, can lead to:
* Reduced Yields: Impurities can interfere with chemical reactions, lowering the efficiency of synthesis.
* Formation of Undesirable Byproducts: These byproducts may be toxic or reduce the therapeutic effectiveness of the final drug.
* Batch Rejection: Failure to meet strict purity specifications can result in costly batch rejections.
Therefore, pharmaceutical-grade Metronidazole typically requires a purity assay of ≥99%. This is verified through various analytical techniques, including High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and spectrophotometry.
Key Quality Control Parameters:
Beyond overall purity, several specific parameters are monitored:
* Identification: Confirmation of the substance's identity using techniques like Infrared (IR) spectroscopy.
* Related Substances/Impurities: Quantification of specific known and unknown impurities according to pharmacopeial standards (e.g., USP, EP).
* Heavy Metals: Limits on heavy metal contamination are crucial for patient safety.
* Loss on Drying/Water Content: To ensure stability and accurate dosing.
* Residue on Ignition: Indicates the level of inorganic impurities.
Certifications and Supplier Verification:
When sourcing Metronidazole CAS 443-48-1, look for suppliers who can provide robust documentation. This includes:
* Certificate of Analysis (CoA): A batch-specific document detailing all the tested quality parameters and their results.
* ISO Certifications: Standards like ISO 9001 demonstrate a commitment to a quality management system.
* Compliance with Pharmacopeias: If required, verification that the product meets specific pharmacopeial monographs (e.g., USP, EP, JP).
As a leading manufacturer and supplier of Metronidazole in China, we place paramount importance on quality control. Our facilities are ISO certified, and we rigorously test every batch to ensure it meets or exceeds the ≥99% purity standard required for pharmaceutical applications. We are committed to transparency and provide comprehensive CoAs with every shipment. Partner with us to ensure your Metronidazole supply is consistently of the highest quality, providing peace of mind for your critical manufacturing processes.
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1. 20 years of R&D, manufacturing and sales experience, serving customers in 60 countries and regions around the world;
2. Own R&D laboratory, pilot platform and large-scale production workshop, which can meet the audit requirements of global customers;
3. We can satisfy customers' perfect transition from small scale lab requirements (gram level) to commercialization requirements (hundred tons level).
A: We don't have Minimum Order Quantity, exact quantity should be provided before quotation for us to calculate the exact cost.
A: We don't provide free samples due to lots of request and expensive international courier's cost, we can deduct the sample charge after commercial order placed.
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