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Quality Assurance for (aR)-4-Chlorophenylglycine Hydrochloride in Pharmaceutical Manufacturing

In the pharmaceutical industry, quality is not merely a benchmark; it is a fundamental requirement that underpins patient safety and therapeutic efficacy. This principle extends rigorously to every component used in drug manufacturing, including chemical intermediates like (aR)-4-Chlorophenylglycine Hydrochloride. Understanding and ensuring the quality of this compound (CAS 108392-76-3) is paramount for any pharmaceutical producer.

The chemical, Benzeneacetic acid, a-amino-4-chloro-, hydrochloride(1:1),( 57187535,aR)-, is characterized by its white powder appearance and a specified purity of ≥99%. This high purity level directly impacts the downstream synthesis process and the final drug product's quality. Impurities, even in trace amounts, can lead to the formation of unwanted byproducts, affect reaction yields, and potentially introduce toxicological risks. Therefore, robust quality control measures are essential at every stage of production and procurement.

Key to quality assurance is the Certificate of Analysis (CoA). A comprehensive CoA for (aR)-4-Chlorophenylglycine Hydrochloride should detail the batch-specific results for purity, identification tests (such as NMR, IR), residual solvents, heavy metals, and most importantly, enantiomeric purity. The (aR) stereochemistry is critical, and suppliers must provide verifiable data confirming the absence or minimal presence of the undesirable (aS) enantiomer. Reputable manufacturers, like NINGBO INNO PHARMCHEM CO.,LTD., prioritize accurate and detailed CoAs to provide transparency and assurance to their clients.

When selecting a supplier to buy alpha-amino-4-chloro-benzeneacetic acid hydrochloride, quality assurance protocols of the manufacturer should be thoroughly vetted. This includes understanding their Good Manufacturing Practices (GMP) compliance, their analytical capabilities, and their systems for batch traceability. Auditing the supplier's facilities, if feasible, can offer direct insight into their commitment to quality and safety standards.

Furthermore, the packaging and handling of the intermediate are also crucial aspects of quality preservation. Proper packaging prevents contamination, degradation, and moisture absorption, ensuring that the product maintains its integrity from the point of manufacture to its use in the pharmaceutical plant. Discussions with suppliers regarding packaging options and recommended storage conditions are therefore an integral part of the quality assurance process.

In summary, for any pharmaceutical manufacturing process that relies on (R)-4-chlorophenylglycine hydrochloride, a stringent quality assurance framework is indispensable. By demanding detailed CoAs, vetting supplier capabilities, and understanding the critical specifications of this chloro-benzeneacetic acid derivative, companies can mitigate risks and ensure the consistent production of safe and effective medicines.

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NINGBO INNO PHARMCHEM CO.,LTD. was established in 2007. It is committed to the R&D, production and sales of raw materials, pharmaceutical intermediates and fine chemicals. We striving to create a high-efficiency and high-quality integrated chemical service platform to better serve domestic and foreign customers.

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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).

FAQ

  • 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.

  • A: Our payment terms: Small or sample order: T/T IN ADVANCE. Commercial order: First order should be by T/T IN ADVANCE or L/C at sight, and following orders T/T 30~90days is acceptable subject to approval of credit application.

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