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The Significance of Assay Purity in Pharmaceutical Intermediates

In the pharmaceutical industry, the purity of chemical compounds is paramount, especially for intermediates used in the synthesis of active pharmaceutical ingredients (APIs). Assay purity refers to the percentage of the desired compound present in a sample, with higher purity indicating fewer impurities. NINGBO INNO PHARMCHEM CO.,LTD. places a strong emphasis on achieving high assay purity, often exceeding 98.0%, for its range of pharmaceutical intermediates, recognizing its direct impact on drug safety and efficacy.

Take, for instance, the benzonitrile derivative 4-(6-amino-2-(4-cyanophenylamino)pyrimidin-4-yl)oxy-3,5-dimethylbenzonitrile. This compound is a key intermediate in the production of Etravirine, an important drug for managing HIV infections. If this intermediate contains significant levels of impurities, it can lead to several problems in the manufacturing process. These include reduced yields of Etravirine, the formation of undesirable byproducts that are difficult to remove, and potentially the introduction of toxic substances into the final drug product.

Achieving high assay purity requires meticulous control over the chemical synthesis process. This involves carefully selecting starting materials, optimizing reaction conditions, and employing efficient purification techniques. NINGBO INNO PHARMCHEM CO.,LTD. invests in advanced manufacturing capabilities and rigorous quality control measures to ensure that our intermediates consistently meet stringent purity specifications. This commitment translates into tangible benefits for our clients, enabling them to produce APIs that are pure, potent, and safe.

The importance of purity extends to the role of intermediates as reference standards. For analytical purposes, such as validating analytical methods or identifying potential impurities like Etravirine impurity D, a highly pure reference material is indispensable. When an intermediate is supplied with a guaranteed high assay purity, it simplifies the process of method development and validation, ensuring accurate and reliable analytical results. This is crucial for meeting regulatory requirements and maintaining the highest quality standards throughout the drug lifecycle.

Ultimately, the investment in high-purity pharmaceutical intermediates by companies like NINGBO INNO PHARMCHEM CO.,LTD. is an investment in patient safety and therapeutic success. By providing reliable building blocks with well-defined purity profiles, we empower our partners in the pharmaceutical industry to manufacture drugs that are not only effective but also meet the highest global standards of quality and safety. The purchase of such critical materials is a cornerstone of responsible pharmaceutical manufacturing.

Manufacturing Facilities

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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WHY CHOSE US?

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.

CONTACT US
Should you need to contact us; you may call during regular business hours, Monday through Friday, 8am – 6 pm.
NINGBO INNO PHARMCHEM CO.,LTD.
Address: No.163 Ruiqing Rd.,Ningbo 315000 China
Phone: 86-574-87319282
Fax: 86-574-27912196
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