Omeprazole (CAS 73590-58-6) Reference Standard and Impurity Standards: Key Factors in Pharmaceutical Testing
Omeprazole, a crucial pharmaceutical active ingredient for treating gastric and esophageal conditions, is increasingly affirming its indispensable role in modern medicine. As a selective and irreversible proton pump inhibitor, Omeprazole is widely used to treat gastroesophageal reflux disease (GERD) and peptic ulcers. To ensure the absolute therapeutic efficacy and safety of the drug, strict quality control through Omeprazole (CAS 73590-58-6) reference standards and Omeprazole impurity standards is extremely essential. This article will introduce a reliable solution for providing high-quality reference and impurity standards, meeting the most stringent requirements of the pharmaceutical industry.
Detailed information about Omeprazole reference standards
- Chemical Name: Omeprazole
- CAS Number: 73590-58-6
- Molecular Formula: C17H19N3O3S
- Molecular Weight: 345.42
- Synonyms: 6-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole; 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole; (±)-Omeprazole; Antra; Gastrogard; Gastroloc; Losec; Mepral; Mopral; Omepral; Prilosec; Zoltum (USP)
- Classification: Pharmaceutical standard, intermediate, fine chemical
- Form: White powder
- Storage Conditions: 2-8°C (refrigerated)
The Superior Importance of Omeprazole Reference and Impurity Standards
In the field of pharmaceutical manufacturing and testing, quality control is a key factor in ensuring product safety, efficacy, and regulatory compliance. For Omeprazole, the use of pharmaceutical reference standards and **Omeprazole impurity standards** plays an extremely important role in many aspects:
- Qualitative and Quantitative Analysis: Omeprazole (CAS 73590-58-6) reference standard helps accurately determine the Omeprazole content in the final product, ensuring correct dosage and therapeutic efficacy.
- Purity Control: Omeprazole impurity standards help assess the presence and content of impurities that may arise during synthesis or storage. Impurity control is mandatory to prevent unwanted substances from affecting drug quality and safety.
- Research and Development (R&D): Reference and impurity standards support the active pharmaceutical ingredient (API) synthesis process, formulation optimization, and stability testing of Omeprazole under various conditions.
- Ensuring Compliance with International Pharmacopoeias: The use of pharmacopoeial reference and impurity standards (such as USP, EP, BP, JP) is a mandatory requirement for pharmaceutical manufacturers to comply with strict industry regulations, thereby ensuring that products are permitted for global market circulation.
Reliable Source for Omeprazole Reference and Impurity Standards
We are proud to be a trusted supplier of high-quality Omeprazole (CAS 73590-58-6) reference standards and Omeprazole impurity standards, meeting all the stringent requirements of the pharmaceutical industry. Our product portfolio includes reference standards for Omeprazole API, pharmacopoeial and non-pharmacopoeial impurities, as well as stable isotopes. Specifically:
- Omeprazole API (Active Pharmaceutical Ingredient) reference standard: The purest form of active ingredient material for use as a primary reference standard.
- Pharmacopoeial impurities of Omeprazole: Includes impurities listed and controlled according to international pharmacopoeias such as USP, EP, BP.
- Non-pharmacopoeial impurities of Omeprazole: Other impurities that may arise but are not yet officially listed in the pharmacopoeia, still needing to be controlled to ensure product safety.
- Stable isotopes of Omeprazole: Isotopic versions of Omeprazole used in advanced research, mass spectrometry analysis, and bioavailability testing.
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- Guaranteed quality: All reference standards and impurity standards are rigorously tested, ensuring the highest purity and accuracy, accompanied by a complete Certificate of Analysis (CoA).
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- Compliance with international standards: Our products meet and exceed international standards, including requirements from USP, EP, BP, helping customers easily comply with regulations.
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- Optimal storage and transportation: Products are stored under ideal conditions (2-8°C) and transported under standard conditions to maintain the best quality from our warehouse to the customer’s hands.
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Investing in high-quality Omeprazole (CAS 73590-58-6) reference standards and Omeprazole impurity standards is not only a mandatory requirement but also a key factor in ensuring the safety and efficacy of your pharmaceutical products. Let us be your trusted partner in your quality control journey.
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