Amoxicillin Trihydrate Reference Standards (CAS 61336-70-7) and Impurity Standards: Key Factors in Pharmaceutical Testing
Amoxicillin Trihydrate, a crucial antibiotic, continues to assert its indispensable role in the medical field. It is used to treat several bacterial infections. Amoxicillin Trihydrate was discovered in 1958 and began medical use in 1972. To ensure the therapeutic effectiveness and absolute safety of the drug, strict quality control through high-purity Amoxicillin Trihydrate reference standards (CAS 61336-70-7) and Amoxicillin Trihydrate impurity standards is extremely essential. This article will delve into the importance of Amoxicillin Trihydrate and introduce a reliable solution for providing trusted reference and impurity standards, meeting the most stringent requirements of the pharmaceutical industry.
Detailed information about Amoxicillin Trihydrate Reference Standard
- Chemical Name: Amoxicillin Trihydrate
- CAS Number: 61336-70-7
- Molecular Formula: C16H25N3O8S
- Molecular Weight: 419.45
- Synonyms: Amoxycillin Trihydrate; Alfoxil; Amoksina; Amoxykel; Amoxyl; Demoksil; Promoxil; Remoxil; Topramoxin
- Classification: Amines, aromatics, sulphur and selenium compounds, pharmaceutical standards, intermediates, Fine Chemicals
- Form: White to off-white crystalline solid
- Storage Conditions: 2-8°C (refrigerator)
The Superior Importance of Amoxicillin Trihydrate Reference and Impurity Standards
In the field of pharmaceutical manufacturing and testing, quality control is a crucial factor in ensuring product safety, efficacy, and legal compliance. For Amoxicillin Trihydrate, the use of pharmaceutical reference standards and Amoxicillin Trihydrate impurity standards plays an extremely important role in many aspects:
- Qualitative and Quantitative Analysis: Amoxicillin Trihydrate reference standards (CAS 61336-70-7) help accurately determine the Amoxicillin Trihydrate content in the final product, ensuring correct dosage and therapeutic efficacy.
- Purity Control: **Amoxicillin Trihydrate impurity standards** help evaluate 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 Amoxicillin Trihydrate stability testing under various conditions.
- Ensuring Compliance with International Pharmacopoeias: The use of pharmacopoeial reference and impurity standards is a mandatory requirement for pharmaceutical manufacturers to comply with strict industry regulations, thereby ensuring products are permitted for global market circulation.
Reliable Source for Amoxicillin Trihydrate Reference and Impurity Standards
We are proud to be a reputable provider of high-quality Amoxicillin Trihydrate reference standards (CAS 61336-70-7) and Amoxicillin Trihydrate impurity standards, fully meeting the stringent requirements of the pharmaceutical industry. Our product catalog includes Amoxicillin Trihydrate reference standards, pharmacopoeial and non-pharmacopoeial impurities, as well as stable isotopes. Specifically:
- Amoxicillin Trihydrate Reference Standard: The purest form of the active ingredient material for use as a primary standard.
- Pharmacopoeial impurities of Amoxicillin Trihydrate: Includes impurities listed and strictly controlled according to international pharmacopoeial standards.
- Non-pharmacopoeial impurities of Amoxicillin Trihydrate: Other impurities that may arise but are not officially listed in the pharmacopoeia, which still need to be controlled to ensure overall product safety.
- Stable isotopes of Amoxicillin Trihydrate: Isotopic versions of Amoxicillin Trihydrate used in in-depth research, mass spectrometry analysis, and bioavailability testing.
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