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Aurora Industry Co., Ltd
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Established in: 2019
MOQ: -
Employees: 50+
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Looking for Betadex API 7585-39-9?
- Description:
- Here you will find a list of producers, manufacturers and distributors of Betadex. You can filter on certificates such as GMP, FDA, CEP, Written Confirmation and more. Send inquiries for free and get in direct contact with the supplier of your choice.
- API | Excipient name:
- Betadex
- Synonyms:
- beta-cyclodextrin,Cyclodextrin B,Cycloheptaamylose,Cycloheptaglucan,Cyclomaltoheptaose
- Cas Number:
- 7585-39-9
- DrugBank number:
- DB03995
- Unique Ingredient Identifier:
- JV039JZZ3A
General Description:
Betadex is a chemical compound identified by the CAS number 7585-39-9. It is known for its distinct pharmacological properties and applications.
Classification:
Betadex belongs to the class of organic compounds known as oligosaccharides. These are carbohydrates made up of 3 to 10 monosaccharide units linked to each other through glycosidic bonds, classified under the direct parent group Oligosaccharides. This compound is a part of the Organic compounds, falling under the Organic oxygen compounds superclass, and categorized within the Organooxygen compounds class, specifically within the Carbohydrates and carbohydrate conjugates subclass.
Categories:
Betadex is categorized under the following therapeutic classes: Carbohydrates, Compounds used in a research, industrial, or household setting, Cyclodextrins, Dextrins, Diet, Food, and Nutrition, Dietary Carbohydrates, Excipients, Food, Food Additives, Food Ingredients, Glucans, Pharmaceutic Aids, Pharmaceutical Preparations, Pharmaceutical Vehicles, Physiological Phenomena, Polysaccharides, Sequestering Agents, Starch. These classifications highlight the drug's diverse therapeutic applications and its importance in treating various conditions.
Good Manufacturing Practices
Active pharmaceutical ingredientsare made in GMP-certified manufacturing facilities. GMP stands for Good Manufacturing Practices and is the main standard in the pharmaceutical industry. cGMP or Current GMP means that the company complies with the most recent requirements/version of GMP. The WHO has its own guideline for GMP, the World Health Organization or WHO GMP. The authority that has audited the company can also be from a country like China (Chinese GMP) or from the EU (EU GMP), every authority has different GMP requirements.
Certificate of Analysis
A CoA is a document issued by a companies’ QA/QC-department that confirms that a product meets its product specification and is part of the quality control of a product batch. The CoA commonly contains results obtained from laboratory tests of an individual batch of a product. There are different international standards to which a product can be tested, for example: Ph. Eur. | EP – (European Pharmacopoeia) USP – (United States Pharmacopeia)
Certificate of Suitability
CEP (also known as COS) is a certificate that proves thatqualifies to the relevant monograph of the European Pharmacopoeia. It links the monograph in the Ph.Eur. to the APIitself. A CEP is submitted by the manufactureras part of the market authorization process, and they will become the CEP holder of the document. Being a European certificate, the CEP is granted by the EDQM but is recognized by other countries or institutes such as the FDA in the US. Furthermore, just like the DMF, the data as submitted in the CEP is handled strictly confidential and provides a centralized system recognized by many countries.
Written Confirmation
When an API is imported into the European Union from elsewhere in the world, it should be accompanied by a “written confirmation” (WC). A written confirmation is a document set up by the health authorities of the country where the API was manufactured. After inspections were successfully performed under EU/GMP equivalent standards, the health authorities can provide a WC. These inspections will also have to regularly take place in the future.
Food & Drug Administration approved
The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. FDA is important because it is intended to have companies produce their goods to certain standards and it presents this fact in a clear overview using FDA certificates. When a company is (US) FDA approved, it shows the American government has declared the API or medicine as safe and it can be sold, imported, or used in the United States. The USA is not the only country with a regulatory agency like FDA. Most other countries have agencies that are responsible for the national safety of pharmaceutical products. Some different kinds of organizations include:
EMA (European Medicines Agency, European Union)
MHRA (Medicines and Healthcare products Regulatory Agency, United Kingdom)
PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
CDSCO (Central Drugs Standard Control Organization, India)
Betadex is a type of Additives
Additives in the pharmaceutical API category refer to a group of chemical substances that are incorporated into pharmaceutical products to enhance their stability, functionality, or performance. These additives play a crucial role in ensuring the quality, safety, and efficacy of medications.
One common type of additive used in pharmaceuticals is preservatives. Preservatives are added to prevent microbial growth and maintain the integrity of the product throughout its shelf life. They help to safeguard against contamination and maintain the potency of the active pharmaceutical ingredient (API). Some commonly used preservatives include benzyl alcohol, phenol, and parabens.
Another important group of additives is antioxidants. Antioxidants are added to pharmaceutical formulations to prevent or delay the oxidation of APIs, which can lead to degradation and loss of potency. Examples of antioxidants commonly used in pharmaceuticals include ascorbic acid (vitamin C) and tocopherols (vitamin E).
In addition to preservatives and antioxidants, other additives like flavorings, colorants, and sweeteners may be incorporated into pharmaceutical products to improve their palatability and patient acceptability.
It is crucial to note that the use of additives in pharmaceuticals is strictly regulated by health authorities to ensure their safety and efficacy. Manufacturers must comply with stringent quality control standards and guidelines to guarantee the proper use and appropriate levels of additives in pharmaceutical products.
Overall, additives play a vital role in the pharmaceutical industry by enhancing the stability, functionality, and patient acceptability of medications. Their careful selection and incorporation contribute to the overall quality and effectiveness of pharmaceutical products.
Betadex manufacturers | traders | suppliers
We have 1 companies offering Betadexproduced in 1 different countries.
Get in contact with the supplier of your choice:
- Aurora Industry Co., Ltd from China, product country of originChina
Let the supplier know whether you are looking for a product with a specificmonograph such as EP (Ph. Eur.), USP, JP, BP or another quality.Or, whether you are looking for hydrochloride (HCl), anhydricum, base, micronisatum or a specificpurity.
You can use the filters to find high-quality suppliers.For example, you can selectGMP, FDA or ISO certified suppliers. Visit ourFAQ page or use the chat box in the corner to get more information about Pharmaoffer.
We are showing synonyms/CAS number in order to help you connect with the right supplier.However, a synonym/CAS number doesn't always mean that it is exactly the same product.Always contact the supplier in order to verify the specifications of their products.
