Pharmaceutical Grade Vitamin E Oil VE Oil National Drug Standard Preparation Bulk API Pharmacopoeia Standard Sample 500ml Minimum Order

Vitamin E (chemically known as α-tocopherol) is an important fat-soluble vitamin widely used in health products and pharmaceuticals, particularly in antioxidants, skincare products, and some pharmaceutical preparations. According to the Chinese Pharmacopoeia 2020 edition, the quality standards for pharmaceutical-grade Vitamin E include strict requirements for appearance, content, impurities, solubility, etc., ensuring its safety and efficacy in medications.

1. Appearance and Identification

Pharmaceutical-grade Vitamin E should be a colorless or pale yellow transparent oily liquid with a characteristic odor. Generally, Vitamin E primarily consists of tocopherol (α-tocopherol) and possesses unique antioxidant properties. The pharmacopoeia requires that the appearance of Vitamin E meets the standards of being an impurity-free, transparent liquid. If in solid form, it should be a colorless or white crystalline powder.

2. Content Determination

The content of Vitamin E is a key quality indicator in the pharmacopoeia. According to CP standards, pharmaceutical-grade Vitamin E must have a content between 95.0% and 105.0% of the labeled amount. To accurately determine the content of Vitamin E, high-performance liquid chromatography (HPLC) or ultraviolet absorption methods are commonly used. Chromatography separates the components in the sample to precisely measure the content of α-tocopherol, ensuring its efficacy in pharmaceutical preparations.

3. Acid Value and Peroxide Value

The quality standards for Vitamin E also include requirements for acid value and peroxide value. The acid value reflects the fatty acid content in Vitamin E; an excessively high acid value may indicate hydrolysis or oxidation of the oil, affecting the quality and stability of Vitamin E. The CP stipulates that the acid value of pharmaceutical-grade Vitamin E should not exceed 5.0 mgKOH/g, and the peroxide value should not exceed 10 meq/kg. These requirements ensure that Vitamin E does not undergo excessive oxidation during long-term storage, maintaining its stability and safety.

4. Moisture Content

Moisture content is also an important quality indicator for pharmaceutical-grade Vitamin E. Excessive moisture may lead to oxidative degradation of Vitamin E, so moisture content must be strictly controlled during processing. According to pharmacopoeia standards, the moisture content of Vitamin E should not exceed 0.5% to ensure its effectiveness during use.

5. Heavy Metal Content

The requirements for heavy metal content in pharmaceutical-grade Vitamin E are extremely strict. According to the Pharmacopoeia, the total heavy metal content in Vitamin E must not exceed 10 ppm, and arsenic content must not exceed 2 ppm. This ensures the safety of Vitamin E in drugs and health products, preventing potential harm to human health from harmful substances.

6. Microbial Limits

Pharmaceutical-grade Vitamin E must also meet microbial limit requirements. To prevent microbial contamination, strict hygiene control measures are implemented during the preparation of Vitamin E. According to the pharmacopoeia, the microbial limits for Vitamin E should meet the requirements of being free from pathogenic bacteria and coliforms to ensure its safety during use.

Pharmaceutical Grade Vitamin E Oil VE Oil National Drug Standard Preparation Bulk API Pharmacopoeia Standard Sample 500ml Minimum Order

In Vitamin E preparations, the solubility, dispersibility, and stability of Vitamin E enable the resulting medications to have better bioavailability and a longer shelf life. In tablets and soft capsules, Vitamin E often needs to be combined with other excipients to ensure its full release and absorption in the medication.

Vitamin E (VE), also known as tocopherol, is an important fat-soluble antioxidant widely used in pharmaceuticals, health products, cosmetics, and other fields. Vitamin E has significant antioxidant effects, neutralizing free radicals and protecting cell membranes from oxidative damage. It plays a crucial role in maintaining immune function, delaying aging, and preventing cardiovascular diseases. According to the relevant standards of the Chinese Pharmacopoeia 2020 Edition (CP2020), the quality standards for pharmaceutical-grade Vitamin E are strictly regulated to ensure its safety and efficacy in the pharmaceutical and health sectors.