Pharmaceutical Grade Vitamin C VC Powder Raw Material for Preparation with Cosmetic Grade Filing Qualification, Total Content Above 99%

Vitamin C Pharmaceutical Grade (Ascorbic Acid) CP Edition Pharmacopoeia Quality Standards

Chinese Pharmacopoeia Quality Standards for Pharmaceutical Grade Vitamin C Raw Material:

Vitamin C (Ascorbic Acid), also known as ascorbic acid, is a water-soluble vitamin widely used in pharmaceuticals, food, health products, and other industries. As a pharmaceutical raw material, Vitamin C must strictly comply with the quality standards of the Chinese Pharmacopoeia (CP Edition) to ensure its safety and efficacy, especially in the pharmaceutical industry.

Vitamin C Pharmaceutical Grade CP Edition Pharmacopoeia Quality Standards

1. Appearance

Vitamin C is a white or almost white crystalline powder or crystals with a weak acidic taste. Its cleanliness and color must meet pharmacopoeia requirements.

2. Solubility

Vitamin C is easily soluble in water, slightly soluble in ethanol, and almost insoluble in chloroform. Its solubility characteristics are crucial for use in pharmaceutical preparations.

3. Identification

The pharmacopoeia requires identification of Vitamin C through the following methods:

- Ultraviolet absorption spectroscopy: Measure absorption peaks at wavelengths of 245 nm and 265 nm.

- Chemical reaction: Reacts with specific reagents to produce a yellow or dark brown solution.

4. Assay

The Vitamin C content is 99.0% to 100.5%, determined by titration to ensure the active ingredient content is within the standard range.

5. pH Value

The pH of an aqueous solution (10 g/L) is 2.1 to 2.6. Controlling its acidity and alkalinity helps maintain the stability of Vitamin C and compatibility with drug formulations.

6. Loss on Drying

The loss on drying must not exceed 0.4%. This indicator reflects the content of moisture or volatile components in the product, ensuring product stability.

7. Residue on Ignition

The residue on ignition must not exceed 0.1%. This indicator is used to assess the level of inorganic impurities in the raw material.

8. Heavy Metal Content

Heavy metals (calculated as lead) must not exceed 10 ppm, detected by ICP-MS or chemical colorimetry to ensure drug safety.

9. Related Substances

Single impurities must not exceed 0.1%, and total impurities must not exceed 0.2%. Impurity control is tested by high-performance liquid chromatography (HPLC) to ensure drug purity.

10. Antioxidant Properties

The pharmacopoeia requires Vitamin C to have certain antioxidant capabilities, evaluated through its reducing properties to ensure stability in formulations.

11. Packaging and Storage

Vitamin C must be stored in a dry, cool place, protected from light and sealed to avoid high temperature and humidity affecting its chemical properties. It is recommended to use light-resistant packaging with aluminum foil lining.

Pharmaceutical Grade Vitamin C VC Powder Raw Material for Preparation with Cosmetic Grade Filing Qualification, Total Content Above 99%

As an important pharmaceutical raw material, the quality standards of Vitamin C directly affect the safety and efficacy of drugs. The Chinese Pharmacopoeia 2020 Edition strictly regulates Vitamin C in terms of appearance, solubility, content, impurities, and more.

Main products include:
Common excipients for topical preparations: Glycerin/Propylene Glycol, Vaseline/Lanolin, Laurocapram, Stearic Acid, Triethanolamine, Poloxamer 188/407, Polysorbate 80, Polyethylene Glycol Series, Solid Paraffin, Liquid Paraffin (Light/Heavy), Mixed Fatty Acid Glycerides, and other varieties.
Excipients for oral preparations: Honey/Sucrose, Lactose/Aspartame, Hydroxypropyl Beta-Cyclodextrin, Hydroxypropyl Methylcellulose, Methylcellulose, Ethylcellulose, Microcrystalline Cellulose, Povidone K30, Magnesium Stearate, Maltose/Saccharin Sodium/Sucralose/Tranexamic Acid/Stevioside, Gelatin, Pigment Lakes, Flavors, and other varieties.
Excipients for injections: (Endotoxin & Microbial Limit Requirements)
Cholesterol, Trehalose (Anhydrous/Dihydrate), Lecithin/Soybean Phospholipid, Polysorbate (for injection), Citric Acid/Sodium Citrate, Sodium Dihydrogen Phosphate/Dipotassium Hydrogen Phosphate, Lactose (for injection), Disodium Edetate (for injection)
Raw materials for topical disinfection and bacteriostasis:
Chlorhexidine Acetate, Chlorhexidine Gluconate Solution, Benzalkonium Bromide/Benzalkonium Chloride, Menthol/Peppermint Oil, Salicylic Acid/Sodium Benzoate, Vitamin E Oil, Dimethicone, Span 80/85, Methylparaben/Ethylparaben/Propylparaben/Sodium Methylparaben/Sodium Propylparaben, Tromethamine, Chlorobutanol, Dihydroxyaluminum Aminoacetate, etc.

Sterile Water for Injection, Silver Sulfadiazine, Vitamin A, Camphor, Borneol, Sodium Bicarbonate, Berberine, Pentoxyverine Citrate, Metformin, Artificial Bezoar, Paracetamol, Simple Syrup, Dexamethasone, Glycerin, Potassium Citrate, Chitosan, Calamine, Roxithromycin, Procaine
Also available for consultation: Food Grade, Extracts, Reagents, Intermediates, Cosmetic Raw Materials, Export Products.