Citric Acid Anhydrous as an Active Pharmaceutical Ingredient (API)

Jungbunzlauer supplies a wide range of industries with its natural and sustainable ingredients, including the pharmaceutical industry. Committed to our stringent quality standards, our portfolio of active pharmaceutical ingredients and excipients meets the highest quality standards. Jungbunzlauer's products are versatile and can provide a comprehensive solution for the entire pharmaceutical industry.

Jungbunzlauer manufactures citric acid anhydrous with a GMP certificate, type II US DMF, and a CEP. Citric acid, primarily used in its anhydrous form, possesses excellent pH regulation and buffering properties, making it suitable for various drug applications. Citric acid anhydrous is commonly used in antacids and laxative medicinal products as an API.

Citric acid as an antacid

• In antacids, citric acid is used as an active ingredient to alleviate heartburn, acid indigestion, and sour stomach. Antacids work by increasing the pH of the stomach through the reduction of hydrochloric acid concentration. Other common active ingredients in antacids are sodium bicarbonate and acetylsalicylic acid (ASA), which helps with pain relief. When dissolved in water, citric acid and sodium bicarbonate react to form sodium citrate, water, and carbon dioxide, enhancing the absorption and action of ASA.

Citric acid as a laxative

• Citric acid is widely employed in laxative applications. It is often combined with other ingredients such as magnesium oxide and sodium picosulfate in oral solutions for bowel cleansing before colonoscopies or surgeries. The osmotic properties of citric acid stimulate bowel movements and increase water content in the intestines, aiding in the relief of constipation. The efficacy and safety of citric acid make it a popular choice for short-term relief of constipation and bowel cleansing procedures. ?

Citric acid as an excipient or key starting material

• Citric acid is commonly used as excipient in addition to its role as an API, serving as a buffer, chelating agent, effervescent agent, or in lyophilisation processes. Jungbunzlauer adhered to cGMP standards beyond IPEC and can offer supportive data to facilitate the use of citric acid anhydrous as an excipient in your drug product. This includes compliance with elemental impurities according to ICH Q3D, stability data following ICH guidelines, and nitrosamine risk assessments, among others. Additionally, Jungbunzlauer’s citric acid anhydrous serves as a GMP key starting material in the manufacturing process of other active ingredients.

?Citric acid granulations

• Citric acid anhydrous is available in various granulations to meet the specific needs of our customers. Jungbunzlauer offers standard broad profile, as well as fine and coarse granulations. All types of citric acid anhydrous exhibit high solubility and meet Ph.Eur. and USP quality standards, accompanied by a GMP certificate, a CEP, and a US DMF.

In addition to citric acid anhydrous, Jungbunzlauer’s current API portfolio?includes trisodium citrate dihydrate, potassium citrate monohydrate, and magnesium citrate anhydrous. These APIs can be supplied with a type II US DMF and/or CEP to facilitate drug registrations in the USA, Europe, and other regions, meeting the respective monographs (USP, Ph.Eur.). Furthermore, we offer GMP grade excipients (Excipient+) to ensure compliance with the highest pharmaceutical standards.