Question

Maximum limit of iron used in gelatin for manufacturing Soft Gelatin capsule shell should not exceed

• A. 15 PPM
• B. 20 PPM
• C. 25 PPM
• D. 50 PPM

Hint:

Maintaining low heavy metal content, including iron, in gelatin ensures the physical integrity and chemical stability of soft gelatin capsules.

Answer 1

The Correct Option is A

Gelatin is a key raw material used in the manufacture of soft gelatin capsules, acting as the primary film-forming agent. The quality and purity of gelatin are critical to ensure the safety and stability of the final pharmaceutical product. One important parameter is the maximum allowable limit of heavy metals such as iron in gelatin. Iron content in gelatin should be kept minimal to avoid oxidative degradation and discoloration of the capsule shells, which can affect both the appearance and shelf life of the product. According to pharmacopeial standards and pharmaceutical guidelines, the maximum permissible limit of iron in gelatin used for soft gelatin capsules is typically set at 15 parts per million (PPM). Exceeding this limit can lead to catalytic oxidation of capsule contents and impact the mechanical properties of the shell. Therefore, manufacturers strictly monitor and control iron content during gelatin processing and quality testing.