As the name implies, pharmaceutical gelatin is used in the production of pharmaceutical products. Their uses: Some pharmaceutical products are produced directly, such as cod liver oil; while some are produced indirectly, such as hard capsules. It is used as a drug packaging. Pharmaceutical gelatin is an important fine chemical material with a wide range of applications. However, in the past, apart from the technical specifications of “gelatin” listed in the pharmacopoeia, there was no official standard for pharmaceutical gelatin.
In addition, the pharmacopoeia only specifies requirements for a single variety of gelatin, and the technical items and indicators are incomplete and cannot comprehensively reflect the actual scope of application. In order to standardize the production of hard capsules, the Ministry of Health developed the “Gelatin Capsule Standard” for the main raw material gelatin in 1988.
However, this standard only applied to the manufacture of hard capsules. As a pharmaceutical gelatin, there is no official standard to follow, therefore, both gelatin manufacturers and gelatin users are based on edible gelatin standards and some are based on the “capsule gelatin” standard established by the Ministry of Health in 1988.
Therefore, there was an urgent need for a unified pharmaceutical gelatin standard to regulate the then inconsistent production and use requirements.
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