HPMC capsule is an empty pharmaceutical capsule composed of hypromellose and water. The standards for manufacturing Empty HPMC Capsules can vary according to the requirements of the region or country, the following are some common standards:
American Standards: Meet the standards of the United States Pharmacopoeia (USP), including specifications, dry weight, length, diameter, weight loss, solubility, microbial quality, insoluble, and capsule rupture strength.
European Standards: Conform to the standards of the European Pharmacopoeia (EP), including indicators such as appearance, size, dry weight, moisture, sterility, and capsule rupture strength.
Chinese Standards: Meet the standards of the Chinese Pharmacopoeia (CP), including appearance, size, dry weight, moisture, sterility, capsule rupture strength and other indicators.
Regardless of the regional standard, the process of manufacturing Empty HPMC Capsules needs to follow strict GMP standards. This includes the selection of raw materials to control the production process to ensure the quality and safety of products. Generally, the process of manufacturing Empty HPMC Capsules involves the following steps:
Raw material selection: Choose high-quality hypromellose and water that meet the standards.
Production process: Mix the raw materials to form the capsule liquid; go through membrane filtration, sterilization, drying and other steps to make the capsule shell; pair the shell and the inner shell to form a hollow capsule.
Quality Control: The finished hollow capsules are inspected for indicators such as appearance, size, dry weight, moisture, sterility, capsule rupture strength, etc., to ensure compliance with standard requirements.
In short, the standard for manufacturing Empty HPMC Capsules depends on the requirements of the region or country, but no matter what the standard is, it is necessary to follow strict GMP standards to ensure product quality and safety.