Complaint
Pancreatic enzymes, also known as pancreases or pancrelipase and pancreatin, are commercial mixtures of amylase, lipase, and protease.They are used to treat malabsorption syndrome due to certain pancreatic problems.These pancreatic problems may be due to cystic fibrosis, surgical removal of the pancreas, long term pancreatitis, pancreatic cancer, or MODY 5, among others.The preparation is taken by mouth.
Common side effects include vomiting, abdominal pain, constipation, and diarrhea.Other side effects include perianal irritation and high blood uric acid.The enzymes are from pigs.Use is believed to be safe during pregnancy.The components are digestive enzymes similar to those normally produced by the human pancreas.They help the person digest fats, starches, and proteins.
Pancreatic enzymes have been used as medications since at least the 1800s. They are on the World Health Organization's List of Essential Medicines.In 2020, it was the 262nd most commonly prescribed medication in the United States, with more than 1 million prescriptions.
Technical Data Sheet
| Item | Specification |
| General Information | |
| Products Name | Pancreatin |
| Appearance | Off white to light yellow Fine Powder |
| Identification | Conform with standard |
| Odor&Taste | Characteristic |
| Loss on Drying | ≤5.0% |
| Ash | ≤5.0% |
| Particle Size | NLT 95% Pass 80 Mesh |
| Chemical Control | |
| Total Heavy Metals | ≤10.0ppm |
| Lead(Pb) | ≤ 0.5ppm |
| Arsenic(As) | ≤ 0.5ppm |
| Cadmium(Cd) | ≤ 0.1pm |
| Mercury(Hg) | ≤0.5ppm |
| Pesticide Residue | Meet USP |
| Microbial Control | |
| Total Plate Count | ≤10,000cfu/g |
| Yeast&Molds | ≤1,000cfu/g |
| E.Coli | Negative |
| Salmonella | Negative |
| Salmonella sp. | Negative |
| Packing and Storage | |
| Packing | Packing in paper-drums and double food-grade PE bag inside. 25Kg/Drum |
| Storage | Store in a well-closed container away from moisture and direct sunlight, room temperature. |
| Shelf Life | 3 years if sealed and stored properly. |
