Colestipol is a non-absorbed, basic anion-exchange resin used as a pharmaceutical active ingredient for lowering elevated cholesterol levels. It binds bile acids in the gastrointestinal tract, preventing their reabsorption and promoting their elimination from the body.
Colestipol is a high-molecular-weight, water-insoluble polymeric material. Unlike conventional small-molecule APIs, it does not have a single defined molecular formula or molecular weight because it consists of a cross-linked polymeric resin.
Colestipol is supplied as a pharmaceutical-grade active ingredient for formulation and pharmaceutical manufacturing applications. Its quality is evaluated using appropriate physicochemical and performance-based tests suitable for an ion-exchange resin.
Colestipol is used as a bile acid sequestrant in pharmaceutical formulations for managing elevated cholesterol. It works locally in the gastrointestinal tract by binding bile acids and reducing their reabsorption.
The resulting increased elimination of bile acids causes the liver to use cholesterol to synthesize additional bile acids, thereby contributing to a reduction in circulating LDL cholesterol.
Colestipol quality testing may include identification, chloride content, moisture or loss on drying, particle-size distribution, ion-exchange capacity and other applicable physicochemical characteristics.
Because Colestipol is a polymeric ion-exchange resin, its specifications are different from those of conventional crystalline small-molecule APIs. Numerical specifications should therefore be taken from the current approved product specification or applicable pharmacopoeial monograph.
Store Colestipol in a tightly closed container under suitable controlled conditions. Protect the material from excessive moisture and contamination. Follow the manufacturer's specification and SDS for appropriate handling, storage and packaging requirements.
Colestipol can be supplied to qualified pharmaceutical manufacturers, formulation companies, distributors and other industry customers. Product documentation, specifications, CoA and SDS can be provided according to applicable requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| pH (1% Solution) | 2.0 – 4.0 |
| Water Content | NMT 0.5% |
| Melting Point | 150°C – 154°C |