Colestyramine, also known as Cholestyramine, is a non-absorbed bile acid sequestrant and pharmaceutical active ingredient. It is an anion-exchange resin that binds bile acids in the gastrointestinal tract and prevents their normal reabsorption.
Colestyramine is a polymeric pharmaceutical material, rather than a conventional low-molecular-weight crystalline API. Therefore, it does not have one fixed molecular weight or a simple molecular formula.
Colestyramine is supplied as a pharmaceutical-grade active ingredient for formulation and pharmaceutical manufacturing applications. Its quality is evaluated using tests appropriate for anion-exchange resins, including identification, moisture, chloride content, particle-size characteristics and ion-exchange capacity.
Colestyramine is used as a bile acid sequestrant. It binds bile acids within the gastrointestinal tract, reducing their reabsorption and increasing their elimination. This mechanism contributes to lowering circulating LDL cholesterol.
It may also be used in pharmaceutical preparations for certain bile-acid-related gastrointestinal conditions, depending on the approved indication of the finished formulation.
Colestyramine quality testing should be performed using suitable analytical procedures for the specific grade and applicable pharmacopoeial requirements.
Testing may include:
Store Colestyramine in a tightly closed container under suitable controlled conditions. Protect from excessive moisture and contamination. Follow the current product specification and SDS for storage, handling and packaging requirements.
Colestyramine can be supplied to qualified pharmaceutical manufacturers, formulation companies, distributors and other pharmaceutical industry customers. CoA, SDS, specifications and technical documentation 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 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | ≤ 0.5% |
| Melting Point | 150°C – 154°C |