99% コレスチラミン API GMP 製造業者

What is Cholestyramine API used for in pharmaceutical manufacturing?

Cholestyramine API is the active ingredient in oral powder for suspension formulations used for two primary indications: (1) reduction of elevated serum LDL‑cholesterol in primary hyperlipidemia (as monotherapy or adjunct to statins), and (2) relief of pruritus associated with partial biliary obstruction, primary biliary cholangitis, and other cholestatic liver diseases. It is also used off‑label for bile acid malabsorption and diarrhea, and as part of the treatment of digitalis glycoside toxicity (delayed absorption).

Is Cholestyramine API manufactured under cGMP?

Absolutely. Our facility is cGMP‑certified (Chinese NMPA) with dedicated lines for polymer synthesis, milling, and blending. Unlike chemical catalogs that sell “industrial grade,” our API meets pharmaceutical monographs. We do not supply non‑GMP material for human use.

Can compounding pharmacies legally use Cholestyramine API?

はい。

What is the stability of Cholestyramine API and compounded suspensions?

Our API is stable for 36 months when stored in tightly sealed, moisture‑proof containers at 15–25°C, protected from humidity. The resin is hygroscopic – exposure to open air will increase moisture content and may affect flow properties. For extemporaneous oral suspensions (mixed with water, juice, or simple syrup), the beyond‑use date (BUD) is typically 14 days refrigerated (2–8°C) based on USP general chapter <795>. In‑house stability data for specific suspending vehicles is available on request.

What is your MOQ and lead time for commercial orders?

The standard MOQ is 25 kg for R&D or clinical trial material and 100 kg for commercial supply. For bulk orders (metric tons), lead time is 1–3 weeks after order confirmation. We maintain a safety stock of 2–3 metric tons for urgent requirements – please inquire.

Do you offer custom particle size or milling?

いいえ。

What is the mechanism of action of Cholestyramine?

Cholestyramine binds bile acids in the intestinal lumen via anion exchange. Bound bile acids are excreted in feces, thereby reducing their return to the liver via enterohepatic circulation. The liver compensates by converting more cholesterol into bile acids, thereby upregulating LDL‑receptors on hepatocytes and increasing clearance of LDL‑cholesterol from the blood. The reduction in circulating bile acids also explains the antipruritic effect – lower bile acid concentrations in skin and serum correlate with symptom relief.

What impurity profile should I expect?

For a polymer, “impurities” primarily consist of residual monomers and degradation products. Our in‑house specification limits residual styrene to ≤ 100 ppm and residual divinylbenzene to ≤ 100 ppm (ICH Q3C Class 2 solvents). We also test for heavy metals (≤20 ppm), organic volatile impurities, and microbial contaminants. Total organic impurities (non‑volatile extractables) are controlled via process validation. Full extractables and leachables data are included in the DMF.

Is Cholestyramine still patent‑protected in major markets?

Basic composition patents for cholestyramine resin expired decades ago. Questran® and other branded products are off‑patent. The FDA Orange Book lists no unexpired exclusivities for cholestyramine powder for suspension. However, some formulation patents (e.g., specific suspending systems, taste‑masked preparations) may exist. Buyers are responsible for freedom‑to‑operate analysis.

How do I get a sample for formulation development?

Request a sample via the contact form. We ship 1 g to 10 g samples (sufficient for analytical testing and small‑batch suspension preparation) within 5–7 business days under a material transfer agreement. Samples are free for qualified pharmaceutical manufacturers and compounding pharmacies; you pay shipping.

What excipients are compatible with Cholestyramine API?

The API is compatible with common suspending agents (xanthan gum, carboxymethylcellulose sodium, microcrystalline cellulose), sweeteners (sucrose, aspartame, sucralose, saccharin sodium), flavorings (fruit flavors, citrus oils), and preservatives (methylparaben, propylparaben, sodium benzoate). Avoid high‑humidity packaging that can cause caking. Excipient compatibility data is available upon request.

Do you support veterinary applications?

Yes. Cholestyramine is used in veterinary medicine for lipid disorders in dogs, and for pruritus in cholestatic cats and dogs. Our API can be supplied with veterinary‑specific documentation. Please inquire.