Nortriptyline Suppliers & Bulk Manufacturers

Available Forms: white Fine / Crystel powder

Available Strengths: API 98% Purity in the standard Grade

Reference Brands:

Category: Active Pharmaceutical Ingredient

Nortriptyline hydrochloride API to Ph. Eur., BP or USP grade, a crystalline powder for manufacturers of nortriptyline capsules and oral solutions. Listed for formulators and API buyers needing DMF or CEP support.

Product Description:

Nortriptyline hydrochloride is the active pharmaceutical ingredient behind nortriptyline capsules and oral solutions. It is a secondary-amine tricyclic antidepressant and the main active metabolite of amitriptyline. The material is a white or almost white crystalline powder, sparingly soluble in water. Monographs exist in the European, British and United States pharmacopoeias. The 98% purity quoted on this listing should be read against the assay and related-substances limits of the monograph you work to.

Finished-dose makers mainly use the hydrochloride in hard capsules and oral solutions, with tablets in some markets. Because nortriptyline is a secondary amine, it can form an N-nitroso derivative. Regulators now expect a nitrosamine risk assessment covering the API route and the finished product, with confirmatory testing where a risk is found. Ask how residual solvents, elemental impurities and related substances are controlled. For capsule filling, particle size and bulk density affect flow and content uniformity, so agree a specification early.

Sourcing notes. Request a US DMF, a CEP from the EDQM or an open and closed-part ASMF, whichever your authority accepts. Each batch should come with a CoA to the named pharmacopoeia, plus the API site GMP certificate, the nitrosamine risk assessment and a residual solvent statement. Retest period and storage come from the maker's stability data: well-closed containers, protected from light, at controlled room temperature unless the data say otherwise. It usually ships in double polyethylene bags inside fibre or HDPE drums. State grade, quantity, particle size and documents in your enquiry.