(2S)-HYDROXY(PHENYL)ACETIC ACID (2R)-N-BENZYL-1-(4-METHOXYPHENYL)PROPAN-2-AMINE (1:1) (SALT)

(2S)-HYDROXY(PHENYL)ACETIC ACID (2R)-N-BENZYL-1-(4-METHOXYPHENYL)PROPAN-2-AMINE (1:1) (SALT) is the industry‑standard form in which the enantiopure amine is traded, stored, and qualified for GMP synthesis of formoterol fumarate and arformoterol tartrate. By neutralizing (2S)-HYDROXY(PHENYL)ACETIC ACID (2R)-N-BENZYL-1-(4-METHOXYPHENYL)PROPAN-2-AMINE (1:1) (SALT) with aqueous base immediately before the coupling reaction, the free (2R)‑amine is generated in quantitative yield and without racemization. The use of (2S)-HYDROXY(PHENYL)ACETIC ACID (2R)-N-BENZYL-1-(4-METHOXYPHENYL)PROPAN-2-AMINE (1:1) (SALT) as the input material simplifies the regulatory filing, as the mandelic acid content and counterion stoichiometry are well‑defined and the salt’s stability is comprehensively documented. Cosperpharm ensures that the diastereomeric purity of (2S)-HYDROXY(PHENYL)ACETIC ACID (2R)-N-BENZYL-1-(4-METHOXYPHENYL)PROPAN-2-AMINE (1:1) (SALT) exceeds 99.5% d.e., giving confidence that the final API will meet the stringent chiral purity specifications of the USP and Ph. Eur. monographs.

Product Parameters

Product Advantages

1.Pre‑Resolved Chiral Building Block – Bypass the resolution step entirely; this salt gives you the correct (2R)‑amine directly.

2.Crystalline and Non‑Hygroscopic – Unlike the free base oil, this salt flows freely, weighs accurately, and does not form carbonates.

3.>99.5% d.e. Guaranteed – Diastereomeric purity is verified by a stability‑indicating HPLC method, with typical results >99.8% d.e.

4.Simple Activation – A mild base wash (e.g., saturated NaHCO₃) liberates the free amine quantitatively in biphasic conditions; no loss of e.e. is observed.

5.Regulatory‑Friendly Documentation – The well‑defined stoichiometry and impurity profile simplify the starting material justification in ANDA and NDA modules.

FAQ

Q: Can the mandelic acid be recovered after neutralization?

A: Yes, the aqueous bicarbonate layer contains sodium mandelate. Acidification with HCl precipitates (S)‑mandelic acid, which can be filtered and reused.

Q: Is this salt directly usable without neutralization?

A: No, the amine must be in its free base form to act as a nucleophile in the epoxide opening reaction. The mandelate counterion would otherwise form an ester or interfere.

Product Quality Assurance

Cosperpharm’s quality system ensures that every batch of (2S)-HYDROXY(PHENYL)ACETIC ACID (2R)-N-BENZYL-1-(4-METHOXYPHENYL)PROPAN-2-AMINE (1:1) (SALT) conforms to the following: diastereomeric purity by chiral HPLC (≥99.5% d.e.), achiral HPLC purity (≥99.0%), specific optical rotation, melting point, mandelic acid content (within 98–102% of theoretical), and residual solvents. A full Certificate of Analysis, SDS, and structure‑confirmatory spectra are supplied. We conduct ongoing stability studies per ICH Q1A and can provide data packages to support regulatory submissions.

Contact Us

To secure your inventory of this essential formoterol side‑chain salt, or to discuss the specifications needed for your specific regulatory market, contact the Cosperpharm supply management team — we’ll prepare a detailed quotation and arrange for a retained sample to be sent directly to your analytical lab.