Description

(-)-Pseudoephedrine CAS NO 321-97-1 is a stereoisomer of ephedrine, widely recognized for its potent decongestant properties. This high-purity active pharmaceutical ingredient (API) is critical for ensuring the efficacy and safety of formulated pharmaceutical products. It is primarily required by manufacturers in the pharmaceutical industry for the production of prescription and over-the-counter (OTC) cold, flu, and allergy medications.

Application

• Primary Pharmaceutical Ingredient: Key API in oral decongestant tablets, capsules, and liquid formulations for relieving nasal and sinus congestion.
• Combination Cold & Flu Medications: Used in multi-symptom relief products combined with analgesics, antihistamines, or antitussives.
• Veterinary Pharmaceuticals: Employed in certain veterinary medicinal products for respiratory conditions in animals.
• Reference Standard: Serves as a high-purity analytical standard in quality control laboratories for method development and validation.
• Chemical Synthesis Intermediate: Utilized as a chiral building block or precursor in the synthesis of more complex pharmaceutical compounds.
• Research & Development: Used in pharmacological studies and clinical research related to adrenergic receptors and nasal decongestion.

Basic Information

Product Name	(-)-Pseudoephedrine
CAS No.	321-97-1
Molecular Formula	C10H15NO
Molecular Weight	165.23 g/mol
Synonyms	(-)-Pseudoephedrine; (1S,2S)-Pseudoephedrine; l-Pseudoephedrine; (1S,2S)-2-Methylamino-1-phenylpropan-1-ol; d-ψ-Ephedrine; S,S-Pseudoephedrine; Sudafed (brand name active ingredient); Isoephedrine
EINECS	206-283-3

Quality Control

Our (-)-Pseudoephedrine is manufactured under strict quality management systems. We provide material that meets or exceeds relevant pharmacopoeial standards, including USP (United States Pharmacopeia) and EP (European Pharmacopoeia) monographs where applicable. Every batch undergoes comprehensive analytical testing, including identity, purity, and impurity profile determination. Certificates of Analysis (COA) documenting all test results are available upon request to ensure full traceability and compliance for your regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F), in a dry, well-ventilated area. Keep the container securely sealed when not in use to protect from moisture.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Specific Rotation	-50.0° to -53.0° (c=5 in H2O)
Water (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Heavy Metals	≤ 20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.