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PHR1538

Supelco

Pseudoephedrine hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):
d-Pseudoephedrine hydrochloride, (+)-ψ-Ephedrine hydrochloride, (1S,2S)-2-Methylamino-1-phenylpropanol hydrochloride, d-Isoephedrine hydrochloride, (+)-Pseudoephedrine hydrochloride
Linear Formula:
C6H5CH[CH(NHCH3)CH3]OH·HCl
CAS Number:
Molecular Weight:
201.69
Beilstein:
3915112
EC Number:
MDL number:
PubChem Substance ID:

Quality Level

grade

certified reference material
pharmaceutical secondary standard

CofA

current certificate can be downloaded

packaging

pkg of 250 mg

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

mp

185-188 °C (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

pharmacopeia traceability

traceable to PhEur P3850000
traceable to USP 1581005

storage temp.

2-30°C

SMILES string

Cl.CN[C@@H](C)[C@@H](O)c1ccccc1

InChI

1S/C10H15NO.ClH/c1-8(11-2)10(12)9-6-4-3-5-7-9;/h3-8,10-12H,1-2H3;1H/t8-,10+;/m0./s1

InChI key

BALXUFOVQVENIU-KXNXZCPBSA-N

General description

Pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards

Application

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.
Pseudoephedrine hydrochloride may be used as a reference standard for the determination of the analyte in pharmaceutical formulations by high-performance liquid chromatography.

Biochem/physiol Actions

Non-selective adrenergic agonist; decongestant

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC2625 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Exclamation mark

Signal Word

Warning

Hazard Statements

Hazard Classifications

Acute Tox. 4 Oral - STOT SE 3

Target Organs

Central nervous system

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

T G Altuntas et al.
Journal of pharmaceutical and biomedical analysis, 17(1), 103-109 (1998-06-03)
In this study, fourth derivative spectrophotometry and high performance liquid chromatography (HPLC) have been used and described for the quantitative determination of acrivastine (I) and pseudoephedrine hydrochloride (II) in their pharmaceutical capsules form (Duact). In the former method, d4A/d gamma
Full and fractionated experimental designs for robustness testing in the high-performance liquid chromatographic analysis of codeine phosphate, pseudoephedrine hydrochloride and chlorpheniramine maleate in a pharmaceutical preparation.
Ragonese R, et al.
Journal of Chromatography A, 870(1-2), 45-51 (2000)

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