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Includes: HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, Structure Elucidation Report (SER), and additional analytical data depending on the product.
4779-94-6Phenylephrine EP Impurity A
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| Catalogue No.: | VL115004 |
|---|---|
| CAS No.: | 4779-94-6 |
| Mol. Formula: | C8H12ClNO2 |
| Mol. Weight: | 189.64 g/mol |
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Additional information on CAS 4779-94-6
Parent drug
PhenylphrineIUPAC Name
(R)-3-(2-Amino-1-hydroxyethyl) phenol. HCl Salt.Pharmacopeial Synonyms
Norphenylephrine hydrochlorideSynonyms
3-(2-amino-1-hydroxyethyl)phenol hydrochloride;1-(3′-hydroxyphenyl)-2-amino-ethanol hydrochlorideSmiles
OC1=CC=CC([C@@H](O)CN)=C1.[H]ClInChI
InChI=1S/C8H11NO2.ClH/c9-5-8(11)6-2-1-3-7(10)4-6;/h1-4,8,10-11H,5,9H2;1H/t8-;/m0./s1Shipping Condition
Ambient TemperatureDescription
Phenylephrine EP Impurity A is an N-nitroso derivative of the secondary amine present in Phenylephrine, which is a highly characterized reference material that meets stringent regulatory standards set for nitrosamine compounds, including those set by USP, EMA, JP, and BP. This nitroso standard is essential for a variety of applications, such as analytical method development, method validation (AMV), and Quality Control (QC), particularly in the context of Phenylephrine production. It is suitable for use in both Abbreviated New Drug Applications (ANDA) and New Drug Applications (NDA). This nitrosamine standard helps establish detection limits, quantify impurity levels, and ensure trace nitroso impurities in pharmaceutical products remain within FDA and EMA safety limits. Phenylephrine EP Impurity A (CAS No: 4779-94-6) or Norphenylphrine HCl is the synthetic precursor and degradation product of Phenylephrine. Phenylephrine in combination with other drugs is used for symptomatic relief of cold and flu symptoms, nasal congestion, and sinusitis.
References
Abou Al-Alamein, Amal M., et al. Green HPTLC-Densitometric Approach for Simultaneous Determination and Impurity- Profiling of Ebastine and Phenylephrine Hydrochloride. Microchemical Journal, vol. 147, June 2019, pp. 1097 “102, https://doi.org/10.1016/j.microc.2019.04.043. Dou, Michal, et al. Drug-Excipient Compatibility Testing ”Identification and Characterization of Degradation Products of Phenylephrine in Several Pharmaceutical Formulations against the Common Cold. Journal of PharmaceutiRequest a Quote
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