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Key Documents

PHR1420

Supelco

Doxylamine Succinate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonyme(s) :

Doxylamine succinate salt

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About This Item

Formule empirique (notation de Hill):
C17H22N2O · C4H6O4
Numéro CAS:
Poids moléculaire :
388.46
Numéro CE :
Numéro MDL:
Code UNSPSC :
41116107
ID de substance PubChem :
Nomenclature NACRES :
NA.24

Qualité

certified reference material
pharmaceutical secondary standard

Niveau de qualité

Agence

traceable to Ph. Eur. Y0001562
traceable to USP 1227006

Famille d'API

doxylamine

CofA (certificat d'analyse)

current certificate can be downloaded

Technique(s)

HPLC: suitable
gas chromatography (GC): suitable

Application(s)

pharmaceutical (small molecule)

Format

neat

Température de stockage

2-30°C

Chaîne SMILES 

OC(=O)CCC(O)=O.CN(C)CCOC(C)(c1ccccc1)c2ccccn2

InChI

1S/C17H22N2O.C4H6O4/c1-17(20-14-13-19(2)3,15-9-5-4-6-10-15)16-11-7-8-12-18-16;5-3(6)1-2-4(7)8/h4-12H,13-14H2,1-3H3;1-2H2,(H,5,6)(H,7,8)

Clé InChI

KBAUFVUYFNWQFM-UHFFFAOYSA-N

Informations sur le gène

human ... HRH1(3269)

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Description générale

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.
Doxylamine succinate is an antihistaminic drug generally employed for the prevention of morning sickness in pregnant women.

Application

Doxylamine Succinate may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by various chromatography techniques.
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.

Remarque sur l'analyse

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

Autres remarques

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.

Note de bas de page

To see an example of a Certificate of Analysis for this material enter LRAC3445 in the slot below. This is an example certificate only and may not be the lot that you receive.

Pictogrammes

Exclamation mark

Mention d'avertissement

Warning

Mentions de danger

Classification des risques

Acute Tox. 4 Dermal - Acute Tox. 4 Inhalation - Acute Tox. 4 Oral - STOT SE 3

Organes cibles

Respiratory system

Code de la classe de stockage

11 - Combustible Solids

Classe de danger pour l'eau (WGK)

WGK 2

Point d'éclair (°F)

Not applicable

Point d'éclair (°C)

Not applicable


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Certificats d'analyse (COA)

Lot/Batch Number

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Consulter la Bibliothèque de documents

Development and Validation of a Rapid Chemometrics Assisted RP-HPLC with PDA Detection Method for the Simultaneous Estimation of Pyridoxine HCl and Doxylamine Succinate in Bulk and Pharmaceutical Dosage Form
Giriraj P and Sivakkumar T
Chromatography Research International, 2014(2), 91-97 (2014)
Formulation and evaluation of orodispersible tablet of taste masked doxylamine succinate using ion exchange resin
Puttewar TY, et al.
Journal of King Saud University - Science, 22(4), 229-240 (2010)
Liquid chromatographic determination of amines in complex cough-cold formulations
Fong GW and Mark EW
International Journal of Pharmaceutics, 53(2), 91-97 (1989)
Analysis of pharmaceutical preparations containing antihistamine drugs by micellar liquid chromatography
Martinez-Algaba C, et al.
Journal of Pharmaceutical and Biomedical Analysis, 40(2), 312-321 (2006)
Phillip Hasemann et al.
Electrophoresis, 28(11), 1779-1787 (2007-04-24)
An MEKC method was developed in order to separate a cold medicine formulation containing acetaminophen, ephedrine sulfate, doxylamine succinate, and dextromethorphan hydrobromide as active pharmaceutical ingredients. Because of their similar physical and chemical properties, it was a challenge to separate

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