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PHR1420

Doxylamine Succinate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Doxylamine succinate salt

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About This Item

Empirical Formula (Hill Notation):
C17H22N2O · C4H6O4
CAS Number:
562-10-7
Molecular Weight:
388.46
NACRES:
NA.24
PubChem Substance ID:
329823390
UNSPSC Code:
41116107
EC Number:
209-228-7
MDL number:
MFCD00056168
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Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. Y0001562, traceable to USP 1227006

API family

doxylamine

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

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)

InChI key

KBAUFVUYFNWQFM-UHFFFAOYSA-N

Gene Information

human ... HRH1(3269)

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.
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.

Analysis Note

These secondary standards offer multi-traceability to the USP and EP 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.
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.

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pictograms

Exclamation mark
GHS07

signalword

Warning

Hazard Classifications

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

target_organs

Respiratory system

Storage Class

11 - Combustible Solids

wgk

WGK 2

flash_point_f

Not applicable

flash_point_c

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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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)
Liquid chromatographic determination of amines in complex cough-cold formulations
Fong GW and Mark EW
International Journal of Pharmaceutics, 53(2), 91-97 (1989)
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)
View All Related Papers

Global Trade Item Number

SKUGTIN
PHR1420-1G04061834416371