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Merck
CN

PHR1420

琥珀酸多西拉敏

Pharmaceutical Secondary Standard; Certified Reference Material

别名:

多西拉敏 琥珀酸盐

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关于此项目

经验公式（希尔记法）:
C17H22N2O · C4H6O4
化学文摘社编号:
562-10-7
分子量:
388.46
NACRES:
NA.24
PubChem Substance ID:
329823390
UNSPSC Code:
41116107
EC Number:
209-228-7
MDL number:
MFCD00056168

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产品名称

琥珀酸多西拉敏, Pharmaceutical Secondary Standard; Certified Reference Material

InChI key

KBAUFVUYFNWQFM-UHFFFAOYSA-N

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)

SMILES string

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

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

Quality Level

300

Gene Information

human ... HRH1(3269)

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Analysis Note

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

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.

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.

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.

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

存储类别

11 - Combustible Solids

wgk

WGK 2

flash_point_f

Not applicable

flash_point_c

Not applicable

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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)
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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