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PHR1658

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Dimenhydrinate

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Dimenhydrinate, DMH, N-(2-Diphenylmethoxyethyl)-N,N-dimethylammonium 8-chlorotheophyllinate
Empirical Formula (Hill Notation):
C17H21NO · C7H7ClN4O2
CAS Number:
523-87-5
Molecular Weight:
469.96
EC Number:
208-350-8
MDL number:
MFCD00054265
UNSPSC Code:
41116107
PubChem Substance ID:
329823536
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to Ph. Eur. D2000000
traceable to USP 1206006

API family

dimenhydrinate

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

CN1C(=O)N(C)c2nc(Cl)[nH]c2C1=O.CN(C)CCOC(c3ccccc3)c4ccccc4

InChI

1S/C17H21NO.C7H7ClN4O2/c1-18(2)13-14-19-17(15-9-5-3-6-10-15)16-11-7-4-8-12-16;1-11-4-3(9-6(8)10-4)5(13)12(2)7(11)14/h3-12,17H,13-14H2,1-2H3;1-2H3,(H,9,10)

InChI key

NFLLKCVHYJRNRH-UHFFFAOYSA-N

Gene Information

human ... HRH1(3269)

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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.
Dimenhydrinate, a diphenhydramine salt of 8-chlorotheophylline, exhibits antihistaminic activity, with antimuscarinic and sedative effects. It finds its major application as an antiemetic drug in the prevention and treatment of motion sickness.

Application

Dimenhydrinate may be used as a pharmaceutical reference standard for the determination of the analyte in traditional Chinese medicine and 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, 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 LRAC3017 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Recommended products

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

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Pictograms

Exclamation mark
GHS07

Signal Word

Warning

Hazard Statements

H302

Hazard Classifications

Acute Tox. 4 Oral

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

监管及禁止进口产品

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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Simultaneous determination of Dimenhydrinate, Cinnarizine and Cinnarizine impurity by TLC and HPLC chromatographic methods.
Ahmed AB, et al.
Bulletin of Faculty of Pharmacy, Cairo University , 55(1), 163-169 (2017)
Optimization and validation of a method for the determination of caffeine, 8-chlorotheophylline and diphenhydramine by isocratic high-performance liquid chromatography: Stress test for stability evaluation.
Barbas C, et al.
Journal of Chromatography A, 870(1-2), 97-103 (2000)
HPLC and GC?MS screening of Chinese proprietary medicine for undeclared therapeutic substances.
Liu SY, et al.
Journal of Pharmaceutical and Biomedical Analysis, 24(5-6), 983-992 (2001)

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