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PHR1777

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Orphenadrine Citrate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Orphenadrine citrate salt, β-Dimethylaminoethyl 2-methylbenzhydryl ether citrate salt, o-Methyldiphenhydramine citrate salt

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About This Item

Empirical Formula (Hill Notation):
C18H23NO · C6H8O7
CAS Number:
Molecular Weight:
461.50
EC Number:
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

agency

traceable to Ph. Eur. Y0000101
traceable to USP 1479009

API family

orphenadrine

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

OC(=O)CC(CC(O)=O)C(O)=O.CN(C)CCOC(c1ccccc1)c2ccccc2C

InChI

1S/C18H23NO.C6H8O6/c1-15-9-7-8-12-17(15)18(20-14-13-19(2)3)16-10-5-4-6-11-16;7-4(8)1-3(6(11)12)2-5(9)10/h4-12,18H,13-14H2,1-3H3;3H,1-2H2,(H,7,8)(H,9,10)(H,11,12)

InChI key

XLSFUJUURNFSCL-UHFFFAOYSA-N

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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.
Orphenadrine Citrate is an analog of diphenhydramine antihistamine drug. It operates as a centrally acting skeletal muscle relaxant and effectively serves to relieve painful skeletal muscle spasms by working as an analgesics.

Application

Orphenadrine Citrate may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography as well as spectrophotometry 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.

Biochem/physiol Actions

Muscarinic receptor antagonist; H1 histamine receptor antagonist; muscle relaxant. Orphenadrine has also been reported to inhibit the noradrenergic transporter and to block the NMDA receptor ion channel.

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 LRAA8433 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Skull and crossbones

signalword

Danger

hcodes

Hazard Classifications

Acute Tox. 3 Oral

wgk_germany

WGK 3

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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Spectrophotometric determination of phenylephrine HCl and orphenadrine citrate in pure and in dosage forms.
Shama SA
Journal of Pharmaceutical and Biomedical Analysis, 30(4), 1385-1392 (2002)
Development of a capillary electrophoresis method for the determination of orphenadrine citrate in tablets in the presence of paracetamol.
Haj-Ali DN and Hamdan II
Saudi Pharmaceutical Journal : SPJ : The Official Publication of the Saudi Pharmaceutical Society, 18(4), 233-237 (2010)
Khaled Darwish et al.
Chemical & pharmaceutical bulletin, 60(11), 1426-1436 (2012-11-06)
New, simple, rapid and precise reversed-phase high-performance liquid chromatographic method was developed for the simultaneous determination of orphenadrine citrate, caffeine and aspirin in presence of aspirin degradation products, orphenadrine citrate and caffeine process related impurities, and excipients. Good resolution and

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