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PHR1018

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Dextromethorphan HBr

certified reference material, pharmaceutical secondary standard

Synonym(s):

Dextromethorphan hydrobromide monohydrate, (9S,13S,14S)-3-Methoxy-17-methylmorphinan hydrobromide

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About This Item

Empirical Formula (Hill Notation):
C18H25NO · HBr · H2O
CAS Number:
Molecular Weight:
370.32
Beilstein/REAXYS Number:
6453793
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. D0740000
traceable to USP 1181007

API family

dextromethorphan

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

Br[H].[H]O[H].[H][C@]12CCCC[C@]13CCN(C)[C@H]2Cc4ccc(OC)cc34

InChI

1S/C18H25NO.BrH.H2O/c1-19-10-9-18-8-4-3-5-15(18)17(19)11-13-6-7-14(20-2)12-16(13)18;;/h6-7,12,15,17H,3-5,8-11H2,1-2H3;1H;1H2/t15-,17+,18+;;/m1../s1

InChI key

STTADZBLEUMJRG-IKNOHUQMSA-N

Gene Information

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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. Dextromethorphan HBr is a cough suppressant and a mucolytic agent, widely used in the treatment of various respiratory disorders such as for the relief of non-productive cough.

Application

Dextromethorphan HBr may be used pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using hydrophilic interaction liquid chromatographic technique and first-derivative spectrophotometry technique.
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 (PhEur) 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 LRAC0713 in the slot below. This is an example certificate only and may not be the lot that you receive.

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Skull and crossbonesEnvironment

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Danger

Hazard Classifications

Acute Tox. 3 Oral - Aquatic Chronic 2

Storage Class

6.1D - Non-combustible, acute toxic Cat.3 / toxic hazardous materials or hazardous materials causing chronic effects

wgk_germany

WGK 2

flash_point_f

Not applicable

flash_point_c

Not applicable


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Certificates of Analysis (COA)

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Spectrophotometric determination of pipazethate HCl and dextromethorphan HBr using potassium permanganate
Gouda E-FAA, et al.
International Journal of Biomedical Science : IJBS, 4(4), 294-294 (2008)
A new hydrophilic interaction liquid chromatographic (HILIC) procedure for the simultaneous determination of pseudoephedrine hydrochloride (PSH), diphenhydramine hydrochloride (DPH) and dextromethorphan hydrobromide (DXH) in cough-cold formulations.
Ali S M, et al.
Journal of Pharmaceutical and Biomedical Analysis, 43(1), 158-167 (2007)
Fixed drug eruption due to dextromethorphan with tolerance to other opioids.
G Davila-Fernández et al.
Journal of investigational allergology & clinical immunology, 23(4), 281-282 (2013-08-24)
K N Chi et al.
Cancer chemotherapy and pharmacology, 71(1), 237-244 (2012-10-16)
To assess the effect of abiraterone acetate plus prednisone on the pharmacokinetics of dextromethorphan HBr (CYP2D6 substrate) and theophylline (CYP1A2 substrate) in patients with metastatic castration-resistant prostate cancer (mCRPC). Men with progressive metastatic mCRPC who failed gonadotropin-releasing hormone therapy and
Muneaki Matsuo et al.
Pediatric neurology, 48(3), 200-205 (2013-02-20)
Acute encephalopathy with biphasic seizures and late reduced diffusion was recently established clinicoradiologically as an encephalopathy syndrome. The outcome of this encephalopathy is characterized by a low mortality rate and high incidence of neurologic sequelae. Although the exact pathogenesis of

Protocols

Silica gel G 254 plates are suitable for analysis of Dextromethorphan following the European pharmacopeia monograph.

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