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PHR1018

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Dextromethorphan HBr

certified reference material, pharmaceutical secondary standard

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Synonym(s):
Dextromethorphan hydrobromide monohydrate, (9S,13S,14S)-3-Methoxy-17-methylmorphinan hydrobromide
Empirical Formula (Hill Notation):
C18H25NO · HBr · H2O
CAS Number:
Molecular Weight:
370.32
Beilstein:
6453793
MDL number:
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.

Pictograms

Skull and crossbonesEnvironment

Signal Word

Danger

Hazard Statements

Hazard Classifications

Acute Tox. 3 Oral - Aquatic Chronic 2

Storage Class Code

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

WGK

WGK 2

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)

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T1503
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25G
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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)
G Nicholas Verne et al.
The journal of pain : official journal of the American Pain Society, 13(9), 901-909 (2012-09-11)
Irritable bowel syndrome (IBS) is a common gastrointestinal disorder in which the pathophysiological mechanisms of the pain and hypersensitivity are incompletely understood. IBS patients frequently complain of pain in body regions somatotopically distinct from the gut, suggesting involvement of central
Andreas Trojan et al.
Cancer chemotherapy and pharmacology, 71(2), 301-306 (2012-10-27)
Endoxifen serum concentrations seem to correlate with outcome in breast cancer (BC) patients. Concurrently, cytochrome P450 2D6 (CYP2D6) enzyme activity and dextromethorphan (DM) metabolism are deemed a surrogate marker for the formation of endoxifen. Here, we conducted a matched cohort
Shiou-Lan Chen et al.
Journal of neuroimmune pharmacology : the official journal of the Society on NeuroImmune Pharmacology, 7(4), 1025-1033 (2012-09-20)
Recent studies show that proinflammatory cytokines might be related to the development of opioid dependence (physiological, psychological, or both). In a double-blind, randomly stratified clinical trial investigating whether add-on dextromethorphan (60-120 mg/day) attenuated inflammation and the combined use of opioids

Protocols

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

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