PHR2701

Dexmedetomidine Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Dexmedetomidine hydrochloride, (+)-Medetomidine hydrochloride, (S)-Medetomidine hydrochloride, 4-[(S)-α,2,3-Trimethylbenzyl]imidazole monohydrochloride, 5-[(1S)-1-(2,3-Dimethylphenyl)ethyl]-1H-imidazole hydrochloride
• Empirical Formula (Hill Notation): C₁₃H₁₆N₂ · HCl
• CAS Number: 145108-58-3
• Molecular Weight: 236.74
• UNSPSC Code: 41116107

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to USP 1179333
• API family: dexmedetomidine, medetomidine
• form: powder
• CofA: current certificate can be downloaded
• packaging: pkg of 500 mg
• storage temp.: 2-30°C
• InChI: 1S/C13H16N2.ClH/c1-9-5-4-6-12(10(9)2)11(3)13-7-14-8-15-13;/h4-8,11H,1-3H3,(H,14,15);1H/t11-;/m0./s1
• InChI key: VPNGEIHDPSLNMU-MERQFXBCSA-N

Description

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

Application

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

Dexmedetomidine hydrochloride is a highly potent and selective α2-adrenergic agonist with analgesic and sedative properties, the (+)-isomer of medetomidine. Dexmedetomidine hydrochloride is used clinically as an anesthetic agent to reduce anxiety and tension and promote relaxation and sedation without causing respiratory depression.

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 LRAC5188 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.

Safety Information

• Pictograms: GHS07,GHS09
• Signal Word: Warning
• Hazard Statements: H302 - H336 - H411
• Precautionary Statements: P261 - P264 - P270 - P271 - P273 - P301 + P312
• Hazard Classifications: Acute Tox. 4 Oral - Aquatic Chronic 2 - STOT SE 3
• Target Organs: Respiratory system
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable