PHR1607

Hydroxyzine Dihydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Hydroxyzine dihydrochloride
• Empirical Formula (Hill Notation): C₂₁H₂₇ClN₂O₂ · 2HCl
• CAS Number: 2192-20-3
• Molecular Weight: 447.83
• EC Number: 218-586-3
• MDL number: MFCD00058200
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823504

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to BP 841; traceable to Ph. Eur. H1435000; traceable to USP 1333003
• API family: hydroxyzine
• 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.: 2-8°C
• SMILES string: Cl[H].Cl[H].OCCOCCN1CCN(CC1)C(c2ccccc2)c3ccc(Cl)cc3
• InChI: 1S/C21H27ClN2O2.2ClH/c22-20-8-6-19(7-9-20)21(18-4-2-1-3-5-18)24-12-10-23(11-13-24)14-16-26-17-15-25;;/h1-9,21,25H,10-17H2;2*1H
• InChI key: ANOMHKZSQFYSBR-UHFFFAOYSA-N
• Gene Information: human ... HRH1(3269)

Description

General description

Hydroxyzine dihydrochloride is an antihistaminic drug and a member of the diphenylmethanes family. It exerts its action by blocking the action of histamine, a substance in the body that causes allergic symptoms.
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

Hydroxyzine dihydrochloride may be used as a pharmaceutical reference standard for the determination of the analyte in bulk drug and pharmaceutical formulations by spectrophotometry and high performance liquid chromatography.

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 LRAA4723 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Pictograms: GHS07,GHS08
• Signal Word: Warning
• Hazard Statements: H302 - H336 - H361d
• Precautionary Statements: P202 - P261 - P264 - P271 - P301 + P312 - P308 + P313
• Hazard Classifications: Acute Tox. 4 Oral - Repr. 2 - STOT SE 3
• Target Organs: Central nervous system
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable