PHR3069

Olopatadine Hydrochloride

pharmaceutical secondary standard, certified reference material

• Synonym(s): Olopatadine hydrochloride, (11Z)-11-[3-(Dimethylamino)propylidene]-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid hydrochloride, AL-4943A, KW-4679, Opatanol, Patanol
• Empirical Formula (Hill Notation): C₂₁H₂₃NO₃·HCl
• CAS Number: 140462-76-6
• Molecular Weight: 373.87
• MDL number: MFCD00875716
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• agency: traceable to USP 1478403
• CofA: current certificate can be downloaded
• packaging: pkg of 300 mg
• application(s): pharmaceutical
• SMILES string: Cl.CN(C)CC\C=C1\c2ccccc2COc3ccc(CC(O)=O)cc13
• InChI: 1S/C21H23NO3.ClH/c1-22(2)11-5-8-18-17-7-4-3-6-16(17)14-25-20-10-9-15(12-19(18)20)13-21(23)24;/h3-4,6-10,12H,5,11,13-14H2,1-2H3,(H,23,24);1H/b18-8-;
• InChI key: HVRLZEKDTUEKQH-NOILCQHBSA-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

Olopatadine is a histamine H1 receptor antagonist and mast cell stabilizer. The low level of occupancy H1 receptors in the brain explains the low sedation effect of olopatidine. It is believed that olopatidine is a substrate for P-glycoprotein, which limits its brain penetration.

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 LRAA6959(changes by product) in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• pictograms: GHS06,GHS09
• signalword: Danger
• hcodes: H301,H400
• pcodes: P264 - P270 - P273 - P301 + P310 - P391 - P405
• Hazard Classifications: Acute Tox. 3 Oral - Aquatic Acute 1
• Storage Class: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• wgk_germany: WGK 3
• flash_point_f: Not applicable
• flash_point_c: Not applicable