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Key Documents

PHR1129

Supelco

Tetracaine hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

4-(Butylamino)benzoic acid 2-(dimethylamino)ethyl ester, Amethocaine hydrochloride

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About This Item

Empirical Formula (Hill Notation):
C15H24N2O2 · HCl
CAS Number:
Molecular Weight:
300.82
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. T0500000
traceable to USP 1650006

API family

tetracaine

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

Cl.CCCCNc1ccc(cc1)C(=O)OCCN(C)C

InChI

1S/C15H24N2O2.ClH/c1-4-5-10-16-14-8-6-13(7-9-14)15(18)19-12-11-17(2)3;/h6-9,16H,4-5,10-12H2,1-3H3;1H

InChI key

PPWHTZKZQNXVAE-UHFFFAOYSA-N

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General description

Tetracaine hydrochloride is a local anesthetic drug and an ester derivative of p-amino benzoic acid. It acts by interfering with the entry of sodium ions into nerve cells and is one of the commonly used topical anesthetics.
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

Tetracaine hydrochloride may be used as a pharmaceutical reference standard for the determination of the analyte in bulk drug and pharmaceutical formulations by 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.
Topical ophthalmic anesthetic; used for spinal anesthesia

Biochem/physiol Actions

Blocks voltage-sensitive release of Ca2+ from sarcoplasmic reticulum.

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 LRAA7150 in the slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Skull and crossbones

Signal Word

Danger

Hazard Statements

Hazard Classifications

Acute Tox. 3 Oral - Eye Irrit. 2 - STOT SE 3

Target Organs

Central nervous system

Storage Class Code

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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Local Anesthetic Pharmacology
Principles of Pharmacology: The Pathophysiologic Basis of Drug Therapy, 206-220 (2017)
Determination of Two Components in Tetracaine Hydrochloride Eye Drops by HPLC [J]
Yahong L, et al.
Chinese Pharmaceutical Journal, 14(2), 381-386 (2009)
14 - Local Anesthetics
Pharmacology and Therapeutics for Dentistry, 206-220 (2017)
Tetracaine hydrochloride
European Pharmacopoeia Commission and European Directorate for the Quality of Medicines & Healthcare
European pharmacopoeia, 3742-3743 (2017)
Tetracaine hydrochloride
Pharmacopeia, US
United States Pharmacopeia/National Formulary, 4106-4106 (2018)

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