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Y0000155

Tramadol hydrochloride

European Pharmacopoeia (EP) Reference Standard

Synonym(s):

(±)-cis-2-(Dimethylaminomethyl)-1-(3-methoxyphenyl)cyclohexanol hydrochloride

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About This Item

Empirical Formula (Hill Notation):
C16H25NO2 · HCl
CAS Number:
Molecular Weight:
299.84
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

grade

pharmaceutical primary standard

API family

tramadol

manufacturer/tradename

EDQM

drug control

USDEA Schedule IV

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

SMILES string

Cl.COc1cccc(c1)[C@@]2(O)CCCC[C@@H]2CN(C)C

InChI

1S/C16H25NO2.ClH/c1-17(2)12-14-7-4-5-10-16(14,18)13-8-6-9-15(11-13)19-3;/h6,8-9,11,14,18H,4-5,7,10,12H2,1-3H3;1H/t14-,16+;/m1./s1

InChI key

PPKXEPBICJTCRU-XMZRARIVSA-N

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General description

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the Issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia.

Tramadol is a synthetic opiate agonist analgesic, widely used in patients suffering from moderate to severe chronic pain. It is considered safe when compared to other opioids. It contributes to the analgesic activity by blocking the nociceptive impulses at the spinal level, inhibiting the norepinephrine and serotonin reuptake.

Application

This European Pharmacopoeia reference standard is intended for use only as specifically prescribed in the European Pharmacopoeia.

Biochem/physiol Actions

Opioid analgesic; P450 substrate.

Packaging

The product is delivered as supplied by the issuing Pharmacopoeia. For the current unit quantity, please visit the EDQM reference substance catalogue.

Other Notes

Sales restrictions may apply.

Pictograms

Skull and crossbonesEnvironment

Signal Word

Danger

Hazard Statements

Hazard Classifications

Acute Tox. 3 Oral - Aquatic Chronic 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 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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Analgesic oral efficacy of tramadol hydrochloride in postoperative pain
Sunshine A, et al.
Clinical Pharmacology and Therapeutics, 51(6), 740-746 (1992)
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The use of process analytical technologies (PAT) to ensure final product quality is by now a well established practice in pharmaceutical industry. To date, most of the efforts in this field have focused on development of analytical methods using spectroscopic

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