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Y0000155

Tramadol hydrochloride

European Pharmacopoeia (EP) Reference Standard

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Synonym(s):
(±)-cis-2-(Dimethylaminomethyl)-1-(3-methoxyphenyl)cyclohexanol hydrochloride
Empirical Formula (Hill Notation):
C16H25NO2 · HCl
CAS Number:
36282-47-0
Molecular Weight:
299.84
MDL number:
MFCD00798507
UNSPSC Code:
41116107
PubChem Substance ID:
329830868
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
GHS06,GHS09

Signal Word

Danger

Hazard Statements

H301,H336,H411

Hazard Classifications

Acute Tox. 3 Oral - Aquatic Chronic 2 - STOT SE 3

Target Organs

Central nervous system

WGK

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

监管及禁止进口产品

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Kinetic spectrophotometric determination of tramadol hydrochloride in pharmaceutical formulation
Abdellatef EH
Journal of Pharmaceutical and Biomedical Analysis, 29(5), 835-842 (2002)
Analgesic oral efficacy of tramadol hydrochloride in postoperative pain
Sunshine A, et al.
Clinical Pharmacology and Therapeutics, 51(6), 740-746 (1992)
Application of HPLC for the simultaneous determination of aceclofenac, paracetamol and tramadol hydrochloride in pharmaceutical dosage form
Chandra P, et al.
Scientia Pharmaceutica, 80(2), 337-352 (2012)
HPLC determination and validation of tramadol hydrochloride in capsules
Kartinasari FW, et al.
Journal of Liquid Chromatography and Related Technologies, 27(4), 737-744 (2004)
The clinical use of tramadol hydrochloride
Bamigbade AT and Langford MR
Pain, 5(6), 155-182 (1998)
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