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Tramadol hydrochloride

United States Pharmacopeia (USP) 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:
329751360
NACRES:
NA.24

grade

pharmaceutical primary standard

API family

tramadol

manufacturer/tradename

USP

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.

Application

Tramadol hydrochloride USP reference standard for use in specified quality tests and assays.

Also used to prepare standard, system suitability, standard stock, and system suitability stock solutions for assay, impurity analysis, and performance tests according to the given below monographs of United States Pharmacopeia (USP):
  • Tramadol Hydrochloride and Acetaminophen Tablets
  • Tramadol Hydrochloride Extended-Release Tablets
  • Tramadol Hydrochloride
  • Tramadol Hydrochloride Tablets

Biochem/physiol Actions

Opioid analgesic; P450 substrate.

Analysis Note

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  ​

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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Tramadol Hydrochloride Extended-Release Tablets
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 36(6), 4446-4446 (2020)
Tramadol Hydrochloride Tablets
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 36(6), 4444-4444 (2020)
Tramadol Hydrochloride
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 38(5), 4441-4441 (2020)
Tramadol Hydrochloride and Acetaminophen Tablets
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 42(1), 4450-4450 (2017)

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