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PHR1026

Ranitidine hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Sinónimos:

N, N Dimethyl-5-[2-(1-methylamine-2-nitrovinyl)-ethylthiomethyl]furfurylamine hydrochloride

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Fórmula empírica (notación de Hill):
C13H22N4O3S · HCl
Número CAS:
66357-59-3
Peso molecular:
350.86
NACRES:
NA.24
PubChem Substance ID:
329823056
UNSPSC Code:
41116107
EC Number:
266-333-0
MDL number:
MFCD00069339
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Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. R0150000, traceable to USP 1598405

API family

ranitidine

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[H].CN\C(NCCSCc1ccc(CN(C)C)o1)=C\[N+]([O-])=O

InChI

1S/C13H22N4O3S.ClH/c1-14-13(9-17(18)19)15-6-7-21-10-12-5-4-11(20-12)8-16(2)3;/h4-5,9,14-15H,6-8,10H2,1-3H3;1H/b13-9-;

InChI key

GGWBHVILAJZWKJ-CHHCPSLASA-N

General description

Ranitidine hydrochloride is a H2-receptor antagonist, widely used for the management of hypersecretory conditions and for the treatment of duodenal ulcer.
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

Ranitidine hydrochloride may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using titrimetry and visible spectrophotometry techniques.
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

H2 histamine receptor antagonist; anti-ulcer agent.
H2 histamine receptor antagonist; anti-ulcer agent.

Analysis Note

These secondary standards offer multi-traceability to the USP and EP (PhEur) 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.
To see an example of a Certificate of Analysis for this material enter LRAA5630 in the slot below. This is an example certificate only and may not be the lot that you receive.

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pictograms

Health hazardExclamation mark
GHS08,GHS07

signalword

Danger

Hazard Classifications

Eye Irrit. 2 - Resp. Sens. 1 - Skin Irrit. 2 - Skin Sens. 1 - STOT SE 3

target_organs

Respiratory system

Clase de almacenamiento

11 - Combustible Solids

flash_point_f

Not applicable

flash_point_c

Not applicable

Certificados de análisis (COA)

Busque Certificados de análisis (COA) introduciendo el número de lote del producto. Los números de lote se encuentran en la etiqueta del producto después de las palabras «Lot» o «Batch»

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Spectrophotometric determination of ranitidine hydrochloride based on the reaction with p-dimethylaminobenzaldehyde
Narayana B, et al.
Eurasian Journal of Analytical Chemistry, 5(1), 63-72 (2010)
Julien Le Roux et al.
Environmental science & technology, 46(20), 11095-11103 (2012-09-13)
The kinetics of decomposition of the pharmaceutical ranitidine (a major precursor of NDMA) during chloramination was investigated and some decomposition byproducts were identified by using high performance liquid chromatography coupled with mass spectrometry (HPLC-MS). The reaction between monochloramine and ranitidine
Gaia Rocchitta et al.
Analytical chemistry, 84(16), 7072-7079 (2012-07-25)
Ethanol is one of the most widespread psychotropic agents in western society. While its psychoactive effects are mainly associated with GABAergic and glutamatergic systems, the positive reinforcing properties of ethanol are related to activation of mesolimbic dopaminergic pathways resulting in
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