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PHR1782

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Hydroxychloroquine Sulfate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonyme(s) :

Hydroxychloroquine sulfate, 7-Chloro-4-[4-(N-ethyl-N-b-hydroxyethylamino)-1-methylbutylamino]quinoline sulfate

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About This Item

Formule empirique (notation de Hill):
C18H26ClN3O · H2SO4
Numéro CAS:
Poids moléculaire :
433.95
Numéro CE :
Numéro MDL:
Code UNSPSC :
41116107
ID de substance PubChem :
Nomenclature NACRES :
NA.24

Source biologique

synthetic

Niveau de qualité

Qualité

certified reference material
pharmaceutical secondary standard

Agence

BP
EP
USP
traceable to BP 1100
traceable to USP 1327000

Famille d'API

hydroxychloroquine

Forme

powder or crystals

CofA (certificat d'analyse)

current certificate can be downloaded

Conditionnement

pkg of 1 g

Conditions de stockage

protect from light

Technique(s)

HPLC: suitable
gas chromatography (GC): suitable

Couleur

white to off-white

pH

3.5-5.5 (1% in aqueous solution, pH <6.0)

Pf

238-241 °C

Solubilité

chloroform: practically insoluble
ethanol: practically insoluble
ether: practically insoluble
water: soluble

Application(s)

pharmaceutical (small molecule)

Conditions d'expédition

ambient

Température de stockage

2-30°C

Chaîne SMILES 

OS(O)(=O)=O.CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12

InChI

1S/C18H26ClN3O.H2O4S/c1-3-22(11-12-23)10-4-5-14(2)21-17-8-9-20-18-13-15(19)6-7-16(17)18;1-5(2,3)4/h6-9,13-14,23H,3-5,10-12H2,1-2H3,(H,20,21);(H2,1,2,3,4)

Clé InChI

JCBIVZZPXRZKTI-UHFFFAOYSA-N

Informations sur le gène

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Description générale

Hydroxychloroquine Sulfate (Hydroxychloroquine Sulphate) is a salt of hydroxychloroquine (HCQ, Plaquenil), a 4-aminoquinoline based antiviral drug.
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

Hydroxychloroquine Sulfate can be used as a pharmaceutical secondary standard for the determination of the analyte in pharmaceutical formulations, and biological samples by various analytical 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.

Actions biochimiques/physiologiques

Hydroxychloroquine sulfate is an anti-inflammatory (via TNF), disease-modifying antirheumatic drug (DMARD), and a heme polymerase inhibitor. It is used in treating malaria.

Remarque sur l'analyse

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Autres remarques

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.

Note de bas de page

To see an example of a Certificate of Analysis for this material enter LRAC0287 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Pictogrammes

Exclamation mark

Mention d'avertissement

Warning

Mentions de danger

Classification des risques

Acute Tox. 4 Oral - Eye Irrit. 2 - Skin Irrit. 2

Code de la classe de stockage

11 - Combustible Solids

Classe de danger pour l'eau (WGK)

WGK 3

Point d'éclair (°F)

Not applicable

Point d'éclair (°C)

Not applicable


Choose from one of the most recent versions:

Certificats d'analyse (COA)

Lot/Batch Number

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Retrouvez la documentation relative aux produits que vous avez récemment achetés dans la Bibliothèque de documents.

Consulter la Bibliothèque de documents

Seminars in Arthritis and Rheumatism, 43(2) (2013)
Hydroxychloroquine Sulfate
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 44(2)(12), 2259-2259 (2020)
Compatibility study of hydroxychloroquine sulfate with pharmaceutical excipients using thermal and nonthermal techniques for the development of hard capsules
Moraes ANF, et al.
Journal of Thermal Analysis and Calorimetry, 421 (2019)
Pharmacokinetics and bioequivalence study of hydroxychloroquine sulfate tablets in Chinese healthy volunteers by LC--MS/MS
Fan HW, et al.
Rheumatology and therapy, 2(2) (2015)
Development of a novel ion-pairing HPLC-FL method for the separation and quantification of hydroxychloroquine and its metabolites in whole blood
Charlier B,et al.
Biomedical Chromatography, 32(8), e4258-e4258 (2018)

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