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PHR1782

Supelco

Hydroxychloroquine Sulfate

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Hydroxychloroquine sulfate, 7-Chloro-4-[4-(N-ethyl-N-b-hydroxyethylamino)-1-methylbutylamino]quinoline sulfate
Empirical Formula (Hill Notation):
C18H26ClN3O · H2SO4
CAS Number:
Molecular Weight:
433.95
EC Number:
MDL number:
PubChem Substance ID:
NACRES:
NA.24

biological source

synthetic

Quality Level

grade

certified reference material
pharmaceutical secondary standard

agency

BP
EP
USP
traceable to BP 1100
traceable to USP 1327000

API family

hydroxychloroquine

form

powder or crystals

CofA

current certificate can be downloaded

packaging

pkg of 1 g

storage condition

protect from light

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

color

white to off-white

pH

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

mp

238-241 °C

solubility

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

application(s)

pharmaceutical (small molecule)

shipped in

ambient

storage temp.

2-30°C

SMILES string

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)

InChI key

JCBIVZZPXRZKTI-UHFFFAOYSA-N

Gene Information

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This Item
90527H09151327000
vibrant-m

PHR1782

Hydroxychloroquine Sulfate

vibrant-m

90527

Hydroxychloroquine sulfate

vibrant-m

H0915

Hydroxychloroquine sulfate

vibrant-m

1327000

Hydroxychloroquine sulfate

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

-

technique(s)

-

application(s)

pharmaceutical (small molecule)

application(s)

forensics and toxicology
pharmaceutical (small molecule)
veterinary

application(s)

-

application(s)

pharmaceutical (small molecule)

form

powder or crystals

form

-

form

powder

form

-

storage temp.

2-30°C

storage temp.

2-8°C

storage temp.

-

storage temp.

-

grade

certified reference material, pharmaceutical secondary standard

grade

analytical standard

grade

-

grade

pharmaceutical primary standard

General description

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.

Biochem/physiol Actions

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

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP 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.

Footnote

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.

pictograms

Exclamation mark

signalword

Warning

Hazard Classifications

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

Storage Class

11 - Combustible Solids

wgk_germany

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable


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Chloroquine phosphate United States Pharmacopeia (USP) Reference Standard

USP

1118000

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Lys05 &#8805;98% (HPLC)

Sigma-Aldrich

SML2097

Lys05

Chloroquine Related Compound D United States Pharmacopeia (USP) Reference Standard

USP

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Chloroquine Related Compound A United States Pharmacopeia (USP) Reference Standard

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Y0001839

Hydroxychloroquine sulfate

vibrant-m

BP1210

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Sigma-Aldrich

Sigma-Aldrich

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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)
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)
A rapid and reliable method for the quantitation of hydroxychloroquine in serum using turbulent flow liquid chromatography-tandem mass spectrometry
Fuzery AK, et al.
Clinica Chimica Acta; International Journal of Clinical Chemistry, 421 (2013)
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)

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