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PHR1782

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Hydroxychloroquine Sulfate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

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

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About This Item

Empirical Formula (Hill Notation):
C18H26ClN3O · H2SO4
CAS Number:
747-36-4
Molecular Weight:
433.95
EC Number:
212-019-3
MDL number:
MFCD00078203
UNSPSC Code:
41116107
PubChem Substance ID:
329823611
NACRES:
NA.24

biological source

synthetic

Quality Level

300

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

human ... TLR7(51284) , TLR9(54106)

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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
GHS07

Signal Word

Warning

Hazard Statements

H302,H315,H319

Hazard Classifications

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

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Choose from one of the most recent versions:

Certificates of Analysis (COA)

Lot/Batch Number
LRAE0036
LRAC7776
LRAC0287
LRAA8559

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If you require a particular version, you can look up a specific certificate by the Lot or Batch number.

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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)
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)
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)
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