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1327000

USP

Hydroxychloroquine sulfate

United States Pharmacopeia (USP) Reference Standard

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:
Molecular Weight:
433.95
EC Number:
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

biological source

synthetic

grade

pharmaceutical primary standard

Agency

USP

API family

hydroxychloroquine

packaging

pkg of 200 mg

manufacturer/tradename

USP

storage condition

protect from light

color

white to off-white

pH

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

mp

388.4 °F (198°C; 240°C)

solubility

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

application(s)

pharmaceutical (small molecule)

format

neat

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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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.

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

Application

Hydroxychloroquine sulfate USP reference standard, intended for use in specified quality tests and assays as specified in the USP compendia. Also, for use with USP monographs such as:
  • Hydroxychloroquine Sulfate Tablets
  • Hydroxychloroquine Sulfate Compounded Oral Suspension
  • Chloroquine Phosphate

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 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

Exclamation mark

Signal Word

Warning

Hazard Statements

Hazard Classifications

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

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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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Hydroxychloroquine Sulfate
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 44(2) (2021)
Seminars in Arthritis and Rheumatism, 43(2), 264-272 (2013)
Chloroquine Phosphate
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 39(3), 959-959 (2020)
Sandhya C Nair et al.
Arthritis care & research, 66(7), 998-1007 (2014-01-01)
Pragmatic clinical trials have been proposed as a solution for nongeneralizability of randomized clinical trial (RCT) results. We investigated whether treatment effects of pragmatic clinical trials are indeed generalizable to clinical practice and how efficacy estimates from published RCTs can
H N Bernstein
Southern medical journal, 85(3), 274-279 (1992-03-01)
Analysis of all published cases and Food and Drug Administration (FDA) reports of retinopathy attributed to hydroxychloroquine sulfate (Plaquenil) does not reveal any evidence of permanent visual field scotoma occurring when the daily dose is related to body weight and

Protocols

Chloroquine Phosphate HPLC Assay meets system suitability criteria with good resolution, reproducibility, and sensitivity.

Chloroquine Phosphate HPLC Assay meets system suitability criteria with good resolution, reproducibility, and sensitivity.

Chloroquine Phosphate HPLC Assay meets system suitability criteria with good resolution, reproducibility, and sensitivity.

Chloroquine Phosphate HPLC Assay meets system suitability criteria with good resolution, reproducibility, and sensitivity.

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