PHR1782

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
• 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

Properties

• 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)

Description

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.

Safety Information

• Pictograms: GHS07
• Signal Word: Warning
• Hazard Statements: H302,H315,H319
• Precautionary Statements: P301 + P312 + P330 - P305 + P351 + P338
• 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