PHR2880

Levothyroxine Sodium Hydrate

pharmaceutical secondary standard, certified reference material

• Synonym(s): Levothyroxine sodium hydrate, 3,3′,5,5′-Tetraiodo-L-thyronine monosodium salt hydrate, L-Thyroxin monosodium salt hydrate, Sodium O-(4-hydroxy-3,5-diiodophenyl)-3,5-diiodo-L-tyrosine hydrate
• Empirical Formula (Hill Notation): C₁₅H₁₀I₄NNaO₄ · xH₂O
• CAS Number: 25416-65-3
• Molecular Weight: 798.85 (anhydrous basis)
• MDL number: MFCD06408007
• UNSPSC Code: 41116107

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to USP 1365065
• API family: levothyroxine
• CofA: current certificate can be downloaded
• packaging: pkg of 100 mg
• application(s): pharmaceutical
• storage temp.: 2-30°C
• SMILES string: O.[Na+].N[C@@H](Cc1cc(I)c(Oc2cc(I)c(O)c(I)c2)c(I)c1)C([O-])=O
• InChI: 1S/C15H11I4NO4.Na.H2O/c16-8-4-7(5-9(17)13(8)21)24-14-10(18)1-6(2-11(14)19)3-12(20)15(22)23;;/h1-2,4-5,12,21H,3,20H2,(H,22,23);;1H2/q;+1;/p-1/t12-;;/m0../s1
• InChI key: ANMYAHDLKVNJJO-LTCKWSDVSA-M

Description

General description

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

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.

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.

Recommended products

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Safety Information

• Pictograms: GHS08
• Signal Word: Danger
• Hazard Statements: H372
• Precautionary Statements: P260 - P264 - P270 - P314 - P501
• Hazard Classifications: STOT RE 1
• Storage Class Code: 6.1C - Combustible, acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable