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Safety Information

PHR1613

Supelco

Levothyroxine

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

L-Thyroxine, 3,3′,5,5″-Tetraiodo-L-thyronine, 3-[4-(4-Hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]-L-alanine, T4

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1 G
CN¥1,344.81
10 X 10 MG
CN¥3,757.79
5 G
CN¥5,150.21

CN¥1,344.81

Available to ship onApril 24, 2025Details

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1 G
CN¥1,344.81
10 X 10 MG
CN¥3,757.79
5 G
CN¥5,150.21

About This Item

Linear Formula:
HOC6H2(I)2OC6H2(I)2CH2CH(NH2)CO2H
CAS Number:
51-48-9
Molecular Weight:
776.87
Beilstein:
2228515
EC Number:
200-101-1
MDL number:
MFCD00002595
UNSPSC Code:
41116107
PubChem Substance ID:
329823509
NACRES:
NA.24

CN¥1,344.81

Available to ship onApril 24, 2025Details

Request a Bulk Order

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to Ph. Eur. L0570000
traceable to USP 1365000

API family

levothyroxine

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

mp

223 °C (dec.) (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

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Super-DHB suitable for matrix substance for MALDI-MS, ≥99.0%

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SIGMAFAST™ DAB，含金属增强剂

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6-乙氧基-2-巯基苯并噻唑 99%

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6-乙氧基-2-巯基苯并噻唑

analyte functional class(es)

polymers

analyte functional class(es)

-

analyte functional class(es)

-

analyte functional class(es)

-

analyte chemical class(es)

glycans, peptides, proteins

analyte chemical class(es)

-

analyte chemical class(es)

-

analyte chemical class(es)

-

technique(s)

MALDI-MS: suitable

technique(s)

-

technique(s)

-

technique(s)

-

solubility

methanol: 1%, clear

solubility

water: 1 tablet/5 mL

solubility

-

solubility

-

cation traces

Ca: ≤5 mg/kg

cation traces

-

cation traces

-

cation traces

-

General description

Levothyroxine is a thyroid hormone that is responsible for the physiological actions such as growth, cardiac functionality, and regulation of carbohydrates, lipid, and protein metabolisms.[1]
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

Levothyroxine may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations and bulk dosage forms[2][3] and oral liquid formulations[1] by chromatography.
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

L-Thyroxine (T4) and triiodo-L-thyronine (T3) are iodine-containing hormones produced from thyroglobulin in the thyroid follicular cells. The stimulation of metabolic rate and regulation of growth and development by these hormones appear to be due to their effects on DNA transcription and, thus, protein synthesis.

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 LRAC1514 in the slot below. This is an example certificate only and may not be the lot that you receive.

Recommended products

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

Pictograms

Health hazard
GHS08

Signal Word

Danger

Hazard Statements

H372

Precautionary Statements

P260 - P264 - P270 - P314 - P501

Hazard Classifications

STOT RE 1

Target Organs

Thyroid,Cardio-vascular system,Kidney

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

Regulatory Information

监管及禁止进口产品
  • Specification Sheet

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    Oral liquid formulation of levothyroxine is stable in breakfast beverages and may improve thyroid patient compliance
    Bernareggi A, et al.
    Pharmaceutics, 5(4), 621-633 (2013)
    The separation and determination of liothyronine and levothyroxine in tablets by reversed-phase high performance liquid chromatography
    Smith DJ, et al.
    Journal of Chromatographic Science, 19(2), 72-78 (1981)
    Determination of liothyronine and levothyroxine in thyroid preparations by liquid chromatography
    Richheimer SL and Jensen CB
    Journal of Pharmaceutical Sciences, 75(2), 215-217 (1986)

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