T4 analysis

The T4 Analysis is a targeted laboratory test designed to confirm the identity and determine the amount of T4 (thyroxine) in oral dosage forms and raw active pharmaceutical ingredient (API) powders.

The analysis is suitable for pills, tablets, and capsules, with results reported in micrograms per tablet or capsule. Raw API powders can be evaluated by percentage content, with optional purity reporting in % (m/m).

About T4

T4, or thyroxine, is the major thyroid hormone produced and secreted by the thyroid gland. It plays an important role in the regulation of metabolism, growth, development, and energy utilisation. Much of circulating T4 is converted in peripheral tissues to the more biologically active thyroid hormone T3.

Levothyroxine is the synthetic form of T4 and is widely used as thyroid hormone replacement therapy, particularly in the treatment of hypothyroidism.

Key Features

• Targeted identification and quantification of T4
• Suitable for pills, tablets, capsules, and raw API powders
• Analysis by HPLC
• Results for oral products reported in mcg per tablet or capsule
• Results for raw API powders reported as percentage content
• Optional purity reporting in % (m/m) for raw API powders
• Minimum sample amount of three tablets or capsules
• Minimum sample amount of 200 mg for raw API powders
• Average turnaround time of 7 business days

Analysis Parameters

• Target compound: T4
• Other name: Thyroxine
• Testing method: HPLC
• Minimum amount of target compound for evaluation in oral products: 15 mcg per pill, tablet, or capsule
• Minimum content of target compound for evaluation in raw API powders: 5%
• Result format for oral products: mcg per tablet or capsule
• Result format for raw API powders: % [98%+, 96%+ or % value such as 94.15%]
• Minimum sample amount for oral products: Three tablets or capsules
• Minimum sample amount for raw API powders: 200 mg
• Average turnaround time: 7 business days

Important Notice

• This analysis is specifically intended for T4. It does not automatically screen the sample for other thyroid hormones, related compounds, contaminants, or undeclared substances.
• For oral products, the minimum amount of T4 required for evaluation is 15 mcg per pill, tablet, or capsule. For raw API powders, the minimum content is 5%. Samples below these values may not be reliably evaluated within the standard scope of the analysis.
• Purity reporting in % (m/m) is available only for raw API powders.

Optional Additional Analyses

The following optional laboratory services are available:

• Complete Raw Analytical Data
• Alternative Result Format: Purity in % (m/m) – only for raw API powders
• Batch Variance Testing
• Fentanyl Screening
• GCMS Contamination Screening
• Heavy Metals Analysis (As, Cd, Pb, Hg)
• Additional Laboratory Report