Estradiol Blind Screening

The Estradiol Blind Screening is a targeted laboratory test designed to identify and quantify estradiol and selected estradiol esters in oil-based samples and raw active pharmaceutical ingredient (API) powders.

With blind testing, the specific estradiol ester does not need to be declared in advance. All target compounds included in the analysis are screened, identified, and quantified, including mixtures containing more than one estradiol form.

About Estradiol and Estradiol Esters

Estradiol is a naturally occurring estrogen hormone. Esterification of estradiol produces derivatives with different physicochemical and pharmacokinetic properties.

This screening covers estradiol without an ester as well as several commonly encountered estradiol esters, including benzoate, cypionate, enanthate, undecylenate, and valerate. Estradiol hemihydrate is also included in the screening.

Key Features

• Blind identification and quantification of estradiol and selected estradiol esters
• No need to specify the expected ester before testing
• Detection of multiple estradiol forms within mixtures
• Suitable for oil-based samples and raw API powders
• Analysis by HPLC
• Results for oil samples reported in mg/ml
• Alternative results for raw API powders reported as percentage content
• Minimum sample amount of 0.5–1 ml for oil samples
• Minimum sample amount of 200 mg for raw API powders
• Average turnaround time of 7 business days

Analysis Parameters

• Target compounds: Estradiol hemihydrate, Estradiol benzoate, Estradiol cypionate, Estradiol enanthate, Estradiol no ester, Estradiol undecylenate, Estradiol valerate
• Testing method: HPLC
• Result format for oil samples: mg/ml
• Alternative result format for raw API powders: % [98%+, 96%+ or % value such as 94.15%]
• Minimum sample amount for oil samples: 0.5–1 ml of oil
• Minimum sample amount for raw API powders: 200 mg
• Average turnaround time: 7 business days

Important Notice

• Due to limitations of the analytical method, estradiol hemihydrate will be identified as estradiol no ester (estradiol base).
• The analysis covers only the estradiol forms listed in the analysis parameters. It does not automatically screen the sample for other estrogens, related compounds, contaminants, or undeclared substances.

Optional Additional Analyses

The following optional laboratory services are available:

• Complete Raw Analytical Data
• Fentanyl Screening
• Alternative Result Format: Purity in % (m/m)
• pH Measurement
• GC–MS Contamination Screening
• Sterility Testing (TAMC + TYMC)
• Heavy Metals Analysis (As, Cd, Pb, Hg)
• Additional Laboratory Report