HCG – HPLC immunoassay alternative

The HCG – HPLC Immunoassay Alternative is a targeted laboratory test designed to confirm the identity and determine the amount of human chorionic gonadotropin (HCG) in lyophilised vials and raw active pharmaceutical ingredient (API) powders.

For lyophilised samples, results are reported in international units (IU) per vial. Raw API powders can be evaluated using an alternative result format based on purity in % (m/m). Peptide purity is not determined for HCG as part of this analysis.

About HCG

Human chorionic gonadotropin (HCG) is a glycoprotein hormone composed of two subunits, alpha and beta. It is naturally produced primarily during pregnancy and acts through the luteinizing hormone/chorionic gonadotropin receptor (LH/CG receptor).

For high-purity HCG samples, HPLC enables accurate determination of HCG content, which generally corresponds well to the biological activity of the sample. In lower-purity samples, however, different HCG bioforms and partially active derivatives may be detected as impurities by conventional HPLC even though they contribute to biological activity. As a result, conventional HPLC may not fully reflect the biological activity of the sample.

To address this limitation, the laboratory developed its own HPLC method as an alternative to immunoassay-based HCG determination. The method is designed so that HPLC results for HCG correspond as closely as possible to immunoassay results.

Key Features

• Targeted identification and quantification of HCG
• Suitable for lyophilised vials and raw API powders
• HPLC-based immunoassay alternative
• Results for lyophilised samples reported in IU per vial
• Alternative purity reporting in % (m/m) for raw API powders
• Peptide purity is not determined
• Minimum sample amount of one whole unopened vial with lyophilisate
• Minimum sample amount of 30 mg for raw API powders
• Average turnaround time of 7 business days

Analysis Parameters

• Target compound: Human chorionic gonadotropin
• Other name: HCG
• Molecular weight: 36700 Da
• Testing method: HPLC immunoassay alternative
• Result format for lyophilised samples: IU per vial
• Result format for raw API powders: Purity in % (m/m)
• Minimum sample amount for lyophilised samples: One whole unopened vial with lyophilisate
• Minimum sample amount for raw API powders: 30 mg in a sealed glass vial to prevent the sample from absorbing moisture
• Average turnaround time: 7 business days

Important Notice

• Peptide purity is not tested for HCG as part of this analysis.
• In high-purity HCG samples, HPLC determination can correlate well with biological activity. In lower-purity samples, different HCG bioforms and partially active hormone derivatives may appear as impurities by conventional HPLC despite contributing to biological activity.
• The HPLC immunoassay alternative is designed to provide a more consistent relationship between HPLC-based HCG determination and immunoassay results.
• For lyophilised samples, one whole unopened vial containing lyophilisate is required.
• Raw API powder should be supplied as at least 30 mg in a sealed glass vial to minimise moisture absorption.
• This analysis does not automatically screen the sample for other hormones, proteins, contaminants, or undeclared substances.

Optional Additional Analyses

The following optional laboratory services are available:

• TFA Analysis
• Complete Raw Analytical Data
• Fentanyl Screening
• Alternative Result Format: Purity in % (m/m)
• Batch Variance Testing
• pH Measurement
• Endotoxin Analysis
• CHNS Mass Report
• Sterility Testing (TAMC + TYMC)
• Heavy Metals Analysis (As, Cd, Pb, Hg)
• Additional Laboratory Report