HCG – HPLC analysis

The HCG – HPLC Analysis 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).

HCG is widely used in clinical and research settings because of its hormone activity and its ability to stimulate the LH/CG receptor. This HPLC analysis is designed to determine the amount of HCG in submitted samples without assessing peptide purity.

Key Features

• Targeted identification and quantification of HCG
• Suitable for lyophilised vials and raw API powders
• Analysis by HPLC
• 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
• 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 determined for HCG as part of this analysis.
• This analysis is specifically intended for HCG. It does not automatically screen the sample for other hormones, proteins, contaminants, or undeclared substances.
• 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.
• Purity reporting in % (m/m) is available for raw API powders as an alternative result format.

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