Human Growth Hormone amount and purity analysis

The Human Growth Hormone Amount and Purity Analysis is a targeted laboratory test designed to confirm the identity, determine the amount, and assess the purity of human growth hormone (HGH) in lyophilised vials, liquid samples, and raw active pharmaceutical ingredient (API) powders.

For lyophilised samples, results are reported in mg per vial, international units (IU), and percentage purity. Liquid samples are reported in mg/ml, IU, and percentage purity. Raw API powders can be evaluated using an alternative result format based on purity in % (m/m) together with GH purity.

About Human Growth Hormone

Human growth hormone (HGH), also known as somatropin or GH, is a polypeptide hormone composed of 191 amino acids. Recombinant somatropin has the same amino acid sequence as the predominant form of human growth hormone produced by the pituitary gland.

Growth hormone acts through specific GH receptors and regulates a range of growth and metabolic processes, both directly and through factors such as insulin-like growth factor 1 (IGF-1).

Key Features

• Targeted identification and quantification of human growth hormone (HGH)
• Determination of HGH purity
• Specifically recognizes HGH with 191 amino acids
• Suitable for lyophilised vials, liquid samples, and raw API powders
• Analysis by HPLC
• Results for lyophilised samples reported in mg/vial, IU, and % purity
• Results for liquid samples reported in mg/ml, IU, and % purity
• Alternative result format for raw API powders includes purity in % (m/m) and GH purity
• Minimum sample amount of one whole unopened vial with lyophilisate
• Minimum liquid sample amount of 1 ml
• Minimum sample amount of 30 mg for raw API powders
• Average turnaround time of 7 business days

Analysis Parameters

• Target compound: Human Growth Hormone 191 AA
• Other names: Somatropin, HGH, rhGH, 191 AA
• Molecular weight: 22124 Da
• Testing method: HPLC
• Minimum amount of target compound for evaluation: 0.2 mg HGH/ml or 0.5 mg HGH/vial
• Result format for lyophilised samples: mg/vial, IU, % purity
• Result format for liquid samples: mg/ml, IU, % purity
• Result format for raw API powders: Purity in % (m/m) and GH purity
• Minimum sample amount for lyophilised samples: One whole unopened vial with lyophilisate
• Minimum sample amount for liquid samples: 1 ml
• 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

• This analysis does not include testing for HGH dimers or higher molecular weight proteins. A dedicated HGH amount, purity, dimer, and higher molecular weight proteins analysis is required for these parameters.
• The test specifically recognizes HGH 191 AA. HGH 192 AA is not considered human growth hormone within the scope of this analysis and will be reported as “HGH not detected.”
• 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 proteins, peptides, 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
• LCMS Screening For Peptide Contamination
• Sterility Testing (TAMC + TYMC)
• Heavy Metals Analysis (As, Cd, Pb, Hg)
• Additional Laboratory Report