Menotropins Hormone Quantification Data from HPLC Method Validation

Yue Sun published a dataset on 2026-05-04 detailing a reversed-phase high-performance liquid chromatography (RP-HPLC) method for quantifying trace principal components in menotropins. The method was validated per ICH Q2(R1) and Chinese Pharmacopoeia guidelines and used to analyze 69 commercial batches of the drug. It provides precise quantification of α-subunits common to FSH, LH, and hCG, as well as FSH content, with detection limits of 3 ng (LOD) and 9 ng (LOQ).

Use Cases

• Validating HPLC methods for glycoprotein quantification based on the described RP-HPLC protocol.
• Comparing analytical and bioassay results for drug consistency based on the head-to-head comparison with animal assays mentioned.
• Assessing batch-to-batch variability in pharmaceutical production based on the analysis of 69 commercial batches.

Strengths

• Method validation followed ICH Q2(R1) and Chinese Pharmacopoeia guidelines, indicating a standardized approach.
• Analysis includes data from 69 commercial batches, providing a substantial real-world sample size.
• The method demonstrated high sensitivity with a limit of detection of 3 ng and limit of quantification of 9 ng.

Limitations

• Column-level documentation is absent; field semantics must be inferred after download.
• Row count is unknown, which may limit suitability assessment.
• The dataset is very small at 190.0 KB, indicating limited scope.

Provenance

Source

Author: Yue Sun. Platform: figshare.

Collection Method

Data generated via a developed RP-HPLC assay validated for specificity, precision, linearity, accuracy, robustness, and stability.

Freshness

Last updated 2026-05-04 05:32:00; freshness should be verified.