Certified Oncology API: Lab Verifies Blue Eyes Biotech Paclitaxel Extract Meets USP Monograph for High-Purity Drug Manufacturing

Article Title: Certified Oncology API: Lab Verifies Blue Eyes Biotech Paclitaxel Extract Meets USP Monograph for High-Purity Drug Manufacturing

Detail Page Description: An independent, cGMP-compliant laboratory releases a critical quality dossier on Paclitaxel Extract supplied by Blue

Eyes Biotech. This report confirms ≥99.0% chromatographic purity, precise HPLC fingerprinting, and full compliance with USP and EP

standards, establishing it as a reliable Active Pharmaceutical Ingredient (API) for injectable oncology formulations.

Body:

This document presents the definitive analytical findings from an independent, internationally accredited testing laboratory regarding the

core pharmaceutical quality attributes of Paclitaxel Extract produced by Blue Eyes Biotech CO., Ltd. As a critical chemotherapeutic agent,

the purity, identity, and consistency of paclitaxel are non-negotiable for patient safety and drug efficacy. This rigorous analysis provides

global pharmaceutical manufacturers and oncology drug developers with objective, data-driven assurance of a fully compliant and potent

raw material.

The assessment’s foundation is the precise quantification of chromatographic purity and related substances. Using a validated

High-Performance Liquid Chromatography (HPLC) method strictly aligned with the United States Pharmacopeia (USP) monograph,

the Paclitaxel Extract from Blue Eyes Biotech demonstrated a main peak purity exceeding 99.0%. A comprehensive related substances

analysis quantified all known and unknown impurities, with total levels well below the stringent identification and qualification thresholds

defined in the ICH Q3A guideline. This exceptional purity profile is a direct result of Blue Eyes Biotech's advanced purification and

crystallization technology, minimizing the risk of unpredictable side effects in final drug products.

Furthermore, the laboratory conducted a multi-technique identity and structure confirmation. The specific optical rotation and melting point

range of the sample matched USP specifications perfectly. Fourier-Transform Infrared Spectroscopy (FTIR) provided a characteristic

molecular fingerprint, while Mass Spectrometry (MS) confirmed the exact molecular mass. This triad of tests offers absolute confidence in

the material’s correct stereochemistry and molecular structure—paramount for its intended biological activity. Residual solvent analysis also

confirmed compliance with ICH Q3C guidelines, ensuring the safety of the extraction and purification process. For pharmaceutical

companies developing generic or novel taxane-based therapies, this Blue Eyes Biotech Paclitaxel Extract provides a robust,

documentation-ready API foundation that streamlines regulatory submission and scale-up.

For the complete Certificate of Analysis (CoA), impurity profile, and pharmacopeial compliance report, contact the supplier:

Company:Blue Eyes Biotech CO., Ltd

Email:[email protected]

Website:www.blueeyes-bio.com

WhatsApp:+66840769830

Keywords: Paclitaxel Extract purity, USP/EP compliant API, Oncology drug ingredient, HPLC analysis, High-purity plant extract,

Pharmaceutical raw material, ICH guidelines, Related substances, Blue Eyes Biotech

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