Aquigen Bio Strengthens Its Impurity Standards Portfolio with New High‐Purity Compounds - Rude0214851/Blog GitHub Wiki

In an era where pharmaceutical precision, regulatory compliance, and data integrity are non-negotiable, Aquigen Bio continues to set industry benchmarks in impurity standard development. With a relentless commitment to quality and innovation, the company has recently expanded its Impurity Standards catalog to include well-characterized, high-purity compounds for Halcinonide, Ibandronate, Kaempferol, and Labetalol.

These latest additions bolster Aquigen Bio’s mission to support pharmaceutical manufacturers, CROs, academic institutions, and regulatory testing labs across the globe with critical reference materials required for drug development, quality control, and analytical validation.

What Are Impurity Standards and Why Are They Crucial? Impurities in drug substances and drug products — whether they arise during synthesis, formulation, storage, or degradation — must be identified and quantified to ensure drug safety and efficacy. Impurity Standards serve as benchmarks or reference substances to help laboratories detect, measure, and control these unwanted compounds.

Aquigen Bio’s impurity standards are synthesized or isolated using advanced techniques and undergo rigorous characterization via NMR, Mass Spectrometry, and HPLC, ensuring accuracy and reproducibility. These reference materials are vital for method validation, ICH stability studies, ANDA filings, and regulatory submissions.

Newly Released Impurity Standards by Aquigen Bio

1. Halcinonide Impurity 14 Product Page: https://aquigenbio.com/product/halcinonide-impurity-14/ Halcinonide is a potent topical corticosteroid used for various dermatological conditions. Aquigen Bio now offers Halcinonide Impurity 14, designed to meet stringent pharmacopeial requirements and support stability studies and batch validation.

The impurity is supplied with an extensive Certificate of Analysis (CoA), including spectral data to aid identification and quantification.

2. Ibandronate Impurity 3 & Impurity 4 Impurity 3: https://aquigenbio.com/product/ibandronate-impurity-3/ Impurity 4: https://aquigenbio.com/product/ibandronate-impurity-4/ Ibandronate, a bisphosphonate used in the treatment of osteoporosis, requires precise control over degradation products and synthetic impurities. These impurity standards are critical for ensuring product safety over its lifecycle.

Aquigen’s Ibandronate impurities are ideal for method development, specificity studies, and quantitation in both API and finished formulations.

3. Kaempferol 3-O-6-O-p-coumaroylglucoside Product Page: https://aquigenbio.com/product/kaempferol-3-o-6-o-p-coumaroylglucoside/ Kaempferol is a flavonoid with promising antioxidant and anti-inflammatory properties, widely used in nutraceuticals and botanical formulations. This rare and highly specific glycoside derivative, Kaempferol 3-O-6-O-p-coumaroylglucoside, enables herbal manufacturers and analytical scientists to conduct precise identity and purity assays.

With complete spectroscopic and chromatographic profiles, this impurity standard is perfect for natural product labs, herbal QC departments, and academic research.

4. Labetalol Impurity Standard Product Page: https://aquigenbio.com/products/impurity-standards/labetalol/ Labetalol is an important beta-blocker indicated for high blood pressure and hypertensive emergencies. With the increasing demand for generic formulations, impurity profiling of Labetalol is crucial to meet FDA and EMA regulatory expectations.

Aquigen’s impurity standards enable quality teams to conduct peak identification, impurity quantification, and robustness testing in a regulatory-compliant manner.

Why Aquigen Bio? What makes Aquigen Bio a preferred choice for pharmaceutical companies across the globe?

High Purity Guarantee: All impurity standards are ≥95% pure (unless otherwise specified), with full documentation. Comprehensive CoA: Each product is accompanied by validated HPLC, MS, and NMR data for reproducibility and reliability. Global Reach: With a robust shipping and support network, Aquigen Bio serves clients in North America, Europe, Asia-Pacific, and the Middle East. Research-Driven: Continuous product development focused on rare impurities and novel intermediates. Supporting Every Stage of Your Analytical Lifecycle From method development to stability studies, validation, and batch release, Aquigen Bio’s impurity standards play a pivotal role in helping pharmaceutical organizations maintain quality and meet evolving regulatory standards.

Whether you’re developing a new generic drug or maintaining a marketed product’s lifecycle, Aquigen’s impurities provide the accuracy and dependability that modern laboratories demand.

Explore Our Impurity Standards Portfolio: Halcinonide Impurity Standard Ibandronate Impurity Standards Kaempferol Impurity Standards Labetalol Impurity Standards About Aquigen Bio Based in India, Aquigen Bio is a pioneer in the development and supply of pharmaceutical impurity standards and reference materials. The company’s product line includes impurity standards for APIs, drug metabolites, degradation products, and phytochemicals. Aquigen supports regulatory submissions across the globe and is a key player in pharmaceutical analytical science.