In the highly regulated world of pharmaceuticals, impurity profiling is not just about quality — it’s about safety, efficacy, and regulatory compliance. At Aquigen Bio, we specialize in providing high-purity, well-characterized impurity standards that support the global pharmaceutical industry’s mission to deliver safe medications.
Today, we spotlight four key products:
👉 Ibandronate Impurity 3
👉 Ibandronate Impurity 4
👉 Halcinonide Impurity 12
👉 Halcinonide Impurity 13
Ibandronate Impurities: Supporting Bone Health Treatments
Ibandronate is widely used to prevent and treat osteoporosis, particularly in postmenopausal women. Like all active pharmaceutical ingredients (APIs), Ibandronate must be monitored for impurities that may form during synthesis, degradation, or storage.
Ibandronate Impurity 3
- Purpose: Used in analytical method development and stability testing
- Significance: Identifying and quantifying Impurity 3 ensures the final product remains within acceptable safety limits, supporting ICH guidelines.
Ibandronate Impurity 4
- Purpose: Crucial for stress testing and long-term stability studies
- Benefit: Enables pharmaceutical companies to evaluate degradation pathways, enhancing drug shelf-life and patient safety.
At Aquigen Bio, both impurities are synthesized under stringent conditions to meet the highest quality specifications — ensuring reproducibility and regulatory compliance for your analytical studies.
Halcinonide Impurities: Ensuring Dermatological Safety
Halcinonide is a potent corticosteroid used topically to treat skin conditions such as eczema, psoriasis, and dermatitis. Because it’s a steroidal compound, impurity formation must be carefully controlled due to potential side effects even at low concentrations.
Halcinonide Impurity 12
- Application: Used during HPLC method validation and impurity profiling
- Advantage: Enables precise quantification of degradation products and byproducts formed during formulation or exposure to light/heat.
Halcinonide Impurity 13
- Application: Supports forced degradation studies under accelerated conditions
- Value: Helps meet USFDA and EMA requirements for impurity identification above threshold levels.
These impurity standards are indispensable in topical drug development pipelines where safety margins are narrow and precision is critical.
Why Choose Aquigen Bio Impurity Standards?
At Aquigen Bio, we take pride in delivering certified impurity reference standards that are:
- Characterized with advanced analytical techniques (NMR, LC-MS, IR, HPLC)
- Accompanied by COAs, spectral data, and MSDS
- Available in custom pack sizes for R&D, regulatory filings, and quality control labs
Our commitment to quality, traceability, and global regulatory standards ensures our partners in pharma can proceed with confidence — whether it’s for method development, ANDA filing, or routine QC.
Final Thoughts
Impurities, though present in trace amounts, can have significant consequences on drug safety and regulatory approval. With high-quality standards like Ibandronate Impurity 3 & 4 and Halcinonide Impurity 12 & 13, Aquigen Bio enables the pharmaceutical ecosystem to uphold its promise: safe, effective, and compliant medications.
Ready to strengthen your analytical capabilities?
Explore our full impurity catalogue at Aquigen Bio