Frequently Asked Questions

Impurity reference standards are highly characterized chemical substances used as benchmarks to identify, quantify, and qualify impurities present in pharmaceutical drug substances and drug products. They are essential for pharmaceutical registration dossiers, method validation, and quality control. LANING BIOTECHNOLOGY provides over 500 high-purity impurity reference standards covering cephalosporins, penicillins, carbapenems, nitrosamines, and other antibiotic categories.

Impurity reference standards are high-purity, fully characterized substances used as primary benchmarks for impurity identification and quantification. They come with complete spectral and analytical documentation (COA, NMR, MS, HPLC). Working standards are secondary standards qualified against the reference standard for routine quality control use. LANING BIOTECHNOLOGY specializes in primary impurity reference standards with full documentation suitable for pharmaceutical registration.

LANING BIOTECHNOLOGY offers impurity reference standards across 7 major categories:

• Cephalosporins impurities — including cefuroxime, cefotaxime, ceftriaxone impurities
• Penicillins impurities — including amoxicillin, ampicillin, dicloxacillin impurities
• Carbapenems impurities — including meropenem, imipenem, ertapenem impurities
• Other Antibiotics impurities
• Reference Standards — vitamin impurities, famotidine, daclatasvir
• Nitrosamines — NDMA, NDEA and other N-nitroso compounds
• Standard Substances — pharmaceutical standard reference materials

Most impurity reference standards from LANING BIOTECHNOLOGY should be stored at -20°C in a desiccator, protected from light and moisture. Specific storage conditions are indicated on each product's COA. Proper storage ensures the stability and integrity of the standard throughout its shelf life. We recommend allowing the standard to equilibrate to room temperature before opening to avoid moisture condensation.

Each impurity reference standard from LANING BIOTECHNOLOGY comes with a comprehensive Certificate of Analysis (COA) that includes:

• HPLC purity data
• H-NMR and C-NMR spectra
• Mass Spectrometry (MS) data
• UV and IR spectra
• Structural confirmation

This documentation meets ICH guidelines and is accepted by regulatory authorities including NMPA, FDA, and EMA for pharmaceutical registration submissions.

LANING BIOTECHNOLOGY's impurity reference standards typically achieve purity levels of 95% or higher as determined by HPLC. Some standards reach 98%+ purity. Each product's exact purity is specified on its Certificate of Analysis (COA). High purity is critical for accurate impurity quantification in pharmaceutical registration studies.

Yes, impurity reference standards are required for pharmaceutical registration in China under NMPA (National Medical Products Administration) regulations. LANING BIOTECHNOLOGY's standards with complete COA documentation are accepted for CTD (Common Technical Document) submissions. Our products are used by over 500 pharmaceutical companies for drug registration dossiers, method validation, and quality control.

Nitrosamine impurities are N-nitroso compounds that can form during pharmaceutical manufacturing. Since the 2018 valsartan recall, regulatory agencies including FDA, EMA, and NMPA have required nitrosamine risk assessment for all drug products. LANING BIOTECHNOLOGY offers a comprehensive range of nitrosamine impurity reference standards to support pharmaceutical companies in meeting these regulatory requirements.

Yes, LANING BIOTECHNOLOGY provides custom synthesis services for impurity reference standards that are not available in our standard catalog. Our in-house R&D laboratory specializes in synthesizing and characterizing novel impurities. Custom synthesis typically includes:

• Route design and synthesis
• Purification
• Full structural characterization (HPLC, NMR, MS, UV, IR)
• COA documentation

Contact us with your specific requirements for a quote.

For in-stock items, LANING BIOTECHNOLOGY ships within 1-3 business days. Domestic delivery in China takes 2-5 days. International shipping typically takes 5-15 business days depending on the destination. Custom synthesis projects require 2-8 weeks depending on complexity. We provide global shipping via courier (DHL, FedEx) and standard postal services.