Standalix Impurity and DNPH Standards for Pharmaceutical Quality Control

Standalix Impurity and DNPH Standards for Pharmaceutical Quality Control

Standalix is a specialized brand in impurity and nitrosamine reference standards for active pharmaceutical ingredients (APIs).

In recent years, nitrosamine impurities have been closely studied due to their potential carcinogenic risk at different exposure levels. As a result, controlling and minimizing nitrosamines in the drug supply has become a key priority worldwide.

Standalix supports pharmaceutical laboratories by providing the reference standards required for reliable detection, identification and quantification.

Why choose Standalix?

• Trusted quality: Strict quality control for consistent performance and reproducible results.
• Extensive catalogue: Over 7,000 impurity and nitrosamine standards aligned with analytical and regulatory requirements.
• Fast delivery: Typical lead time of 2–3 weeks across Europe.
• Competitive pricing: Practical cost structure designed for routine and frequent analytical use.

Each product is supplied with the documentation required for regulatory assessment and compliance, including CoA and MSDS, supporting analytical data such as HPLC, MS (Mass), HNMR, and TGA. Additional documentation can be provided upon request.

Costumer favorite:

2,4-Dinitrophenyl)hydrazine (DNPH) is one of the most sold products in the Standalix portfolio. It is a highly selective derivatization reagent widely used in the pharmaceutical industry for the detection and quantification of reactive carbonyl impurities (aldehydes and ketones) in APIs and excipients.

Key pharmaceutical applications of DNPH:

• API & excipient testing: Identifies reactive impurities from synthesis or storage to ensure long-term medication shelf life.
• Medical device testing (ISO 18562-3): Critical for detecting VOCs and carbonyls in respiratory equipment, to ensure inhalation safety.
• Extractables and leachables (E&L): Detects harmful aldehydes that may migrate from primary packaging or delivery systems into the drug formulation.

CymitQuimica and Standalix empower laboratories to meet strict regulatory requirements while safeguarding patient health.

For assistance in selecting the right reference standards for your analytical workflow, contact support@cymitquimica.com.