Aquigen Bio Introduces N‐Nitroso Pirfenidone EP Impurity B - A High-Purity Reference Standard for Pharmaceutical Analysis, Method Validation, and Regulatory Compliance in Pirfenidone Impurity Profiling

Pune-/Delran- Aquigen Bio is pleased to announce the introduction of N‐Nitroso Pirfenidone EP Impurity B, a premium reference standard designed for the highest rigor in pharmaceutical analysis and regulatory compliance. Available via custom‐synthesis, this product serves as an essential resource for analytical method development (AMD), method validation (AMV), quality control (QC), and support for Abbreviated New Drug Applications (ANDA)

https://aquigenbio.com/product/n-nitroso-pirfenidone-ep-impurity-b/
Product Highlights

Name: N‐Nitroso Pirfenidone EP Impurity B
Catalog No: AQ‐N000968
CAS No: 2512237‐43‐1
Molecular Formula: C6H6N2O2
Molecular Weight: 138.1
Chemical Name: 5‐methyl‐1‐nitrosopyridin‐2(1H)‐one
Availability: Custom synthesis, ready to dispatch within 24 hours (backorder)
Application: Ideal analytical standard with traceability to pharmacopeial references (USP/EP), used in regulatory submissions and lab QC processes.

Why This Matters
Analytical precision has never been more critical. Regulatory agencies demand exact identification and quantification of impurities-especially nitrosamines, classed as potentially carcinogenic. N‐Nitroso Pirfenidone EP Impurity B delivers:
Confidence in method validation and QC through consistent, character‐verified standards.

Compliance with global regulatory guidelines, thanks to full documentation and traceability potential.
Efficiency by offering ready availability and streamlined logistics.
Aquigen Bio underscores that this product is strictly for analytical use and not intended for human consumption.

Safety & Handling
Your safety is paramount. To ensure responsible laboratory use, Aquigen Bio provides extensive guidelines, including:
Review of the Safety Data Sheet (SDS) for crucial handling instructions.
Use of appropriate Personal Protective Equipment (PPE)-like gloves, goggles, respirators, and lab coats.
Conducting procedures in well‐ventilated areas, such as fume hoods or controlled environments.
Proper labeling and storage to avoid contamination.
Adhering to local disposal laws for hazardous chemical waste.
Providing adequate training, emergency response, and incident reporting protocols.
These practices help maintain high safety standards in labs utilizing this impurity standard.

Related Category: Pirfenidone Impurity Standards
As part of Aquigen Bio's broader Pirfenidone impurity standards collection, this product is grouped under the Impurity Standards → Pirfenidone category, which includes a wide portfolio of pharmacopoeial reference compounds Aquigen Bio. You can explore additional related products here:

Category Link: Impurity Standards - Pirfenidone- AquigenBio
https://aquigenbio.com/products/impurity-standards/pirfenidone/

Product: N‐Nitroso Pirfenidone EP Impurity A
Complementing Impurity B, Aquigen also provides N‐Nitroso Pirfenidone EP Impurity A,
offering versatility for broader analytical profiling:

Catalog No: AQ‐N000969
CAS No: 126209‐21‐0
Molecular Formula: C6H7N3O
Molecular Weight: 137.1
Chemical Name: N‐(5‐methylpyridin‐2‐yl)nitrous amide
Status: Custom‐synthesized, ready to dispatch within 24 hours (backorder)
Use Cases: AMV, QC, ANDA contexts-mirroring the dual‐application nature of Impurity B

Safety: Not for human consumption; full documentation and safety measures provided
This standard allows analytical labs to address multiple impurity forms in Pirfenidone, reinforcing method robustness and regulatory readiness.
How to Request or Order
Aquigen Bio ensures a seamless procurement experience:
Submit an RFQ (Request for Quotation) with details such as quantity (MG, GM, KG), company information, and contact details.

Explore - N‐Nitroso Pirfenidone EP Impurity A
https://aquigenbio.com/product/n-nitroso-pirfenidone-ep-impurity-a/

Benefit from complete documentation, worldwide delivery, and product accuracy assurances
Production is backed by rapid dispatch capability-despite backorder status.

Final Thoughts
In the modern pharmaceutical landscape, analytical accuracy is not optional-it's essential. With N‐Nitroso Pirfenidone EP Impurity B, Aquigen Bio supports lab professionals and regulatory teams with a high‐integrity, well‐characterized impurity standard. Combined with Impurity A, the offering delivers comprehensive support for Pirfenidone impurity profiling.
For more details, documentation, or to initiate a quotation, please visit the list of Pirfenidone impurity standards.

Contact:
Aquigen Bio Sciences
281/1, Plot No 41,
Hinjawadi - Pirangut Rd,
Kasar Amboli, Pirangut,
Pune, Maharashtra 412108
Phone: +91 7030123794
Email: bd@aquigenbio.com
Visit: www.aquigenbio.com

About Aquigen Bio Sciences
Aquigen Bio Sciences is at the forefront of pharmaceutical excellence, serving as the leading resource for Pirfenione impurity standards in India. With a strong commitment to safety, innovation, and regulatory compliance, the organization specializes in impurity profiling, synthesis, and analysis, empowering pharmaceutical manufacturers globally with premier standards. Aquigen Bio Sciences' dedication to cutting-edge research ensures it remains a trusted partner in refining quality benchmarks across the pharmaceutical landscape.

This release was published on openPR.