Description

Nitrofurantoin- 13 C 3 is a stable isotope-labeled analog of the antibiotic nitrofurantoin, specifically enriched with three carbon-13 atoms. This compound is essential as an internal standard in quantitative mass spectrometry, ensuring the highest accuracy and reliability in analytical measurements. It is a critical material for pharmaceutical research, quality control laboratories, and clinical diagnostic developers who require precise quantification of nitrofurantoin in complex biological matrices.

Application

• Mass Spectrometry Internal Standard: Primary use as a quantitative reference standard in LC-MS/MS and GC-MS analysis for nitrofurantoin.
• Pharmacokinetic & Bioavailability Studies: Enables precise tracking and measurement of drug absorption, distribution, metabolism, and excretion (ADME) in biological samples.
• Clinical Research & Diagnostics: Used in developing and validating high-sensitivity assays for therapeutic drug monitoring (TDM) and clinical studies.
• Pharmaceutical Quality Control (QC): Critical for ensuring batch-to-batch consistency and verifying the purity and potency of nitrofurantoin API and finished drug products.
• Metabolite Identification & Profiling: Aids in the identification and quantification of nitrofurantoin metabolites in research settings.
• Regulatory Compliance Testing: Supports analytical methods required for submissions to regulatory bodies like the FDA and EMA.

Basic Information

Product Name	Nitrofurantoin- 13 C 3
CAS No.	1217226-46-4
Molecular Formula	C813C3H6N4O5
Molecular Weight	~243.16 g/mol (exact mass varies with isotopic enrichment)
Synonyms	1-[[(5-Nitro-2-furanyl)methylene]amino]-2,4-imidazolidinedione-13C3; [13C3]-Nitrofurantoin; Nitrofurantoin (carbon-13 labeled); Nitrofurantoin-13C3; Furadantin-13C3; Macrobid-13C3; Isotopically Labeled Nitrofurantoin; Nitrofurantoin Internal Standard
EINECS	Contact for details

Quality Control

Every batch of Nitrofurantoin- 13 C 3 is manufactured and analyzed under strict quality systems. We provide comprehensive analytical data to support its use in regulated environments, including NMR and Mass Spectrometry for isotopic enrichment and structural confirmation, and HPLC for chemical and isotopic purity. A detailed Certificate of Analysis (COA) is supplied with each product, documenting batch-specific results. Our quality commitment ensures compliance with the rigorous standards expected in pharmaceutical and clinical research.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	Yellow to orange crystalline powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Isotopic Enrichment	≥ 99 atom % 13C
Chemical Purity (HPLC)	≥ 98.0%
Isotopic Purity (HPLC-MS)	≥ 99.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.