Description

Nolotil CAS NO 54017-59-3 is a pharmaceutical-grade active pharmaceutical ingredient (API) primarily known as the analgesic and antipyretic agent Metamizole. This compound is valued for its potent non-opioid pain-relieving and fever-reducing properties, making it a critical component in therapeutic formulations. It is essential for pharmaceutical manufacturers producing injectable solutions, tablets, and other dosage forms aimed at managing moderate to severe pain and high fever. Our supply chain ensures consistent quality and reliable availability to meet the stringent demands of global drug production.

Application

• Analgesic Formulations: Primary API in prescription and over-the-counter medications for the treatment of moderate to severe pain, including post-operative and cancer pain.
• Antipyretic Medications: Key ingredient in fever-reducing drugs, effective for managing high fever in both adult and pediatric populations where applicable.
• Injectable Solutions: Used in the manufacture of sterile injectable products for rapid onset of action in clinical and hospital settings.
• Oral Solid Dosage Forms: Incorporated into tablets, capsules, and powders for convenient oral administration.
• Veterinary Pharmaceuticals: Employed in veterinary medicine for pain management and fever reduction in animals.
• Combination Therapies: Can be formulated with other APIs like antispasmodics to enhance therapeutic efficacy for specific conditions.

Basic Information

Product Name	Nolotil
CAS No.	54017-59-3
Molecular Formula	C13H16N3NaO4S
Molecular Weight	333.34 g/mol
Synonyms	Metamizole Sodium; Dipyrone; Noramidopyrine Methanesulfonate Sodium; Analgin; Novalgin; Sulpyrine; Sodium [(2,3-Dihydro-1,5-dimethyl-3-oxo-2-phenyl-1H-pyrazol-4-yl)methylamino]methanesulfonate; 1-Phenyl-2,3-dimethyl-4-methylaminopyrazolone-5-N-methanesulfonic acid sodium salt
EINECS	Contact for details

Quality Control

Our Nolotil (Metamizole Sodium) is manufactured under strict cGMP guidelines to ensure the highest standards of purity and safety for pharmaceutical use. Each batch undergoes comprehensive analytical testing, including identification, assay, and impurity profiling via advanced techniques like HPLC and IR spectroscopy. A Certificate of Analysis (COA) documenting compliance with in-house specifications, which align with major pharmacopoeial standards, is provided with every shipment to guarantee traceability and quality assurance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed to prevent moisture absorption, which can affect stability and potency. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (Karl Fischer)	≤ 5.0%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
pH (5% solution)	6.0 - 8.0
Bacterial Endotoxins	< 0.25 EU/mg (for injectable grade)
Sterility	Sterile (for injectable grade, tested accordingly)

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