About FLUPIRTINE MALEATE IP
FLUPIRTINE MALEATE is used to relieve mild to moderate pain and inflammation associated with muscle pain involving the musculoskeletal system, tension headaches, dental extraction, muscle spasm, tumour or cancer pain, and pain after trauma-related/orthopaedic surgery and injuries.Superior Pharmaceutical Grade QualityFlupirtine Maleate IP is manufactured to stringent pharmaceutical standards, with a purity of not less than 99% and total impurities below 0.5%. The product complies with industry-standard analytical methods such as IR and HPLC, ensuring reliability and safety for medicinal applications. Its stability and robust packaging further enhance its suitability for bulk drug manufacturing.
Optimized Packaging and Shelf LifeThis API is securely packed in double LDPE bags within fiber drums, each containing 25 kg net weight. These measures, along with recommended storage in cool, dry conditions protected from light and moisture, maintain Flupirtine Maleate's quality and extend its shelf life to 36 months from the manufacturing date.
Broad Applications in Pharmaceutical ManufacturingFlupirtine Maleate IP serves as a crucial intermediate and API for producing analgesic and muscle relaxant drugs. Its efficacy, physical properties, and compliance with international pharmacopoeias make it an ideal choice for formulators, manufacturers, and organizations seeking superior quality raw materials for pain management medicines.
FAQ's of FLUPIRTINE MALEATE IP:
Q: How is Flupirtine Maleate IP used in pharmaceutical manufacturing?
A: Flupirtine Maleate IP is primarily utilized as an active ingredient in the formulation of prescription analgesic and muscle relaxant medications. Its high purity, low impurity profile, and compliance with regulatory standards make it an essential component for pharmaceutical manufacturers.
Q: What are the recommended storage conditions for Flupirtine Maleate IP?
A: It should be stored in a cool and dry environment, away from direct light and moisture, to maintain its stability and extend its shelf life. The product is appropriately packaged in double LDPE bags within fiber drums to further safeguard its integrity.
Q: When does Flupirtine Maleate IP expire and how long is its shelf life?
A: Flupirtine Maleate IP has a shelf life of 36 months from the date of manufacture, provided it is stored under recommended conditions. This ensures the active ingredient remains effective and safe for pharmaceutical use throughout its intended period.
Q: Where is Flupirtine Maleate IP commonly sourced from?
A: This product is manufactured, supplied, and traded in India, where it is produced according to international pharmaceutical quality and safety requirements.
Q: What are the benefits of using Flupirtine Maleate IP in drug formulations?
A: Using Flupirtine Maleate IP offers benefits such as high purity, compliance with strict pharmacopoeia standards, reliable physical and chemical properties, enhanced efficacy, and assured microbiological safety, leading to consistent and effective medicinal products.
Q: How is Flupirtine Maleate IP identified and tested for quality?
A: Quality assurance involves identification by Infrared Spectroscopy (IR) and High-Performance Liquid Chromatography (HPLC), along with tests assessing specific rotation, impurities, microbial limits, and assay values to meet pharmaceutical-grade criteria.
Q: What is the molecular formula and typical appearance of Flupirtine Maleate IP?
A: The molecular formula of Flupirtine Maleate IP is C15H17FN4O2.C4H4O4. It is a white to off-white crystalline powder with a characteristic odor and specific particle size for optimal formulation.