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Human coagulation factor IX (rDNA)
Human coagulation factor IX (rDNA)

Human coagulation factor IX (rDNA)

Human coagulation factor IX (rDNA) Specification

  • Taste
  • Tasteless
  • CAS No
  • 9002-08-0
  • Grade
  • Pharmaceutical Grade
  • Product Type
  • Pharmaceutical Raw Material
  • Properties
  • Highly purified recombinant protein, free from human plasma proteins, sterile
  • Poisonous
  • Non-poisonous
  • Appearance
  • White to off-white lyophilized cake or powder
  • Melting Point
  • Not applicable (lyophilized protein)
  • Refractive Rate
  • Not Determined
  • Physical Form
  • Lyophilized Powder
  • Molecular Weight
  • ~55,000 Da
  • Purity
  • >99%
  • HS Code
  • 30021010
  • Ph Level
  • 7.07.4 (reconstituted solution)
  • Structural Formula
  • Recombinant protein structure analogous to human plasma-derived Factor IX
  • Shelf Life
  • 2436 Months (unopened vial at recommended temperature)
  • Usage
  • Used in intravenous injection after reconstitution with sterile water
  • Solubility
  • Completely soluble in water (upon reconstitution)
  • Ingredients
  • Human coagulation factor IX (recombinant), stabilizers, buffer agents
  • Storage
  • Store at 2C to 8C; protect from light
  • Density
  • Gram per cubic centimeter(g/cm3)
  • EINECS No
  • 232-625-2
  • Molecular Formula
  • C2339H3614N648O712S17 (approximate for protein backbone)
  • Smell
  • Odorless
  • Shape
  • Solid/Amorphous
  • Application
  • Treatment and prevention of bleeding in patients with hemophilia B
  • Packaging
  • Single use glass vial with diluent
  • Endotoxin Level
  • <1.0 EU/IU
  • Activity
  • >250 IU/vial (varies depending on presentation)
  • Manufacturer Certification
  • GMP, ISO certified
  • Administration Route
  • Intravenous injection
  • Allergen Information
  • Free from known allergens
  • Virus Safety
  • Viral inactivation/removal steps included during manufacturing
 

Human coagulation factor IX (rDNA) Trade Information

  • Main Domestic Market
  • All India
 

About Human coagulation factor IX (rDNA)

Human coagulation factor IX (rDNA)

European Pharmacopoeia (EP) Reference Standard



Premium Quality and Safety Assured

This recombinant Factor IX is produced using advanced technology, resulting in a highly purified, plasma-free protein with over 99% purity. Each batch is rigorously tested for viral contaminants, endotoxin levels (<1.0 EU/IU), and allergenicity. Manufactured following GMP and ISO certifications, this product guarantees consistent quality and patient safety.


Easy Administration and Convenient Packaging

Each vial contains lyophilized powder along with a suitable diluent for reconstitution. It is designed for intravenous injection, ensuring rapid and effective delivery. The single-use glass vial packaging maintains sterility and product integrity, making it convenient for use in hospitals, clinics, or home-care settings.

FAQs of Human coagulation factor IX (rDNA):


Q: How is Human coagulation factor IX (rDNA) administered?

A: This product is administered intravenously after reconstitution with the provided sterile diluent. Healthcare professionals typically perform the injection to ensure proper dosage and technique.

Q: What are the main benefits of using this recombinant Factor IX?

A: Key benefits include its high purity (>99%), absence of human plasma proteins, free-from-allergens formulation, and robust viral safety measures. These features reduce the risk of immune reactions and pathogen transmission.

Q: When should Human coagulation factor IX (rDNA) be used?

A: It is used for the treatment and prevention of bleeding episodes in patients diagnosed with hemophilia B, particularly during surgeries, injury, or spontaneous bleeding events.

Q: Where should this product be stored to maintain its effectiveness?

A: Store the unopened vial at 2C to 8C and protect it from light. Proper storage conditions help preserve the stability and efficacy of the product throughout its 2436 month shelf life.

Q: What is the process for preparing this medication before administration?

A: Before use, reconstitute the lyophilized powder with the included sterile diluent according to the instructions. Gently mix until dissolved and use the solution immediately for intravenous injection.

Q: Is Human coagulation factor IX (rDNA) suitable for individuals with allergies?

A: Yes, this recombinant product is free from known allergens, making it suitable for patients with common allergies or sensitivities to plasma-derived products.

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