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Human coagulation factor IX (rDNA)

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Human coagulation factor IX (rDNA) Specification

Density
Gram per cubic centimeter(g/cm3)

Purity
>99%

Grade
Pharmaceutical Grade

Physical Form
Lyophilized Powder

Taste
Tasteless

Molecular Formula
C2339H3614N648O712S17 (approximate for protein backbone)

Refractive Rate
Not Determined

Solubility
Completely soluble in water (upon reconstitution)

Ph Level
7.07.4 (reconstituted solution)

Properties
Highly purified recombinant protein, free from human plasma proteins, sterile

Product Type
Pharmaceutical Raw Material

Usage
Used in intravenous injection after reconstitution with sterile water

Storage
Store at 2C to 8C; protect from light

HS Code
30021010

CAS No
9002-08-0

Ingredients
Human coagulation factor IX (recombinant), stabilizers, buffer agents

Shelf Life
2436 Months (unopened vial at recommended temperature)

Melting Point
Not applicable (lyophilized protein)

Appearance
White to off-white lyophilized cake or powder

Structural Formula
Recombinant protein structure analogous to human plasma-derived Factor IX

Smell
Odorless

Shape
Solid/Amorphous

Poisonous
Non-poisonous

Molecular Weight
~55,000 Da

Application
Treatment and prevention of bleeding in patients with hemophilia B

EINECS No
232-625-2

Activity
>250 IU/vial (varies depending on presentation)

Virus Safety
Viral inactivation/removal steps included during manufacturing

Endotoxin Level
<1.0 EU/IU

Packaging
Single use glass vial with diluent

Administration Route
Intravenous injection

Allergen Information
Free from known allergens

Manufacturer Certification
GMP, ISO certified

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

Properties

Related Categories

Analytical Standards, Analytical/Chromatography, EP Standards, EP Standards G - H, Pharmacopeia & Metrological Institutes Standards

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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