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RIFAXIMIN EP/ BP

Name: RIFAXIMIN EP/ BP
Brand: IPSUM LIFESCIENCES LLP
Price: 1800 INR
Availability: InStock

Price 1800 INR/ Kilograms

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MOQ : 25 Kilograms

RIFAXIMIN EP/ BP Specification

Residue on Ignition
Not more than 0.2%

Melting Point
> 200C (decomposes)

Place of Origin
India

Moisture (%)
Not more than 4.0% (by KF)

HS Code
29419090

Molecular Formula
C43H51N3O11

Loss on Drying
Not more than 4.0%

Storage
Store in a tightly sealed container, protected from light and moisture, at 2C to 8C

Boiling point
Not applicable (decomposes before boiling)

Heavy Metal (%)
Not more than 0.001%

Particle Size
Not more than 10% above 40 microns

Assay
98.0% to 102.0% (on anhydrous basis)

Molecular Weight
785.9 g/mol

Other Names
Rifaximinum; Rifaximin EP/BP; Rifaximin Hemihydrate

CAS No
80621-81-4

Type
Pharmaceutical Raw Material

Grade
Pharma Grade

Usage
Active Pharmaceutical Ingredient (API) mainly for the treatment of gastrointestinal infections, hepatic encephalopathy, and travelers diarrhea

Purity
98.0% min (as per BP/EP)

Appearance
Crystalline Powder

Application
Antibacterial, gastrointestinal infections, hepatic encephalopathy

Raw Material
Yes

Smell
Odourless or almost odourless

Color
Red-orange

Form
Solid

Microbial Limits
Total aerobic microbial count: NMT 1000 cfu/g, Total yeast and mould: NMT 100 cfu/g, Absence of Escherichia coli and Salmonella spp.

Impurities
Complies with BP/EP requirements

Shelf Life
36 months from date of manufacture when stored as recommended

Pharmacopoeia compliance
EP/BP

Solubility
Practically insoluble in water, slightly soluble in methanol and acetone

Packaging
HDPE drums with inner double polyethylene bags, net weight 1kg, 5kg, 10kg or as per customer requirement

Identification
Confirmed by IR, UV & HPLC methods

About RIFAXIMIN EP/ BP

Rifaximin demonstrates good solubility in methanol and limited solubility in ethanol, facilitating its formulation in pharmaceutical applications. Proper storage in tightly sealed containers, protected from light and moisture at temperatures not exceeding 25C, ensures its stability until use. This antibiotic is essential for effective treatment of gastrointestinal bacterial infections, meeting rigorous pharmacopoeial standards for safety and effectiveness in healthcare applications.

Pharmaceutical Grade Assurance

RIFAXIMIN EP/BP is manufactured to meet stringent European and British Pharmacopoeia (EP/BP) requirements, ensuring high purity (98.0% min), strict impurity control, and optimal microbial standards. This raw material adheres to global regulatory benchmarks, making it a reliable choice for pharmaceutical manufacturers.

Flexible Packaging and Application

Available in HDPE drums with double polyethylene inner bags, RIFAXIMIN EP/BP is supplied in standard sizes of 1kg, 5kg, and 10kg, with custom options available. It serves mainly as an antibacterial API for gastrointestinal and hepatic conditions, ensuring precise dosing and safe handling for formulation needs.

Stability and Storage Solutions

To maximize potency and shelf life, RIFAXIMIN EP/BP should be stored between 2C and 8C in well-sealed containers, away from light and moisture. Following these guidelines preserves its chemical stability and safeguards its pharmacological efficacy for the full 36 months from manufacture.

FAQ's of RIFAXIMIN EP/ BP:

Q: How should RIFAXIMIN EP/BP be stored to maintain its stability?

A: RIFAXIMIN EP/BP should be kept in a tightly sealed container, protected from light and moisture, at a temperature between 2C and 8C. Adhering to these conditions will ensure its quality and stability for up to 36 months from the date of manufacture.

Q: What identification methods are used to confirm the authenticity of RIFAXIMIN EP/BP?

A: The authenticity of RIFAXIMIN EP/BP is confirmed using IR (infrared), UV (ultraviolet), and HPLC (high-performance liquid chromatography) methods, aligning with pharmacopeial guidelines.

Q: Where does RIFAXIMIN EP/BP originate from and in what packaging is it available?

A: RIFAXIMIN EP/BP is manufactured in India and supplied in HDPE drums with inner double polyethylene bags. Standard packaging options include net weights of 1kg, 5kg, and 10kg, with flexibility for customer-specific requirements.

Q: What are the main pharmaceutical applications of RIFAXIMIN EP/BP?

A: RIFAXIMIN EP/BP is mainly utilized as an active ingredient for the treatment of gastrointestinal infections, hepatic encephalopathy, and traveler's diarrhea due to its potent antibacterial properties.

Q: How is the compliance of RIFAXIMIN EP/BP with pharmacopoeia and impurity limits ensured?

A: RIFAXIMIN EP/BP fully complies with EP/BP standards for purity (98.0% min), impurities, and microbial limits, including total aerobic microbial count (NMT 1000 cfu/g), total yeast and mould (NMT 100 cfu/g), and absence of E. coli and Salmonella.

Q: What are the physical and chemical characteristics of RIFAXIMIN EP/BP?

A: It is a red-orange, crystalline powder that is odorless or almost odorless. RIFAXIMIN EP/BP is practically insoluble in water, slightly soluble in methanol and acetone, and stable up to temperatures exceeding 200C, where it decomposes.

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