Price 1800 आईएनआर/ Kilograms

मूल्य/उद्धरण प्राप्त करें

MOQ : 25 Kilograms

Specification

स्टोरेज

परख
98.0% to 102.0% (on anhydrous basis)

क्वथनांक
Not applicable (decomposes before boiling)

एच एस कोड
29419090

कण का आकार
Not more than 10% above 40 microns

नमी (%)
Not more than 4.0% (by KF)

आणविक भार
785.9 g/mol

आण्विक सूत्र
C43H51N3O11

उत्पत्ति का स्थान
India

भारी धातु (%)
Not more than 0.001%

इग्निशन पर अवशेष
Not more than 0.2%

सूखने पर नुक्सान
Not more than 4.0%

मेल्टिंग पॉइंट
> 200°C (decomposes)

दुसरे नाम
Rifaximinum; Rifaximin EP/BP; Rifaximin Hemihydrate

कैस नं
80621-81-4

टाइप करें

ग्रेड

उपयोग
Active Pharmaceutical Ingredient (API) mainly for the treatment of gastrointestinal infections, hepatic encephalopathy, and traveler’s diarrhea

पवित्रता
98.0% min (as per BP/EP)

दिखावट
Crystalline Powder

एप्लीकेशन

कच्चा माल
Yes

गंध

रंग

प्रपत्र

Impurities
Complies with BP/EP requirements

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

Identification
Confirmed by IR, UV & HPLC methods

Pharmacopoeia compliance
EP/BP

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

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.

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

About

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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