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METFORMIN HCL IP/BP/EP/USP

Name: METFORMIN HCL IP/BP/EP/USP
Brand: IPSUM LIFESCIENCES LLP
Price: 1800 INR
Availability: InStock

Price 1800 INR/ Kilograms

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MOQ : 25 Kilograms

METFORMIN HCL IP/BP/EP/USP Specification

Assay
98.5% - 101.0%

Molecular Formula
C4H11N5HCl

Ph Level
5.5 - 7.0 (2% solution)

Heavy Metal (%)
0.001% Max

Molecular Weight
165.63 g/mol

Particle Size
D90 150 microns

EINECS No
214-492-7

Moisture (%)
0.5% Max

Loss on Drying
0.5% Max

Place of Origin
India

Boiling point
Not applicable (decomposes before boiling)

Storage
Store in a cool, dry place, protected from light

HS Code
29420090

Residue on Ignition
0.1% Max

Melting Point
223-226C (decomposes)

Other Names
1,1-dimethylbiguanide hydrochloride

CAS No
1115-70-4

Type
Pharmaceutical raw material

Grade
Pharmaceutical Grade

Usage
Anti-diabetic drug, Active pharmaceutical ingredient

Purity
99% Min

Appearance
White or almost white crystalline powder

Application
Used in formulation of anti-diabetic medicines

Raw Material
Yes

Smell
Odorless

Color
White

Form
Powder

Usage Category
API manufacturing, Bulk drug

Identification
Meets Ph. Eur/USP/IP/BP requirements

Shelf Life
3 Years

Microbial Limits
Total bacterial count: NMT 1000 cfu/g, Yeast & mold: NMT 100 cfu/g, E. coli/Salmonella: Absent

Solubility
Freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone, ether, and chloroform

Any Other Impurity
0.1%

Bacterial Endotoxins
Not more than 0.5 IU/mg

Impurity A (Individual)
0.1%

Packaging Type
HDPE Drum/Fiber Drum with double polyethylene bags

About METFORMIN HCL IP/BP/EP/USP

Metformin hydrochloride is a medication primarily used to treat type 2 diabetes. It works by reducing the production of glucose in the liver and enhancing the body's sensitivity to insulin, which helps lower blood sugar levels. Administered orally in tablet form, it is typically started at a low dose and gradually increased as needed.

Pharmaceutical-Grade Quality Assurance

Metformin HCL is crafted to fulfill the exacting standards of multiple international pharmacopeias, guaranteeing both purity and clinical effectiveness. With low impurity thresholds and minimal heavy metal content, this product maintains stringent quality controls for reliable pharmaceutical use.

Optimized Packaging and Storage

This bulk drug is packaged in HDPE or fiber drums equipped with double polyethylene bags, protecting against moisture and contaminants. Proper storage in cool, dry conditions, shielded from light, preserves its potency and extends shelf life to three years.

Versatile Application in Anti-Diabetic Formulation

As an active pharmaceutical ingredient, Metformin HCL is extensively used in the manufacturing of anti-diabetic medications. Its high solubility profile and consistent assay values make it suitable for large-scale drug formulation and pharmaceutical research.

FAQ's of METFORMIN HCL IP/BP/EP/USP:

Q: How is Metformin HCL typically used in pharmaceutical applications?

A: Metformin HCL serves as a key active pharmaceutical ingredient (API) in the formulation of anti-diabetic drugs. It is incorporated primarily in bulk drug manufacturing for medicines that help regulate blood sugar levels.

Q: What ensures the quality and safety of Metformin HCL IP/BP/EP/USP?

A: The product meets stringent international pharmacopeial identification standards (Ph. Eur/USP/IP/BP). Impurity levels, microbial limits, and heavy metals are tightly controlled, ensuring a minimum purity of 99% and compliance with industry safety requirements.

Q: When and how should Metformin HCL be stored for optimal shelf life?

A: It should be stored in a cool, dry place protected from light in HDPE or fiber drums with double polyethylene bags. This storage method maintains its potency and extends shelf life up to three years.

Q: Where is Metformin HCL manufactured and supplied from?

A: Metformin HCL is produced, supplied, and traded by various manufacturers located in India, ensuring a reliable source of high-quality pharmaceutical raw material for global markets.

Q: What is the process for testing impurities and microbial limits in Metformin HCL?

A: Impurities and microbial levels are measured through validated analytical methods according to pharmacopeial standards, including limits for Impurity A, other impurities, total bacterial count, yeast & mold, and the absence of specific pathogens such as E. coli and Salmonella.

Q: What are the major benefits of using pharmaceutical-grade Metformin HCL?

A: Pharmaceutical-grade Metformin HCL offers high purity, predictable performance, and compliance with drug safety regulations. This ensures efficacy in anti-diabetic formulations and reduces potential risks associated with contaminants.

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